[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"liver-fibrosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:liver-fibrosis":30},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,39,0,25,[9,44,71,95,148,188,219,241,268,297,319,349,372,392,416,444,468,491,515,536,558,578,606,630,656],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100492966","screening-in-primary-care-of-advanced-liver-fibrosis-in-nafld-andor-alcoholic-patients-100492966",false,"NCT05699018","Screening in Primary Care of Advanced Liver Fibrosis in NAFLD and\u002For Alcoholic Patients","SOPRANO","Inclusion Criteria:\n\n* NAFLD and\u002For ALD patient defined by at least 1 of the following criteria:\n\n  * Excessive alcohol consumption: higher than 210 g \u002F week (men), or 140 g \u002F week (women)\n  * Type 2 diabetes\n  * at least 2 metabolic factors among BMI higher than or equal to 25 kg \u002F m 2; Elevated blood pressure (antihypertensive drug, or systolic blood pressure higher than or equal to 130mmHg, or diastolic blood pressure higher than or equal to 85mmHg), Dyslipidemia (lipid-lowering drug, or HDL cholesterol lower to 40mg\u002Fdl (men) \u002F 50mg\u002Fdl (women), or triglycerides higher than or equal to150mg\u002Fdl); Hyperferritinemia (higher than upper limit of normal from the laboratory)\n  * Bright liver at ultrasonography without steatosis-inducing drug(systemic corticosteroids, tamoxifen, amiodarone, methotrexate)\n\nFollowing a protocol amendment, the 3 last investigating primary care centres will include NAFLD and\u002For ALD patients according to these updated criteria:\n\n* Excessive alcohol consumption: \\>210 g\u002Fweek in men or \\>140 g\u002Fweek in women,\n* AND\u002FOR type 2 diabetes treated with insulin and\u002For at least two other anti-diabetic treatments,\n* AND with the following stratification:\n\n  30% with excessive alcohol consumption 65% with type 2 diabetes treated with insulin and\u002For at least two other anti-diabetic treatments 5% with both conditions (excessive alcohol consumption, AND type 2 diabetes treated with insulin and\u002For at least two other anti-diabetic treatments)\n* Patient's agreement to have a blood sample collected in a local laboratory participating in the study\n* Subjects covered by or having the rights to medical care assurance\n* Written informed consent obtained from subject\n\nExclusion Criteria:\n\n* Already ongoing specialized follow-up for a chronic liver disease\n* Altered health status with poor short-term prognosis, not compatible with a screening procedure\n* Decompensated cirrhosis (hepatic encephalopathy, jaundice, ascites, variceal bleeding, hepatorenal syndrome)\n* Acute infection\n* Pregnancy, breastfeeding\n* Persons in detention by judicial or administrative decision\n* Person admitted to a health or social establishment for purposes other than research\n* Person subject to a legal protection measure\n* Person unable to express consent","ALL","40 Years","80 Years",{"count":21,"type":22},1788,"ESTIMATED","INTERVENTIONAL",[25],"NA","The primary objective of the SOPRANO study is to compare two blood fibrosis tests, the eLIFT and the FibroMeter, for the screening of advanced liver fibrosis in patients with NAFLD and\u002For ALD from primary care centers.",[28,29,30],"Non-alcoholic Fatty Liver Disease (NAFLD)","Alcoholic Liver Disease (ALD)","Liver Fibrosis","RECRUITING","2026-06-26",{"date":34,"type":35},"2026-06-30","ACTUAL",{"date":37,"type":35},"2023-03-13",{"date":39,"type":22},"2026-09-12",{"name":41,"class":42},"University Hospital, Angers","OTHER_GOV",13,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":70},"100638473","phase-2-study-of-azd2389-safety-tolerability-and-pharmacodynamics-in-adults-with-steatotic-liver-disease-and-advanced-fibrosis-100638473","NCT07610837","Study of AZD2389 Safety, Tolerability, and Pharmacodynamics in Adults With Steatotic Liver Disease and Advanced Fibrosis","A Phase IIa, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of AZD2389 in Adult Participants With Steatotic Liver Disease and Advanced Fibrosis (BRAVO)","BRAVO","Key Inclusion Criteria:\n\n* Males\u002Ffemales aged 18 or over\n* A diagnosis of SLD with advanced fibrosis\n* No significant change in weight over the last 6 months\n* Contraceptive us by participants or participants partners\n* Capable of giving informed consent\n* Judged by the investigator to be suitable for study\n\nKey Exclusion Criteria:\n\n* Portal hypertension (LSM \\>25 kPa or 20-25 kPa with platelets \\\u003C150×10⁹\u002FL), decompensated liver disease, Child-Pugh \\>A6, MELD \\>12, other chronic liver diseases, prior\u002Fplanned liver transplant, or malignant liver tumors.\n* Positive viral infections, including HIV or hepatitis B, or hepatitis C unless HCV RNA-negative ≥12 weeks after treatment.\n* Alcohol intake above protocol thresholds, or positive screen for drugs of abuse.\n* Significant metabolic, cardiovascular, or GI disorders, including T1DM or insulin-treated T2DM, uncontrolled hypertension, recent major cardiac\u002Fcerebrovascular events, severe heart failure, serious arrhythmias, significant pancreatic disease, or major GI surgery.\n* History of psychosis, bipolar disorder, recent major depression, or suicide attempt\u002Fideation within 1 year.\n* Bleeding risk or wound-healing concerns, including coagulation disorders, major bleeding history, active wounds or recent major surgery, or severe dermatologic immune conditions.\n* Prohibited medications or hypersensitivities, including moderate\u002Fstrong CYP3A4 or BCRP\u002FOAT3 inhibitors\u002Finducers, anticoagulants\u002Fantiplatelets (except aspirin ≤81 mg\u002Fday), or hypersensitivity to DPP4 inhibitors.\n* Other protocol-defined exclusions, including significant abnormal labs (e.g., worsening ALT\u002FAST), recent participation in another IMP study, or investigator judgment of unsuitability.","18 Years",{"count":54,"type":22},104,[56],"PHASE2","The purpose of this study is to evaluate the safety, tolerability, and pharmacodynamic effects of AZD2389 in adult participants with steatotic liver disease (SLD) and advanced fibrosis.",[30,59],"Hepatic Cirrhosis",[30,59],"2026-06-25",{"date":32,"type":35},{"date":64,"type":35},"2026-05-07",{"date":66,"type":22},"2027-07-07",{"name":68,"class":69},"AstraZeneca","INDUSTRY",20,{"id":72,"slug":73,"hasResults":12,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":23,"phases":80,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":94},"100564689","phase-3-liverage-a-study-to-test-whether-survodutide-helps-people-with-a-liver-disease-called-nashmash-who-have-moderate-or-advanced-liver-fibrosis-100564689","NCT06632444","LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH\u002FMASH Who Have Moderate or Advanced Liver Fibrosis","A Randomised, Double-blind, Placebo-controlled, Multicentre, Phase III Trial Evaluating Long-term Efficacy and Safety of Survodutide Weekly Injections in Adult Participants With Noncirrhotic Non-alcoholic Steatohepatitis\u002FMetabolic Dysfunction-associated Steatohepatitis (NASH\u002FMASH) and (F2) - (F3) Stage of Liver Fibrosis","Inclusion criteria:\n\n1. Male or female participants ≥18 years (or who are of legal age in countries where that is greater than 18 years) of age at time of consent\n2. Diagnosis of MASH (non-alcoholic fatty liver disease (NAFLD)) activity score \\[NAS\\] ≥4\n3. Stable body weight defined as less than 5% self-reported change in body weight 3 months prior to the screening or during the period between the historical biopsy and randomisation, if a historical biopsy is used\n4. Be willing to maintain a stable diet and physical activity levels throughout the entire trial Further inclusion criteria apply\n\nExclusion criteria:\n\n1. Any of the following liver laboratory test abnormalities at screening:\n\n   * Serum AST and\u002For alanine aminotransferase (ALT) elevation ≥5x upper limit of normal (ULN)\n   * Platelet count \\\u003C140 000\u002Fmm\\^3 (\\\u003C140 GI\u002FL)\n   * Alkaline phosphatase \\>2x upper limit of normal (ULN)\n   * Abnormal synthetic liver function as defined by screening central laboratory evaluation:\n\n     * Albumin below \\\u003C3.5 g\u002FdL (35.0 g\u002FL)\n     * OR International normalised ratio (INR) of prothrombin time \\>1.3\n     * OR total serum bilirubin concentration ≥1.5x ULN\n2. Any history or evidence of acute or chronic liver disease other than MASH\n3. Histologically documented liver cirrhosis (fibrosis stage F4), either at screening or in a historical biopsy\n4. History of or current diagnosis of hepatocellular carcinoma\n5. History of or planned liver transplant\n6. Inability or unwillingness to undergo a liver biopsy at screening (if a suitable historical biopsy is unavailable for central review), or during trial conduct.\n7. History of portal hypertension or presence of decompensated liver disease\n8. Model for end-stage liver disease (MELD) score ≥12 due to liver disease. Further exclusion criteria apply",{"count":79,"type":22},1800,[81],"PHASE3","This study is open to adults who are at least 18 years old living with obesity and have:\n\n* a confirmed liver disease called non-alcoholic steatohepatitis (NASH)\u002Fmetabolic associated steatohepatitis (MASH) and\n* moderate or advanced liver fibrosis\n\nPeople with a history of acute or chronic liver diseases other than MASH or chronic alcohol intake cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps people with MASH and moderate or advanced liver fibrosis improve their liver function.\n\nThis study has 2 parts. The purpose of the first part of this study is to find out the effect of survodutide on MASH and liver fibrosis. The purpose of the second part is to find out how safe and effective survodutide is in improving liver function. Participants are put into 2 groups randomly, which means by chance. 1 group gets survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Each participant has twice the chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week. The survodutide doses are slowly increased until the target dose is reached. All participants receive counselling to make changes to their diet and to exercise regularly.\n\nParticipants are in the study for up to 7 years. During this time, they regularly visit the study site or have remote visits by video call. For about the first year of the study, participants have these visits every 2 weeks, increasing to every 4 weeks and then every 6 weeks. After being in the study for a little over a year participants will then alternate between visiting the study site or having a remote visit every 3 months until the end of the study.\n\nThe doctors check participants' health and take note of any unwanted effects. The participants' body weight and effects on the stomach and intestines are regularly measured. At some visits the liver is measured using different imaging methods. At 2 or 3 visits doctors take a small sample of liver tissue (biopsy). The participants also fill in questionnaires about their symptoms and quality of life. The results are compared between the groups to see whether the treatment works.",[84,30],"Metabolic Dysfunction Associated Steatohepatitis (MASH)","2026-06-23",{"date":87,"type":35},"2026-06-24",{"date":89,"type":35},"2024-09-17",{"date":91,"type":22},"2031-12-27",{"name":93,"class":69},"Boehringer Ingelheim",525,{"id":96,"slug":97,"hasResults":12,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":23,"phases":104,"briefSummary":105,"conditions":106,"keywords":125,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":139,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":147},"100526751","effect-of-endoscopic-sleeve-gastroplasty-in-patients-with-obesity-and-mash-a-randomized-controlled-trial-100526751","NCT06138821","Effect of Endoscopic Sleeve Gastroplasty in Patients With Obesity and MASH: A Randomized Controlled Trial","Effect of Endoscopic Sleeve Gastroplasty on Patients With Obesity and Concomitant Metabolic Dysfunction-Associated Steatohepatitis (MASH): A Multicenter, Open-label, Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age ≥ 18 (male or female)\n2. BMI ≥30 kg\u002Fm2 or ≥27 kg\u002Fm2 with at least one obesity-related comorbidity\n3. Self-reported stable weight (no weight change \\>5%) for 6 months prior to the first study visit\n4. Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing laboratory\u002Fimaging\u002Fadditional tests, and completing diet counseling\n5. Willingness to NOT start a new anti-obesity medication for the following 12 months\n6. Residing within a reasonable distance from the investigator's office and able to travel to the investigator to complete routine follow-up visits\n7. Ability to give informed consent\n8. Women of childbearing potential (i.e., not post-menopausal, nor surgically sterilized) must agree to use adequate birth control methods\n\nExclusion Criteria:\n\n1. Known history of other chronic liver diseases (viral hepatitis, autoimmune hepatitis, drug-induced hepatitis, and genetic)\n2. Treatment with vitamin E (at doses ≥800 IU\u002Fday), pioglitazone, obeticholic acid, or resmetirom \\\u003C90 days before the first study visit\n3. History of foregut or gastrointestinal (GI) surgery (except uncomplicated fundoplication, cholecystectomy or appendectomy)\n4. Prior bariatric surgery\n5. Prior endoscopic sleeve gastroplasty\n6. Any inflammatory disease of the GI tract, including severe (LA Grade C or D) esophagitis, Barrett's esophagus with dysplasia, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease\n7. Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias or stenoses\n8. Severe gastroesophageal reflux disease (GERD)\n9. A structural abnormality in the esophagus or pharynx, such as a stricture or diverticulum, that could impede passage of the endoscope.\n10. Achalasia or any other severe esophageal motility disorder\n11. Chronic abdominal pain\n12. Gastroparesis or intractable constipation\n13. Hepatic insufficiency or cirrhosis\n14. Severe coagulopathy\n15. Insulin-dependent diabetes (either type 1 or type 2) or a significant likelihood of requiring insulin treatment in the following 12 months or HgbA1C ≥ 12%\n16. Patients on an anti-platelet agent, anticoagulant agent or chronic\u002Froutine use of NSAIDs\n17. Patients on corticosteroids, immunosuppressants, or narcotics\n18. Patients on an anti-seizure or anti-arrhythmic medication\n19. Patients who are pregnant or breastfeeding\n20. Excessive alcohol consumption (\\>20 g per day for women; \\>30 g per day for men)\n21. Active smoking\n22. History of poorly controlled hypertension, coronary artery disease, congestive heart failure, cardiac arrhythmia\n23. History of respiratory diseases such as chronic obstructive pulmonary disease (COPD) requiring steroids, pneumonia, or cancer\n24. History of autoimmune connective tissue disorder such as lupus, scleroderma or immunocompromised disease\n25. History of active malignancy\n26. History of genetic or hormonal causes for obesity, such as Prader Willi syndrome\n27. History of endocrine disorders affecting weight, such as uncontrolled hypothyroidism\n28. Eating disorders, including night eating syndrome, bulimia, binge eating disorder or compulsive overeating\n29. Active psychological issues preventing participation in a lifestyle modification program as determined by a psychologist",{"count":103,"type":22},132,[25],"Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most common chronic liver disease globally. While weight loss through lifestyle modification is the standard treatment, most patients regain weight limiting ultimate improvement in liver disease. On the other end of the spectrum, bariatric surgery has shown promise in the treatment of MASLD\u002Fmetabolic dysfunction-associated steatohepatitis (MASH) due to its efficacy in inducing weight loss. Nevertheless, its adoption has been hindered by the perceived invasiveness of surgery.\n\nOver the past decade, endoscopic sleeve gastroplasty (ESG) has gained recognition as a promising minimally-invasive approach to weight loss. The procedure involves utilizing a Food and Drug Administration (FDA)-authorized endoscopic suturing device to reduce the gastric volume by 70%. Studies reveal that ESG is associated with approximately 18.2% weight loss at one year after the procedure, with sustained results for at least 10 years. Nevertheless, the effect of ESG on MASH remains unknown.\n\nIn this study, the investigators will compare ESG + lifestyle modification versus lifestyle modification alone in treating histologic MASH. The study will randomize patients to one of two different treatment options: ESG + lifestyle modification or lifestyle modification alone.",[107,108,30,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124],"Obesity","Liver Diseases","Liver Fat","Metabolic Dysfunction-Associated Steatotic Liver Disease","Metabolic Dysfunction-Associated Steatohepatitis","MASLD","MASH","Weight Loss","Insulin Resistance","Insulin Sensitivity","Insulin Sensitivity\u002FResistance","Metabolic Disease","Diabetes","Diabetes Mellitus, Type 2","NASH With Fibrosis","Non-Alcoholic Fatty Liver Disease","Non Alcoholic Fatty Liver","Non-alcoholic Steatohepatitis",[126,127,128,129,130,131,132,133,134,135,136,137,138],"Gut Hormones","Endoscopic Bariatric and Metabolic Therapy (EBMT)","Intragastric Balloon (IGB)","Endoscopic Suturing","Endoscopic Sleeve Gastroplasty (ESG)","Weight Management","Endoscopic Gastric Remodeling (EGR)","Endoscopic Bariatric Therapy (EBT)","Fatty Liver","Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)","Metabolic Dysfunction-Associated Steatohepatitis (MASH)","Non-Alcoholic Fatty Liver Disease (NAFLD)","Non-Alcoholic Steatohepatitis (NASH)",{"date":61,"type":35},{"date":141,"type":35},"2025-06-24",{"date":143,"type":22},"2028-06",{"name":145,"class":146},"Pichamol Jirapinyo, MD, MPH","OTHER",2,{"id":149,"slug":150,"hasResults":12,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":12,"sex":17,"minAge":156,"maxAge":157,"enrollmentInfo":158,"targetDuration":160,"studyType":161,"phases":4,"briefSummary":162,"conditions":163,"keywords":167,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":187},"100641243","automated-passive-case-finding-for-advanced-liver-fibrosis-in-masld-the-liverseek-programme-100641243","NCT07658755","Automated Passive Case-Finding for Advanced Liver Fibrosis in MASLD: The LiverSeek Programme","Towards Universal Screening for Metabolic Dysfunction-Associated Liver Fibrosis in Primary Care: Evaluation of a Single-Step, Laboratory Informatión System-Driven Automated Case-Finding Strategy (LiverSeek)","LiverSeek","Inclusion Criteria:\n\n1. Age between 50 and 75 years (inclusive)\n2. Routine blood test processed in the Clinical Biochemistry Laboratory of Hospital General Universitario Gregorio Marañón, ordered by a primary care physician in one of the 11 affiliated SERMAS primary care centres\n3. Presence of at least one of the following metabolic risk factor combinations:\n\n   * ALT above the upper limit of normal AND HbA1c ≥6.5%\n   * ALT above the upper limit of normal AND BMI \\>30 kg\u002Fm²\n   * BMI \\>30 kg\u002Fm² AND HbA1c ≥6.5%\n\nExclusion Criteria:\n\n1. Age \\\u003C50 years or \\>75 years\n2. Known pre-existing liver disease (significant or advanced fibrosis, cirrhosis, hepatocellular carcinoma, prior liver transplantation)\n3. Prior fibrosis assessment within the preceding 12 months.","50 Years","75 Years",{"count":159,"type":22},3000,"24 Months","OBSERVATIONAL","LiverSeek is a fully automated, passive case-finding programme for advanced liver fibrosis associated with metabolic dysfunction-associated steatotic liver disease (MASLD) in primary care. The programme operates through the Laboratory Information System (LIS; Modulab\u002FBiwer Analytics) of the Clinical Biochemistry Laboratory at Hospital General Universitario Gregorio Marañón (HGUGM), covering approximately 350,000 inhabitants across 11 peri-urban primary care centres affiliated to SERMAS (Servicio Madrileño de Salud) in Madrid, Spain.\n\nWhen a high-risk patient (age 50-75 years with ≥1 of: ALT above ULN + HbA1c ≥6.5%; ALT above ULN + BMI \\>30; BMI \\>30 + HbA1c ≥6.5%) undergoes a routine blood test in primary care, the LIS automatically calculates FIB-4. If FIB-4 \\>1.30, the system reflexively orders ELF and MASEF from the same serum sample, without any action required from the primary care clinician. Patients with a positive second-step NIT (ELF ≥9.8 or MASEF ≥0.33) receive an automatic alert directing them to the Hepatology Advanced Practice Nurse for VCTE (FibroScan) and clinical evaluation.\n\nThe primary objective is to evaluate the prevalence of hepatic fibrosis in the high-risk population using this single-step automated strategy. Secondary objectives include head-to-head diagnostic comparison of FIB-4+ELF vs FIB-4+MASEF vs FIB-4+FAST for histologically-confirmed endpoints (significant fibrosis ≥F2, advanced fibrosis ≥F3, at-risk MASH), evaluation of the Liver Risk Score, and a health-economic analysis. A sub-study evaluates a nurse-led structured lifestyle intervention in NIT-positive patients.",[110,30,164,165,107,166],"Non-alcoholic Fatty Liver Disease NAFLD","Type 2 Diabetes Mellitus","Obesity Type 2 Diabetes Mellitus",[112,168,169,170,171,172,173,174,175,176,177],"MAFLD","NAFLD","liver fibrosis","FIB-4","ELF","MASEF","screening","passive screening","advanced practice nurse","lifestyle intervention","2026-06-14",{"date":180,"type":35},"2026-06-22",{"date":182,"type":35},"2024-10-01",{"date":184,"type":22},"2027-09-01",{"name":186,"class":146},"Hospital General Universitario Gregorio Marañon",1,{"id":189,"slug":190,"hasResults":12,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":194,"eligibilityCriteria":195,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":19,"enrollmentInfo":196,"targetDuration":198,"studyType":161,"phases":4,"briefSummary":199,"conditions":200,"keywords":202,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":187},"100639234","correlation-of-eus-swq-and-liver-fibrosis-pathology-in-chronic-liver-disease-100639234","NCT07588854","Correlation Of EUS-SWQ And Liver Fibrosis Pathology In Chronic Liver Disease","EU-ME3 Endoscopic Ultrasound Shear Wave Quantification (EUS-SWQ) for Evaluating Liver Fibrosis and Histopathology in Patients With Chronic Liver Disease","EUS-SWQ-202601","Inclusion Criteria:\n\n1. Age ≥ 18 years and ≤ 80 years.\n2. Patients with clinical indications scheduled to undergo liver biopsy (EUS-guided) for the evaluation of liver lesions. Chronic liver disease meeting criteria for biopsy includes:Hepatitis B；Fatty liver disease；Autoimmune hepatitis；Other chronic liver diseases of unknown etiology that would benefit from liver biopsy\n3. Planned to undergo EUS-SWQ and FibroScan examinations prior to biopsy.\n4. Willing to provide and sign written informed consent.\n\nExclusion Criteria:\n\n1. Patients unable to tolerate endoscopic procedures.\n2. Patients with contraindications to endoscopy or anesthesia.\n3. Coagulopathy (platelet count \\\u003C 50×10⁹\u002FL, PT \\> upper limit of normal by 3 seconds).\n4. Patients with severe underlying diseases of the respiratory, cardiovascular, cerebrovascular, digestive, or hematologic systems, as well as those with psychiatric disorders.\n5. Patients with surgically altered anatomy that precludes adequate EUS imaging of the hepatic parenchyma.\n6. Patients with imaging findings suggestive of malignant liver tumors.\n7. Pregnant or lactating women.\n8. Patients with decompensated cirrhosis (gastrointestinal bleeding, ascites, encephalopathy).\n9. Patients who refuse to participate in the clinical study.\n10. Any other conditions deemed inappropriate by the investigator.",{"count":197,"type":22},65,"2 Weeks","The goal of this clinical study is to learn whether the Olympus EU-ME3 endoscopic ultrasound shear wave quantification (EUS-SWQ) function can accurately diagnose and grade liver fibrosis in patients with chronic liver disease. It will also learn about the safety and measurement success rate of EUS-SWQ.\n\nThe main questions it aims to answer are:\n\nHow closely do EUS-SWQ measurements match liver fibrosis stages determined by liver biopsy (the reference standard)? Does EUS-SWQ correlate better with liver biopsy results than FibroScan? How safe is EUS-SWQ and how often can successful measurements be obtained? Researchers will compare EUS-SWQ results with liver biopsy pathology (METAVIR F0-F4) and with FibroScan results to evaluate its diagnostic value.\n\nParticipants will:\n\nBe adults with chronic liver disease who are scheduled to undergo a clinically indicated liver biopsy Undergo an EUS-SWQ examination as part of the study Have their liver stiffness measured by both EUS-SWQ and FibroScan for comparison Be monitored for any discomfort or adverse events related to the procedures A total of 65 participants will take part in this prospective, single-center, post-market clinical study.",[201,30],"Chronic Liver Disease (CLD)",[203,204,205,206,207,208,209],"Chronic liver disease","Liver fibrosis","EUS-SWQ","Endoscopic ultrasound","Liver biopsy","FibroScan","Olympus EU-ME3","2026-05-13",{"date":212,"type":35},"2026-05-15",{"date":214,"type":22},"2026-05",{"date":216,"type":22},"2028-01",{"name":218,"class":146},"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine",{"id":220,"slug":221,"hasResults":12,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":4,"eligibilityCriteria":225,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":19,"enrollmentInfo":226,"targetDuration":4,"studyType":23,"phases":228,"briefSummary":229,"conditions":230,"keywords":4,"overallStatus":232,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":187},"100640330","sonazoid-ceus-for-early-hcc-surveillance-100640330","NCT07590284","Sonazoid CEUS for Early HCC Surveillance","A Multicenter, Prospective Study of Sonazoid CEUS for Early HCC Surveillance in a High-risk Population","Inclusion Criteria:\n\n1. Cirrhotic patients diagnosed clinically or radiologically due to any etiology (patients with cirrhosis due to congenital fibrosis and patients with cirrhosis due to vascular causes were excluded).\n2. Age 18-80 years old.\n3. Able to receive regular imaging, including US, CEUS, and CECT or CEMRI or EOB-MRI, according to the diagnostic and treatment procedures.\n4. Obtained informed consent from the patient.\n\nExclusion Criteria:\n\n1. Patients with pathologic or enhanced imaging of established HCC who have not undergone curative treatment.\n2. Patients with known hypersensitivity to enhanced imaging contrast agents.\n3. Patients with severe cardiac, pulmonary or renal insufficiency that precludes CECT or CEMRI or EOB-MRI.\n4. Lactating and pregnant women.\n5. Those who are not suitable for enrollment as assessed by the investigator.\n6. Patients with egg or egg-product allergy, or with severe right-to-left cardiac shunt or intrapulmonary shunt.",{"count":227,"type":22},556,[25],"This study is a multicenter, prospective study. In this study, enrolled subjects are cirrhotic patients of any etiology. The US and Sonazoid CEUS monitoring strategy was performed for cirrhotic patients: US and AFP joint with Sonazoid CEUS every 4 to 6 months, and combined CECT\u002FCEMRI every 12 months.",[231,30],"Liver Cirrhosis","NOT_YET_RECRUITING","2026-05-11",{"date":212,"type":35},{"date":236,"type":22},"2026-05-30",{"date":238,"type":22},"2029-12-30",{"name":240,"class":146},"Tianjin Third Central Hospital",{"id":242,"slug":243,"hasResults":12,"nctId":244,"briefTitle":245,"officialTitle":245,"acronym":4,"eligibilityCriteria":246,"healthyVolunteers":247,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":248,"targetDuration":250,"studyType":161,"phases":4,"briefSummary":251,"conditions":252,"keywords":255,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":187},"100613358","single-cell-multiomics-and-spatiotemporal-omics-analyze-the-mechanism-of-liver-degenerative-disease-100613358","NCT07265544","Single-cell Multiomics and Spatiotemporal Omics Analyze the Mechanism of Liver Degenerative Disease","Inclusion Criteria:\n\n1. Voluntarily signed the informed consent form;\n2. No restrictions on age and gender;\n3. Patients diagnosed with hepatic hemangioma or focal nodular hyperplasia of the liver in accordance with the \"Guidelines for the Diagnosis and Treatment of Focal Liver Lesions (2014 Edition)\" and the \"Guidelines for the Diagnosis and Treatment of Hemangiomas and Vascular Malformations (2019 Edition)\";\n4. Patients with hepatic hemangioma, focal nodular hyperplasia of the liver, fatty liver, HBV infection, liver fibrosis, and cirrhosis who clinically require liver surgery or liver biopsy.\n\nExclusion Criteria:\n\n1. Individuals with concurrent infections such as HIV will be excluded.\n2. Patients with coagulation system disorders, such as hemophilia or idiopathic thrombocytopenic purpura, will not be included.\n3. Those with severe underlying diseases that affect the body's immune status will be excluded.\n4. Individuals whom the investigator deems unsuitable for participation in this study will be excluded.",true,{"count":249,"type":22},240,"7 Days","The purpose of this observational study is to employ single-cell multi-omics and spatial omics technologies to characterize the spatial and immune structures within the livers of patients with fatty liver, hepatic hemangioma, focal nodular hyperplasia, liver fibrosis, cirrhosis, and HBV infection. The primary questions it aims to address are:\n\nInvestigate the mechanisms of liver degenerative changes during the processes of liver aging, fatty liver, HBV infection, liver fibrosis, and cirrhosis.\n\nCharacterize the molecular features and cellular networks at different stages of liver degeneration and identify new targets and mechanisms for the cure of the aforementioned diseases.\n\nThe study will collect peripheral blood and discarded liver tissue from patients with hepatic hemangioma, fatty liver, HBV infection, liver fibrosis, and cirrhosis who are undergoing hepatectomy or liver biopsy.",[253,254,164,30],"Liver Neoplasm","HBV Infection",[256,257,258],"single-cell multi-omics","HBV infection","liver degenerative changes","2026-04-13",{"date":261,"type":35},"2026-04-14",{"date":263,"type":35},"2023-03-01",{"date":265,"type":22},"2027-02-12",{"name":267,"class":146},"Nanfang Hospital, Southern Medical University",{"id":269,"slug":270,"hasResults":12,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":274,"eligibilityCriteria":275,"healthyVolunteers":247,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":276,"targetDuration":278,"studyType":161,"phases":4,"briefSummary":279,"conditions":280,"keywords":281,"overallStatus":232,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":187},"100633725","samsung-s-viscosity-vs-canon-dispersion-slope-in-steatotic-liver-disease-savid-sld-100633725","NCT07530419","Samsung S-Viscosity vs Canon Dispersion Slope in Steatotic Liver Disease (SAVID-SLD)","Prospective Evaluation of Samsung Medison 2D Shear Wave Elastography Viscoelasticity Parameters in Patients With Steatotic Liver Disease Using Canon Dispersion Slope Imaging as Reference Standard: A Single-Center Non-Interventional Observational Study","SAVID-SLD","Inclusion Criteria:\n\n* \\[Cohort A - Healthy reference\\]\n\n  * Adults ≥18 years old\n  * Currently undergoing living-donor evaluation at SNUH\n  * Donor evaluation confirms (a) hepatic steatosis \\\u003C5% by imaging or biopsy, (b) normal AST\u002FALT, and (c) absence of chronic liver disease (HBV, HCV, autoimmune, cholestatic, etc.)\n  * Provided written informed consent \\[Cohort B + C - Steatotic liver disease\\]\n  * Adults ≥18 years old\n  * Sonographically suspected or confirmed hepatic steatosis on B-mode ultrasound, scheduled for clinical abdominal ultrasound\n  * Serum AST\u002FALT results available within 6 weeks of ultrasound, or scheduled\n  * Provided written informed consent\n\nExclusion Criteria:\n\n* • Significant alcohol intake within the past 2 years (\\>30-60 g\u002Fday for males, \\>20-50 g\u002Fday for females)\n\n  * Diagnosed or strongly suspected chronic liver disease (active HBV\u002FHCV, autoimmune liver disease, cholestatic liver disease, Wilson's disease, hemochromatosis, etc.)\n  * Suspected hepatic failure or decompensated cirrhosis (albumin \\\u003C3.2 g\u002FdL, INR \\>1.3, direct bilirubin \\>1.3 mg\u002FdL)\n  * Ascites, history of variceal bleeding, or acute biliary obstruction rendering stable measurements unfeasible\n  * History of liver malignancy or treatment for liver malignancy\n  * History of liver surgery\n  * Pregnancy or lactation\n  * Inadequate ultrasound image quality due to obesity, bowel gas, or patient inability to cooperate",{"count":277,"type":22},95,"1 Week","Steatotic liver disease (SLD) is one of the most common chronic liver diseases worldwide. Distinguishing simple steatosis from metabolic dysfunction-associated steatohepatitis (MASH) with significant fibrosis is clinically important, but liver biopsy - the current standard - is invasive. Recent ultrasound technology allows noninvasive measurement of tissue viscoelasticity, which has been linked to liver inflammation. Samsung Medison's HERA W12 system (S-Viscosity) and Canon Aplio i800 (Dispersion Slope Imaging) both provide vendor-specific viscoelasticity parameters derived from shear-wave dispersion analysis, but their relationship and agreement have not been compared in SLD patients.\n\nThis prospective single-center observational study will enroll approximately 95-100 participants in three cohorts: (A) 15-20 living-donor candidates as a healthy reference, (B+C) approximately 80 adults with sonographically suspected or confirmed SLD recruited consecutively. SLD participants will be classified post-hoc into low-MASH-risk (Cohort B) and at-risk MASH (Cohort C) subgroups using a multi-parametric stratification combining liver stiffness (LSM), DeepUSFF (deep-learning-based ultrasound fat fraction), and serum AST. All participants will undergo same-day ultrasound examination with both Samsung HERA W12 and Canon Aplio i800. The primary objective is to evaluate the correlation and agreement between Samsung S-Viscosity and Canon Dispersion Slope. Secondary objectives include deriving a normal reference range from the healthy cohort, comparing viscoelasticity parameters across cohorts, and exploring a Modified US-FAST score.",[110,134,30],[282,283,284,285,286,112,113,287],"Shear wave elastography","Viscoelasticity","Dispersion slope","Liver stiffness","Quantitative ultrasound","S-Viscosity","2026-04-08",{"date":290,"type":35},"2026-04-15",{"date":292,"type":22},"2026-04-10",{"date":294,"type":22},"2027-02-28",{"name":296,"class":146},"Seoul National University Hospital",{"id":298,"slug":299,"hasResults":12,"nctId":300,"briefTitle":301,"officialTitle":302,"acronym":4,"eligibilityCriteria":303,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":304,"enrollmentInfo":305,"targetDuration":307,"studyType":161,"phases":4,"briefSummary":308,"conditions":309,"keywords":4,"overallStatus":232,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":187},"100632456","the-correlation-between-hs-crp-tg-triglycerides-glucose-index-in-nafld-and-liver-fibrosis-100632456","NCT07513922","The Correlation Between hs CRP TG Triglycerides Glucose Index in NAFLD and Liver Fibrosis","Correlation Between hs CRP TG Triglycerides Glucose Index in NAFLD and Liver Fibrosis","Inclusion Criteria:\n\n1. Adults ≥18 years\n2. Available fasting labs: TG, fasting glucose, hs-CRP\n3. Valid liver assessment by VCTE (FibroScan LSM) and CAP or ultrasound-based steatosis assessment\n\nExclusion Criteria:\n\n* 1- Significant alcohol intake (define using your local standard; commonly sex-specific thresholds) 2- Viral hepatitis (HBsAg positive and\u002For HCV RNA positive) 3- Other chronic liver diseases (autoimmune hepatitis, hemochromatosis, Wilson's, etc.) 4- Pregnancy","85 Years",{"count":306,"type":22},96,"1 Year","The Correlation between hs CRP TG triglycerides Glucose index in NAFLD and liver fibrosis",[30],"2026-03-31",{"date":312,"type":35},"2026-04-07",{"date":314,"type":22},"2026-10-02",{"date":316,"type":22},"2027-12-02",{"name":318,"class":146},"Assiut University",{"id":320,"slug":321,"hasResults":12,"nctId":322,"briefTitle":323,"officialTitle":323,"acronym":324,"eligibilityCriteria":325,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":326,"targetDuration":328,"studyType":161,"phases":4,"briefSummary":329,"conditions":330,"keywords":335,"overallStatus":232,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":4},"100629537","prevalence-and-risk-factors-of-metabolic-associated-hepatic-steatosis-in-individuals-living-with-type-1-diabetes-100629537","NCT07475962","Prevalence and Risk Factors of Metabolic-Associated Hepatic Steatosis in Individuals Living With Type 1 Diabetes","STEA-DT1","Inclusion Criteria:\n\n* Individuals ≥ 18 years of age.\n* A clinical diagnosis of type 1 diabetes or Latent Autoimmune Diabetes in Adults (LADA) for at least one year, as per the investigators' clinical judgment (confirmatory C-peptide and antibodies will not be required).\n\nExclusion Criteria:\n\n* Alcohol consumption exceeding 20g per day in women or 30g per day in men.\n* Known chronic liver disease (including viral, drug-induced, Wilson disease, deficit in alpha-1-antirypsin, hemochromatosis, autoimmune hepatitis, etc.).\n* Evidence of cirrhosis based on a result of liver biopsy, or history of portal hypertension presented by ascites, hepatic encephalopathy or varices.\n* History of use of medications known to induce liver steatosis, including corticosteroids, high-dose estrogens, tamoxifen, methotrexate, amiodarone, or tetracycline.\n* Ongoing pregnancy.\n* Life expectancy of less than 5 years, as per investigators' clinical judgment.",{"count":327,"type":22},100,"3 Days","The goal of this observational cross-sectional study is to assess the prevalence and stage of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), specifically liver steatosis and fibrosis in adults aged 18 and older living with type 1 diabetes or Latent Autoimmune Diabetes in Adults (LADA) in Quebec.\n\nThe main questions it aims to answer are:\n\n1. What is the prevalence and severity of liver steatosis and fibrosis among people living with type 1 diabetes in Québec?\n2. Are there patients with type 1 diabetes who have advanced, undiagnosed stages of liver disease that require management but are missed by current standard care practices?\n\nResearchers will compare three participant subgroups based on adiposity (a control group without increased adiposity, an overweight group with increased adiposity, and an obesity group with increased adiposity) to see if the prevalence and severity of hepatic steatosis and fibrosis are highest in the obesity group and lowest in the control group. They will also explore if variables and potential risk factors associated with liver disease differ across these subgroups.\n\nParticipants will attend a single study visit where they will be asked to:\n\n* Provide clinical data through laboratory analyses.\n* Undergo specific clinical procedures.\n* Complete validated questionnaires.",[331,332,333,30,334],"Type 1 Diabetes","Liver Steatoses","MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease","Latent Autoimmune Diabetes in Adult (LADA)",[112,336,204,337,338,339],"Liver steatosis","LADA","Body composition","Type 1 diabetes","2026-03-19",{"date":342,"type":35},"2026-03-23",{"date":344,"type":22},"2026-04-01",{"date":346,"type":22},"2027-05-30",{"name":348,"class":146},"Institut de Recherches Cliniques de Montreal",{"id":350,"slug":351,"hasResults":12,"nctId":352,"briefTitle":353,"officialTitle":354,"acronym":4,"eligibilityCriteria":355,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":356,"targetDuration":4,"studyType":161,"phases":4,"briefSummary":358,"conditions":359,"keywords":360,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":365,"startDateStruct":366,"completionDateStruct":368,"leadSponsor":370,"locationsCount":187},"100395438","rapid-breath-hold-quantitative-macromolecular-proton-fraction-imaging-for-liver-fibrosis-100395438","NCT04429100","Rapid Breath-hold Quantitative Macromolecular Proton Fraction Imaging for Liver Fibrosis","Assessment of Fibrosis by Non-invasive Quantitative Imaging of Collagen in the Liver Using Breath-hold MRI With Comparison With MR Elastography and Liver Biopsy","Inclusion Criteria:\n\n1. Patient group\n\n   * patients with histology-proven liver fibrosis, including those with liver fibrosis stage F0, early-stage liver fibrosis (F1-2), and late stage.\n\n   liver fibrosis(F3-4).\n   * patient aged 18 years old and above.\n2. Healthy control group\n\n   * controls aged 18 years old and above.\n\nExclusion Criteria:\n\n* Contraindications to MRI, such as cardiac pacemaker, claustrophobia, pregnancy, metallic implants not suitable for MRI scan.",{"count":357,"type":22},200,"Chronic liver disease is a major health problem worldwide. Liver fibrosis is a key feature in most chronic liver diseases. When identified early, liver fibrosis may be reversible. Currently, liver biopsy is the gold standard for the diagnosis of liver fibrosis. Liver biopsy; however, is invasive. Non-invasive diagnostic tools are increasingly used in clinical practice. However, the existing noninvasive methods still have significant limitations to detect early-stage liver fibrosis.\n\nLiver fibrosis is characterized by excessive deposition of collagen-rich connective tissues in the liver. The macromolecular proton fraction (MPF) is an MRI parameter which characterizes the magnetization transfer (MT) effect in tissues. Quantitative MPF imaging is non-invasive and can be used to measure collagen deposition in the liver due to the strong MT effect of collagen. It has been reported MPF quantification can be used for diagnosis of early-stage liver fibrosis. However, the existing approaches require B1, B0, and T1 map in addition to the imaging data for MPF quantification, which makes it challenging to adopt them for routine clinical use.\n\nThe investigators propose a fast and robust MPF quantification approach. In contrast to the existing methods which rely on saturation radiofrequency pulses for MPF quantification, our approach is based on spin-lock radiofrequency pulses which have minimum Rabi oscillations. The whole imaging data can be acquired within a breath-hold less than 8 seconds. Our approach only needs a B1 map in addition to the imaging data for MPF quantification. The preliminary clinical studies on 3.0T MRI show the measurement using our approach is specific to collagen content and can be used to detect early-stage liver fibrosis. To further confirm the clinical value of the proposed approach, the investigators will investigate the relationship of the collagen content measured using the proposed non-invasive imaging approach and those measured based on morphometry analysis of histology, and determine the diagnostic value of the proposed method for detection of early stage liver fibrosis in a large cohort. The investigators will also perform comparative studies of the proposed method and the state-of-the-art quantitative MPF imaging technique.\n\nThis project will provide a diagnostic technology for early detection of liver fibrosis. The proposed MRI technology also has potential to be used for other clinical purposes.",[30],[361,362,363],"magnetic resonance imaging","quantitative imaging","spin-lock","2026-03-18",{"date":340,"type":35},{"date":367,"type":35},"2020-03-01",{"date":369,"type":22},"2027-12-30",{"name":371,"class":146},"Chinese University of Hong Kong",{"id":373,"slug":374,"hasResults":12,"nctId":375,"briefTitle":376,"officialTitle":376,"acronym":377,"eligibilityCriteria":378,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":379,"targetDuration":4,"studyType":161,"phases":4,"briefSummary":381,"conditions":382,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":383,"lastUpdatePostDateStruct":384,"startDateStruct":386,"completionDateStruct":388,"leadSponsor":390,"locationsCount":147},"100595333","city-hospital-collaboration-for-early-detection-of-liver-fibrosis-in-primary-care-a-secondary-prevention-project-in-the-grenoble-health-area-100595333","NCT07031089","City-Hospital Collaboration for Early Detection of Liver Fibrosis in Primary Care: A Secondary Prevention Project in the Grenoble Health Area","PREFIB","Inclusion Criteria:\n\n* Patients aged 18 years or older\n* Having undergone a Fibroscan® at the CHU de Grenoble-Alpes or CPTS-SEG, requested by a primary care practitioner (general practitioner, non-hospital diabetologist, Asalée nurse), as part of the screening recommendations for liver fibrosis in the case of a FIB4 score \\> 1.3\n* With a result ≥ 8kPa\n* Between January 2023 and January 2026\n\nExclusion Criteria:\n\n* Patients who have expressed their opposition to participating in the study\n* Patients under guardianship or deprived of liberty\n* Patients with a known chronic liver disease who are being monitored at the time of the Fibroscan® procedure",{"count":380,"type":22},150,"Cirrhosis and hepatocellular carcinoma (HCC) are responsible for 25,000 deaths per year in France. The main causes are excessive alcohol consumption, metabolic steatosis, and hepatitis B and C. Fibrosis, classified from F0 (absence of fibrosis) to F4 (cirrhosis), is the sole determinant of liver-related mortality, particularly from stage F3. The incidence of metabolic steatosis is increasing, associated with a rise in mortality from chronic liver diseases (CLD). CLDs, often asymptomatic, are diagnosed late, reducing patient survival. Recommendations exist for the screening of hepatic fibrosis in at-risk patients (alcohol, diabetes, metabolic syndrome). This screening relies on calculating the FIB-4 score (calculated from widely prescribed variables: AST, ALT, platelets, age), followed by Fibroscan® (a non-invasive test for hepatic fibrosis) if FIB-4 \\> 1.3.\n\nA Fibroscan® result \\\u003C8kPa excludes advanced fibrosis, while a result \\>9.6kPa suggests advanced fibrosis and ≥15kPa indicates cirrhosis. The appropriate care pathway includes a risk reduction program, a specialized consultation for patients with Fibroscan® ≥8kPa, and semi-annual screening for HCC in the case of cirrhosis. Indeed, it has been shown in a French cohort of patients with viral C cirrhosis that adherence to semi-annual screening is associated with better survival.\n\nEligible patients are primarily seen in primary care, and INCA has published a recommendation intended for general practitioners to improve the screening of fibrosis \\[13\\]. However, FIB-4 is poorly known among general practitioners \\[14\\], and access to Fibroscan® remains limited \\[15\\], hindering the implementation of the recommendations. Therefore, a care pathway has been established in the Grenoble area, initiated by Professor Costentin, allowing access to Fibroscan® for patients in primary care, starting from 2022 at the CHU. The objective is to evaluate the completion of the pathway, particularly the management of MCF risk factors and referral to specialized consultation for patients with Fibroscan® ≥8 kPa.",[30],"2026-02-26",{"date":385,"type":35},"2026-03-02",{"date":387,"type":35},"2026-01-14",{"date":389,"type":22},"2029-01-14",{"name":391,"class":146},"University Hospital, Grenoble",{"id":393,"slug":394,"hasResults":12,"nctId":395,"briefTitle":396,"officialTitle":397,"acronym":4,"eligibilityCriteria":398,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":19,"enrollmentInfo":399,"targetDuration":401,"studyType":161,"phases":4,"briefSummary":402,"conditions":403,"keywords":405,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":383,"lastUpdatePostDateStruct":408,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":414,"locationsCount":187},"100575959","mr-elastography-for-assessing-liver-fibrosis-in-chronic-hepatitis-b-100575959","NCT06779058","MR Elastography for Assessing Liver Fibrosis in Chronic Hepatitis B","Retrospective and Prospective Multi-center Clinical Study of Magnetic Resonance Elastography in Evaluating Hepatic Fibrosis in Chronic Viral Hepatitis B","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Confirmed CHB (laboratory, imaging and clinical tests)\n* MRE within 6 months before and after liver biopsy\n* Treatment-naïve\n* Child-Pugh Grade A (\\\u003C7 points)\n* Written informed consent in prospective follow-up cohort\n\nExclusion Criteria:\n\n* Patients with liver malignant tumor\n* Chronic hepatitis due to other causes (such as alcoholic hepatitis)\n* CHB combined with hepatitis C, hepatitis D, or HIV\n* Patients with biliary tract diseases\n* Contraindications of MRE examination, MRE failure\n* Poor pathological effect",{"count":400,"type":22},600,"2 Years","How to construct a non-invasive, accurate, and convenient method to evaluate the severity of liver fibrosis (LF) is an important general problem in the management of patients with chronic hepatitis B (CHB). We plan to investigate the ability of magnetic resonance elastography (MRE) to grade fibrosis in chronic hepatitis B and apply to clinical longitudinal follow-up.",[404,30],"Chronic Hepatitis B",[406,285,407],"Magnetic resonance elastography","Antiviral therapy",{"date":409,"type":35},"2026-02-27",{"date":411,"type":35},"2025-01-01",{"date":413,"type":22},"2026-12-01",{"name":415,"class":146},"Shengjing Hospital",{"id":417,"slug":418,"hasResults":12,"nctId":419,"briefTitle":420,"officialTitle":421,"acronym":4,"eligibilityCriteria":422,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":157,"enrollmentInfo":423,"targetDuration":4,"studyType":23,"phases":425,"briefSummary":426,"conditions":427,"keywords":429,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":434,"lastUpdatePostDateStruct":435,"startDateStruct":437,"completionDateStruct":439,"leadSponsor":441,"locationsCount":187},"100479681","phase-2-thyroid-hormone-for-treatment-of-nonalcoholic-steatohepatitis-in-veterans-100479681","NCT05526144","Thyroid Hormone for Treatment of Nonalcoholic Steatohepatitis in Veterans","Low Dose Thyroid Hormone, Mitochondrial Fatty Acid Oxidation, and Treatment of Nonalcoholic Steatohepatitis (NASH)","Inclusion Criteria:\n\n* Men and women (pre- and post-menopausal)\n* Overweight\u002Fobese subjects with body mass index (BMI) at or above 25.9 kg\u002Fm2\n* Alcohol intake \\\u003C 20 grams per day\n* Patients with type 2 diabetes on stable doses of antidiabetic medication for at least 3 months before enrollment\n* Patients who are treated with vitamin E or pioglitazone should be on stable doses for at least 6 months before enrollment\n* Features of metabolic syndrome: 3 or more (central obesity, hypertension, low HDL, high triglycerides, high fasting glucose)\n* Scheduled for a medically indicated, diagnostic liver biopsy\n* Female patients are eligible if they are of reproductive potential and have a negative serum pregnancy test (beta human chorionic gonadotropin), are not breastfeeding, and do not plan to become pregnant during the study and agree to use two highly effective birth control methods during the study OR if they are not of child-bearing potential (i.e., surgically \\[bilateral oophorectomy, hysterectomy, or tubal ligation\\] or naturally sterile \\[\\> 12 consecutive months without menses\\])\n\n  * Highly effective birth control methods include condoms with spermicide, diaphragm with spermicide, hormonal and nonhormonal intrauterine device, hormonal contraception (estrogens stable for at least 3 months), a vasectomized male partner, or sexual abstinence (defined as refraining from heterosexual intercourse), from screening, throughout the study, and for at least 30 days after the last dose of study drug administration\n  * Reliance on abstinence from heterosexual intercourse is acceptable only if it is the patient's habitual practice\n* If a patient is on digitalis and amiodarone, he\u002Fshe is expected to use\u002Fcontinue these medications throughout the treatment period only after consultation with their cardiologist for monitoring and dose adjustments if necessary\n\nExclusion Criteria:\n\n* Other causes of hepatitis including hepatitis B \\& C, autoimmune hepatitis, hemochromatosis, celiac disease, Wilson's disease, alpha-1-antitrypsin deficiency, medication-induced hepatitis\n* Alcohol consumption of 20 g\u002Fd or more\n* Patients with cirrhosis, bilirubin of 1.3 mg\u002FdL or more, and INR of 1.3 or more\n* Evidence of Portal hypertension\n* Pregnancy\n* History of malignant hypertension\n* Uncontrolled hypertension (either treated or untreated) defined as systolic blood pressure \\> 160 mm Hg or a diastolic blood pressure \\> 100 mm Hg at screening\n* New York Heart Association Class III or IV heart failure or known left ventricular ejection fraction \\\u003C 30%\n* Uncontrolled cardiac arrhythmia, including confirmed QT interval corrected using Fridericia's formula (QTcF) \\> 450 msec for males and \\> 470 msec for females at the screening electrocardiogram (ECG) assessment\n* History of myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass graft, or stroke within at least 3 months prior to randomization\n* History of high degree AV block (Mobitz II or complete) in the absence of a pacemaker\n* Patients with uncorrected adrenal insufficiency\n* Patients who are on tricyclic or tetracyclic antidepressants or ketamine, if they are unwilling and\u002For unable to discontinue these medications to allow adequate washout prior to randomization\n* Patients who are on Teduglutide or Midodrine",{"count":424,"type":22},128,[56],"Nonalcoholic steatohepatitis (NASH) is the aggressive form of nonalcoholic fatty liver disease, which is rapidly becoming a worldwide public health problem. It is more common in the military and Veteran population compared to the general US population. NASH may progress to end-stage liver disease and primary liver cancer, and hence there is critical need for effective treatment. The goal of this clinical trial is to test whether low dose thyroid hormone administered to Veterans diagnosed with NASH can be an effective therapy mediated by improvement in breaking down fat in the mitochondria. The study will be conducted in two stages, the first stage is for proof of concept to be followed by interim analysis. If the interim analysis supports the merit for continuing the study, the clinical trial will proceed to stage 2 for continuation. This study will provide new information and strategies for treatment of NASH using low dose thyroid hormone that will be highly relevant and impactful to the health of the Veteran population.",[428,30],"Nonalcoholic Steatohepatitis",[430,431,432,433],"Thyroid hormone","Nonalcoholic fatty liver disease (NAFLD)","Nonalcoholic steatohepatitis (NASH)","Mitochondrial fatty acid oxidation","2026-02-17",{"date":436,"type":35},"2026-02-19",{"date":438,"type":35},"2023-04-01",{"date":440,"type":22},"2029-12-31",{"name":442,"class":443},"VA Office of Research and Development","FED",{"id":445,"slug":446,"hasResults":12,"nctId":447,"briefTitle":448,"officialTitle":449,"acronym":4,"eligibilityCriteria":450,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":451,"enrollmentInfo":452,"targetDuration":4,"studyType":23,"phases":454,"briefSummary":455,"conditions":456,"keywords":458,"overallStatus":232,"whyStopped":4,"lastUpdateSubmitDate":460,"lastUpdatePostDateStruct":461,"startDateStruct":462,"completionDateStruct":464,"leadSponsor":466,"locationsCount":187},"100624638","phase-3-a-phase-iiic-clinical-study-to-evaluate-the-long-term-treatment-of-hydronidone-capsules-for-liver-fibrosis-in-patients-with-chronic-hepatitis-b-100624638","NCT07412236","A Phase IIIc Clinical Study to Evaluate the Long-term Treatment of Hydronidone Capsules for Liver Fibrosis in Patients With Chronic Hepatitis B.","A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase IIIc Clinical Study Evaluating the Long-term Treatment of Hepatic Fibrosis in Chronic Hepatitis B With Hydronidone Capsules.","Inclusion Criteria:\n\n* Age 18 to 65 years (inclusive of 18 and 65 years old at the time of signing the informed consent form), male or female;\n* Documented history of chronic hepatitis B and\u002For positive for hepatitis B surface antigen (HBsAg) for ≥6 months;\n* Treatment-naïve or treatment-experienced patients with chronic hepatitis B, defined as follows:\n\n  1. Treatment-naïve patients must meet all of the following criteria:\n\n     * No prior systemic antiviral therapy (e.g., interferon and\u002For nucleos(t)ide analogues) before randomization;\n     * Positive for HBV DNA;\n     * Liver stiffness measurement (LSM) by transient elastography ≥12.4 kPa for treatment-naïve patients with ALT \\>2 × ULN; or LSM ≥10.6 kPa for treatment-naïve patients with ALT ≤2 × ULN. Subjects whose LSM does not meet the above criteria may still be enrolled if they have liver biopsy evidence (within the past 6 months) confirming liver fibrosis of Ishak score ≥3.\n  2. Treatment-experienced patients must meet all of the following criteria:\n\n     * A history of ≥6 months of continuous nucleos(t)ide analogue therapy for hepatitis B up to randomization, currently receiving monotherapy with a nucleos(t)ide analogue \\[e.g., Tenofovir Alafenamide Fumarate (TAF), Tenofovir Disoproxil Fumarate (TDF), or Entecavir (ETV)\\];\n     * HBV DNA positive or negative is acceptable;\n     * Liver stiffness measurement (LSM) by transient elastography \\>9.0 kPa. Subjects whose LSM does not meet the above criteria may still be enrolled if they have liver biopsy evidence (within the past 6 months) confirming liver fibrosis of Ishak score ≥3.\n* ALT \\\u003C8 × ULN;\n* No use within 3 months prior to randomization of the following Chinese patent medicines that may have antifibrotic effects: Fuzhenghuayu Capsule (Tablet), Anluohuaxian Pill, Compound Biejia Ruangan Tablet, etc.;\n* Subjects (or their sexual partners) have no pregnancy plan during the trial and for 6 months after trial completion, voluntarily agree to use effective physical contraceptive methods, and have no plan to donate sperm or eggs;\n* Subjects have fully understood the nature, significance, potential benefits, possible inconveniences, and potential risks of the trial prior to participation, voluntarily agree to take part in this clinical trial, are able to communicate well with the investigators, agree to comply with all study requirements, and have provided written informed consent.\n\nExclusion Criteria:\n\n* Total bilirubin (TBil) \\>3 × ULN, or 3 × ULN \\\u003C ALT \\\u003C8 × ULN with TBil \\>2 × ULN;\n* Platelet count (PLT) ≤50 × 10⁹\u002FL;\n* Prothrombin activity (PTA) \\\u003C50% or International Normalized Ratio (INR) \\>1.5;\n* Imaging findings suggestive of a space-occupying lesion in the liver indicative of tumor, or alpha-fetoprotein (AFP) \\>100 μg\u002FL even in the absence of specific signs of hepatocellular carcinoma;\n* Patients with decompensated liver cirrhosis (complications including ascites, esophageal and\u002For gastric variceal bleeding, spontaneous bacterial peritonitis, hepatorenal syndrome, hepatopulmonary syndrome, hepatic encephalopathy, portal vein thrombosis, and cirrhotic cardiomyopathy) or with hepatic malignancy;\n* Patients with chronic hepatitis C or non-viral chronic hepatitis (alcoholic, drug-induced, etc., excluding metabolic dysfunction-associated steatotic liver disease (MASLD));\n* History of alcohol abuse or inability to abstain from alcohol recently \\[Note: Alcohol abuse is defined as: ① daily ethanol consumption ≥40 g for males or ≥20 g for females for 5 consecutive years; OR ② history of heavy alcohol consumption (\\>80 g of ethanol per day) within the past 2 weeks. Ethanol (g) = volume of alcoholic beverage consumed (mL) × alcohol by volume (%) × 0.8\\];\n* Patients with severe concurrent cardiovascular, pulmonary, renal, endocrine, neurological, or hematological diseases, or psychiatric disorders;\n* Pregnant and\u002For lactating women;\n* Participation in any other drug clinical trial within the past 3 months;\n* Any condition that, in the investigator's judgment, may affect the subject's ability to provide informed consent or comply with the trial protocol, or participation that may affect the trial results or the subject's own safety.","65 Years",{"count":453,"type":22},1208,[81],"This study is conducted as a randomized, double-blind, placebo-controlled, multicenter clinical trial on a background of entecavir therapy. It aims to evaluate the clinical benefits of Hydronidone Capsules in patients with liver fibrosis due to chronic hepatitis B. The study consists of a Screening\u002FBaseline Period (4 weeks) and a Dosing\u002FObservation Period (planned duration of 5 years, including a 52-week primary treatment phase and a 208-week long-term treatment phase).",[30,457],"Liver Fibrosis in Chronic Hepatitis B",[459],"LIver Fibrosis in Chronic Hepatitis B","2026-02-12",{"date":434,"type":35},{"date":463,"type":22},"2026-01-30",{"date":465,"type":22},"2028-12-30",{"name":467,"class":69},"Beijing Continent Pharmaceutical Co, Ltd.",{"id":469,"slug":470,"hasResults":12,"nctId":471,"briefTitle":472,"officialTitle":473,"acronym":4,"eligibilityCriteria":474,"healthyVolunteers":247,"sex":17,"minAge":52,"maxAge":157,"enrollmentInfo":475,"targetDuration":4,"studyType":23,"phases":477,"briefSummary":479,"conditions":480,"keywords":481,"overallStatus":232,"whyStopped":4,"lastUpdateSubmitDate":484,"lastUpdatePostDateStruct":485,"startDateStruct":486,"completionDateStruct":488,"leadSponsor":490,"locationsCount":187},"100623259","phase-1-study-of-hydroxynidone-capsules-in-patients-with-hepatic-impairment-and-matched-healthy-controls-100623259","NCT07394309","Study of Hydroxynidone Capsules in Patients With Hepatic Impairment and Matched Healthy Controls","A Phase I Pharmacokinetic Study of Hydronidone Capsules in Patients With Varying Degrees of Hepatic Impairment and Normal Hepatic Function.","Inclusion Criteria:\n\n* Participants must meet all of the following criteria to be eligible for enrollment:\n* Participants fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign a written informed consent form, and are able to complete the entire trial process as required by the protocol.\n* Age between 18 and 75 years (inclusive), both males and females.\n* At screening, male participants weigh ≥50 kg, female participants weigh ≥45 kg, and body mass index \\[BMI = weight (kg) \u002F height² (m²)\\] is within the range of 18 to 32 kg\u002Fm² (inclusive).\n* Participants and their partners agree to have no plans for conception or sperm\u002Fegg donation from the signing of the informed consent form until 6 months after the last dose of the investigational drug, and voluntarily agree to use effective contraceptive measures.\n* Participants with hepatic impairment must additionally meet the following inclusion criteria:\n\nParticipants with hepatic impairment due to pre-existing primary liver disease, classified as Child-Pugh Class A (score of 5-6) or Class B (score of 7-9) at screening. They must not have received albumin infusion within 14 days prior to screening and must have a confirmed diagnosis of stable (≥1 month) hepatic impairment based on medical history, physical examination, laboratory tests, or imaging studies.\n\nParticipants have not taken any medication within 1 week prior to screening, or for those requiring long-term treatment for hepatic impairment and\u002For other comorbidities, their medication regimen must have been stable for at least 4 weeks (stability is judged by the investigator, excluding medications prohibited by the protocol).\n\nExclusion Criteria:\n\n* Known history of allergy to any component of the investigational product, drugs of the same class (GLP-1 receptor agonists), or their excipients; or history of allergic constitution (multiple drug and food allergies); or history of allergic diseases (e.g., asthma, urticaria, eczematous dermatitis, etc.).\n* Diagnosis of malignant tumor, or history of malignant tumor within 5 years prior to screening (except for: prior hepatocellular carcinoma surgery with stability ≥2 years; treated non-melanoma skin cancer with no signs of recurrence; and excised cervical intraepithelial neoplasia).\n* Presence of severe infection, trauma, gastrointestinal surgery, or other major surgery within 4 weeks prior to screening.\n* 12-lead electrocardiogram (ECG) abnormalities considered clinically significant by the investigator \\[e.g., tachycardia\u002Fbradycardia requiring medication, II-III degree atrioventricular block, prolonged QTcF interval (male QTcF \\>470 ms, female QTcF \\>480 ms, corrected using Fridericia's formula), or other abnormalities deemed clinically significant by the physician\\].\n* Estimated glomerular filtration rate (eGFR) calculated using the Modification of Diet in Renal Disease (MDRD) formula \\\u003C60 mL\u002Fmin\u002F1.73 m².\n* Planned surgical procedure or hospitalization tendency during the trial period.\n* Positive for HIV antibody (HIV-Ab) or Treponema pallidum (TP) antibody.\n* Use of inducers or inhibitors of drug-metabolizing enzymes (CYP3A4 inducers and inhibitors, detailed list in Appendix 4: Common Drugs that are Inhibitors or Inducers of Drug-Metabolizing Enzymes) within 4 weeks prior to dosing.\n* Use of drugs known to inhibit or induce SULT and UGT enzymes within 7 days prior to investigational drug administration, and inability to discontinue such use.\n* Use of any medication (including herbal medicines, vitamins, health supplements) within 14 days (or 5 half-lives, whichever is longer) prior to dosing, except for stable medications in participants with hepatic impairment.\n* Participation in another clinical trial and receipt of an investigational drug or medical device within 1 month prior to screening, with the last dose date of the previous clinical study as the reference point (if the previous investigational drug has a long half-life, at least 5 half-lives must elapse before dosing in this study).\n* History of blood loss or blood donation ≥400 mL within 3 months prior to dosing, or plans to donate blood within 1 month after the end of this trial.\n* History of smoking or smoking more than 5 cigarettes per day within 3 months prior to screening, or inability to abstain from any tobacco products during the study, or positive nicotine test at baseline.\n* Regular alcohol consumption at present or within 1 month prior to screening, defined as females consuming more than 7 units of alcohol per week or males consuming more than 14 units of alcohol per week (1 unit = 285 mL of beer, or 25 mL of spirits with 40% alcohol, or 100 mL of wine); or positive alcohol breath test at baseline, or inability to abstain from alcohol during the trial.\n* History of drug abuse, or use of soft drugs (e.g., marijuana) within 3 months prior to dosing, or use of hard drugs (e.g., cocaine, amphetamines, phencyclidine, etc.) within 1 year prior to dosing, or positive drug abuse screening at baseline.\n* Consumption of food or beverages containing grapefruit juice\u002Fpomelo juice or methylxanthines (tea, coffee, cola, chocolate, energy drinks) within 48 hours prior to dosing, or consumption of any other substance that may affect drug absorption, distribution, metabolism, or excretion.\n* Intolerance to venipuncture, history of needle phobia, or fainting at the sight of blood.\n* Vaccination within 1 month prior to screening.\n* Women who are pregnant or breastfeeding, or participants with a positive blood pregnancy test.\n* Participants considered by the investigator to have poor compliance or other factors unsuitable for participation in this trial.\n* Supplementary Exclusion Criteria for Participants with Hepatic Impairment (Exclusion if any one of the following criteria is met):\n\nHistory of liver transplantation.\n\nDrug-induced liver injury.\n\nAcute liver injury due to any cause.\n\nCholestatic liver disease.\n\nLiver failure with any of the following complications: uncontrolled infection; grade 3\u002F4 hepatic encephalopathy.\n\nSevere complications of cirrhosis with any of the following: active bleeding from esophageal or gastric varices; severe\u002Fadvanced ascites or pleural effusion requiring paracentesis or drainage and albumin supplementation; hepatorenal syndrome; or any other condition deemed by the investigator as unsuitable for study participation.\n\nParticipants with poorly controlled hypertension (systolic blood pressure \\>160 mmHg and\u002For diastolic blood pressure \\>100 mmHg) or heart rate \\>120 bpm (allow two repeat measurements).\n\nAny history of severe disease other than the primary liver disease itself, or any medical history or clinically significant abnormal laboratory findings considered by the investigator as likely to affect the trial results, including but not limited to history of circulatory, endocrine, neurological, digestive, urinary, hematological, immunological, psychiatric, or metabolic disorders.\n\nAlanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) \\>5 times the upper limit of normal (ULN) at screening.\n\nSupplementary Exclusion Criteria for Participants with Normal Hepatic Function (Exclusion if any one of the following criteria is met):\n\nPositive for anti-hepatitis C virus (HCV) antibody or hepatitis B surface antigen (HBsAg).\n\nHistory of primary disease of vital organs, including but not limited to neurological\u002Fpsychiatric, cardiovascular, gastrointestinal, respiratory, urinary, endocrine, hematological, or immune system diseases, deemed by the investigator as unsuitable for trial participation.\n\nHistory of hepatic impairment, or any screening examination results (including physical examination, vital signs, complete blood count, urinalysis, blood biochemistry, coagulation function, 12-lead ECG, chest X-ray posteroanterior view, abdominal ultrasound, etc.) considered by the investigator as clinically significant abnormalities.\n\nAge not within the range of the mean age of participants with mild\u002Fmoderate hepatic impairment ±10 years, and\u002For BMI not within the range of the mean BMI of participants with mild\u002Fmoderate hepatic impairment ±10%.\n\n-Supplementary Exclusion Criteria for Participants with Normal Hepatic Function (Exclusion if any one of the following criteria is met):\n\nPositive for anti-hepatitis C virus (HCV) antibody or hepatitis B surface antigen (HBsAg).\n\nHistory of primary disease of vital organs, including but not limited to neurological\u002Fpsychiatric, cardiovascular, gastrointestinal, respiratory, urinary, endocrine, hematological, or immune system diseases, deemed by the investigator as unsuitable for trial participation.\n\nHistory of hepatic impairment, or any screening examination results (including physical examination, vital signs, complete blood count, urinalysis, blood biochemistry, coagulation function, 12-lead ECG, chest X-ray posteroanterior view, abdominal ultrasound, etc.) considered by the investigator as clinically significant abnormalities.\n\nAge not within the range of the mean age of participants with mild\u002Fmoderate hepatic impairment ±10 years, and\u002For BMI not within the range of the mean BMI of participants with mild\u002Fmoderate hepatic impairment ±10%.",{"count":476,"type":22},30,[478],"PHASE1","This trial adopts a single-center, single-dose, open-label, non-randomized, parallel-controlled design. It will be conducted in participants with varying degrees of hepatic impairment, as well as in participants with normal hepatic function matched for sex, age, and BMI. The administration method is a single oral dose of 90 mg hydroxynidone capsules under fasting conditions.\n\nParticipants meeting the inclusion criteria with corresponding degrees of hepatic impairment and those with normal hepatic function will be enrolled. Each group will complete the study with 10 participants. Matched participants will be comparable in terms of sex (±1 participant per sex), mean age (±10 years), and mean BMI (±10%).",[30],[482,30,483],"Hydronidone","Patients with hepatic fibrosis due to chronic hepatitis B","2026-02-10",{"date":460,"type":35},{"date":487,"type":22},"2026-02-15",{"date":489,"type":22},"2026-10-30",{"name":467,"class":69},{"id":492,"slug":493,"hasResults":12,"nctId":494,"briefTitle":495,"officialTitle":495,"acronym":496,"eligibilityCriteria":497,"healthyVolunteers":12,"sex":17,"minAge":498,"maxAge":499,"enrollmentInfo":500,"targetDuration":4,"studyType":161,"phases":4,"briefSummary":501,"conditions":502,"keywords":503,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":506,"lastUpdatePostDateStruct":507,"startDateStruct":509,"completionDateStruct":511,"leadSponsor":513,"locationsCount":187},"100616248","non-invasive-assessment-of-liver-fibrosis-in-a-french-cohort-of-pediatric-patients-with-type-iii-glycogen-storage-disease-current-state-and-perspectives-100616248","NCT07303140","Non-invasive Assessment of Liver Fibrosis in a French Cohort of Pediatric Patients With Type III Glycogen Storage Disease: Current State and Perspectives","HEPAGLY","Inclusion Criteria:\n\n* Minors: from birth to 17 years\n* Adults: 18 to 21 years\n* Subjects being monitored for type III glycogen storage disease and having had at least one liver elastography measurement during their follow-up.\n\nExclusion Criteria:\n\n\\- Patients monitored for type III glycogen storage disease but who had never undergone liver elastography during their follow-up.","1 Month","21 Years",{"count":476,"type":22},"Patients with type III glycogen storage disease (GSDIII) can develop liver fibrosis, which can be complicated by liver failure or even hepatocellular carcinoma. Since the beginning of the 21st century, non-invasive techniques for assessing fibrosis, such as liver elastography, have been developed. These techniques often make it possible to avoid liver biopsies during patient follow-up and have already been validated in the management of several diseases in adults. These techniques are also beginning to be recommended for monitoring certain chronic liver diseases in children.",[30],[204,504,505],"Type III glycogen storage disease","Liver fibrosis in pediatric patients","2025-12-11",{"date":508,"type":35},"2025-12-24",{"date":510,"type":35},"2024-10-18",{"date":512,"type":22},"2026-02",{"name":514,"class":146},"University Hospital, Strasbourg, France",{"id":516,"slug":517,"hasResults":12,"nctId":518,"briefTitle":519,"officialTitle":520,"acronym":4,"eligibilityCriteria":521,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":157,"enrollmentInfo":522,"targetDuration":4,"studyType":23,"phases":524,"briefSummary":525,"conditions":526,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":527,"lastUpdatePostDateStruct":528,"startDateStruct":530,"completionDateStruct":532,"leadSponsor":534,"locationsCount":187},"100613821","research-on-the-protective-effects-of-phycocyanin-against-liver-fibrosis-and-cirrhosis-100613821","NCT07271576","Research on the Protective Effects of Phycocyanin Against Liver Fibrosis and Cirrhosis","Research on the Role of Phycocyanin in the Prevention, Treatment, and Mechanism of Liver Fibrosis\u002FCirrhosis","Inclusion Criteria:\n\n* Adults between the ages of 18 and 75;\n* Patients diagnosed with liver fibrosis or cirrhosis;\n* Voluntary participation in this study and signing of an informed consent form;\n* No acute diseases or significantly worsening symptoms for at least 4 weeks prior to enrollment.\n\nExclusion Criteria:\n\n* Presence of severe comorbidities;\n* Allergy to phycocyanin;\n* Patients with a history of severe mental illness that may affect treatment compliance.",{"count":523,"type":22},10,[25],"This clinical trial aims to determine whether phycocyanin, a natural protein derived from spirulina, can help treat liver fibrosis or cirrhosis in adult patients. The main questions it aims to answer are:\n\n* Can phycocyanin reduce blood levels of liver enzymes (such as ALT and AST) that indicate liver damage?\n* Can phycocyanin improve liver stiffness as measured by ultrasound?\n\nResearchers will compare the phycocyanin intervention group with a control group that receives a placebo (a similar-looking maltodextrin supplement without active ingredients) to explore if phycocyanin is more effective in treating liver fibrosis\u002Fcirrhosis.\n\nParticipants will:\n\n* Take one sachet of either phycocyanin or placebo daily for at least 4 weeks.\n* Attend regular clinic appointments (typically every 2-3 months) for routine monitoring of your liver condition, which will include blood and urine tests.\n* Provide blood and stool samples once before the treatment and once after the 4-week treatment period.\n* Undergo an ultrasound evaluation of liver stiffness.\n\nThe study will last approximately 2 years, and the personal information of all patients will be kept strictly confidential.",[30,231],"2025-12-07",{"date":529,"type":35},"2025-12-09",{"date":531,"type":35},"2025-06-04",{"date":533,"type":22},"2027-06-04",{"name":535,"class":146},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":537,"slug":538,"hasResults":12,"nctId":539,"briefTitle":540,"officialTitle":541,"acronym":4,"eligibilityCriteria":542,"healthyVolunteers":247,"sex":17,"minAge":52,"maxAge":543,"enrollmentInfo":544,"targetDuration":4,"studyType":23,"phases":546,"briefSummary":547,"conditions":548,"keywords":549,"overallStatus":232,"whyStopped":4,"lastUpdateSubmitDate":550,"lastUpdatePostDateStruct":551,"startDateStruct":553,"completionDateStruct":555,"leadSponsor":557,"locationsCount":187},"100613112","phase-1-the-phase-d-clinical-trial-of-hydronidone-capsules-100613112","NCT07262346","The Phase Ⅰd Clinical Trial of Hydronidone Capsules","Clinical Pharmacokinetic Study of Hydronione Capsules in Healthy Chinese Subjects (Ⅰd)","Inclusion Criteria:\n\n1. Healthy subjects, both male and female;\n2. Age: 18-45 years;\n3. Weight: Male ≥50 kg, Female ≥45 kg, with a BMI between 19 and 26 (BMI = weight (kg)\u002Fheight² (m²));\n4. Pass a comprehensive health examination, meaning no abnormalities or no clinically significant findings in the following: vital signs, physical examination, blood and urine routine tests, blood pregnancy test, blood glucose, blood lipids, blood electrolytes, hepatitis B surface antigen, liver and kidney function, hepatitis C, HIV and syphilis antibody tests, 12-lead electrocardiogram, nicotine screening, urine drug screening, alcohol breath test, chest X-ray, etc.;\n5. Have been fully informed about the nature, significance, potential benefits, possible inconveniences, and risks of the study prior to participation, and voluntarily agree to take part in this clinical trial. Subjects must be able to communicate well with the researchers, comply with all study requirements, and have the capacity to understand and sign the written informed consent form.\n\nExclusion Criteria:\n\n1. (Inquiry) Participation in any other clinical trial within three months prior to this study;\n2. (Inquiry) Presence of any disease that may affect the safety of the trial or the pharmacokinetics of the drug, including but not limited to: past or current diseases of the heart, liver, kidneys, endocrine system, digestive tract, immune system, respiratory system, nervous system, or psychiatric disorders \\[particularly cardiovascular diseases or individuals at risk of cardiovascular diseases, any gastrointestinal diseases affecting drug absorption (e.g., irritable bowel syndrome, inflammatory bowel disease), active pathological bleeding (e.g., peptic ulcer), urticaria, epilepsy, allergic rhinitis, eczematous dermatitis, asthma, active tuberculosis, etc.\\];\n3. (Inquiry) Allergic constitution: such as a history of drug or food allergies, skin allergies, or lactose intolerance;\n4. (Inquiry) Use of any drugs that inhibit or induce hepatic drug metabolism within 28 days before taking the investigational drug (common enzyme inducers: barbiturates such as phenobarbital, carbamazepine, aminoglutethimide, griseofulvin, meprobamate, phenytoin, glutethimide, rifampicin, dexamethasone; common enzyme inhibitors: chlorpromazine, cimetidine, ciprofloxacin, metronidazole, chloramphenicol, isoniazid, sulfonamides);\n5. Use of any medications (including herbal medicines) or health products within 14 days before the first dose;\n6. (Inquiry) Individuals with special dietary requirements who cannot adhere to a standardized diet (e.g., intolerance to standard meals) or those with difficulty swallowing;\n7. (Inquiry) Inability to tolerate venipuncture and\u002For a history of blood or needle phobia;\n8. (Inquiry) Habitual excessive consumption of tea, coffee, or caffeine-containing beverages (more than 8 cups per day, 1 cup = 250 mL); or consumption of any caffeine-containing foods or beverages (e.g., coffee, strong tea, chocolate, etc.) within 48 hours before the first dose, or adherence to any special diet that may affect drug absorption, distribution, metabolism, or excretion;\n9. (Inquiry) History of excessive alcohol consumption (defined as more than 28 standard units per week for men and more than 21 standard units per week for women (1 standard unit contains 14 g of alcohol, equivalent to 360 mL of beer, 45 mL of 40% spirits, or 150 mL of wine)); or regular alcohol consumption (more than 14 standard units per week) within 6 months prior to the trial; or consumption of any alcohol-containing products within 24 hours before the first dose;\n10. (Inquiry) Blood donation or significant blood loss (exceeding 450 mL) within 3 months before the first dose, or plans to donate blood or blood components during the study or within 3 months after its completion;\n11. (Inquiry) Occurrence of an acute illness during the pre-study screening phase or before administration of the study drug;\n12. (Inquiry) Consumption of any foods or beverages known to induce or inhibit hepatic metabolic enzymes (e.g., grapefruit, mango, dragon fruit, grape juice, orange juice, etc., which are rich in flavonoids or citrus glycosides) within 24 hours before the first dose;\n13. (Inquiry) Surgery within three months before screening or plans to undergo surgery during the study period;\n14. (Inquiry) History of drug abuse or substance abuse;\n15. (Inquiry) Smoking more than 5 cigarettes per day within 14 days before screening, or inability to discontinue the use of any tobacco products during the trial period;\n16. (Inquiry) Smoking or use of any tobacco products between screening and hospital admission;\n17. Positive nicotine test result;\n18. Alcohol breath test result greater than 0.0 mg\u002F100 mL;\n19. Positive urine drug screen result;\n20. Pregnant or breastfeeding women;\n21. Individuals planning to conceive within 6 months after the trial or unwilling to use non-pharmacological contraceptive measures;\n22. Any condition deemed by the investigator as potentially affecting the subject's ability to provide informed consent, comply with the trial protocol, or participate in the trial in a way that could impact the results or subject safety.","45 Years",{"count":545,"type":22},138,[478],"Based on the Phase I (Ia, Ib, Ic) clinical pharmacokinetic study of Hydronidone Capsules, a clinical pharmacokinetic trial of Hydronidone Capsules (specification: 30 mg\u002Fcapsule) was conducted, including single-dose administration, multiple-dose administration, and a food-effect study. The aim was to investigate the safety, tolerability, and pharmacokinetic characteristics of higher doses of Hydronidone Capsules (specification: 30 mg\u002Fcapsule) in healthy subjects, in preparation for future expansion of indications.",[30],[482],"2025-11-21",{"date":552,"type":35},"2025-12-03",{"date":554,"type":22},"2025-12-05",{"date":556,"type":22},"2026-05-05",{"name":467,"class":69},{"id":559,"slug":560,"hasResults":12,"nctId":561,"briefTitle":562,"officialTitle":563,"acronym":4,"eligibilityCriteria":564,"healthyVolunteers":247,"sex":17,"minAge":52,"maxAge":451,"enrollmentInfo":565,"targetDuration":4,"studyType":161,"phases":4,"briefSummary":567,"conditions":568,"keywords":4,"overallStatus":232,"whyStopped":4,"lastUpdateSubmitDate":571,"lastUpdatePostDateStruct":572,"startDateStruct":574,"completionDateStruct":576,"leadSponsor":577,"locationsCount":4},"100605901","is-there-a-relationship-between-uric-acid-level-and-liver-fibrosis-in-obese-patients-100605901","NCT07168551","Is There a Relationship Between Uric Acid Level and Liver Fibrosis in Obese Patients","Association of Hyperuricemia and Non Alcoholic Fatty Liver Disease and Liver Fibrosis Risk in Adult Obese Patients","Inclusion Criteria:\n\n1. Age: Adults (typically 18-65 years old)\n\n2 - Body Mass Index (BMI): Obese patients with a BMI ≥ 30 kg\u002Fm²\n\n3- Hyperuricemia : Elevated serum uric acid levels (typically \\> 7 mg\u002FdL for men and \\> 6 mg\u002FdL for women)\n\nExclusion Criteria:\n\n* excessive alcohol consumption ( \\> 20 gm \u002Fday in men and 10 in g \u002Fday in women )\n\n  2- use of steatogenic within the past 6 months\n\n  3- positive test for hepatitis B surface antigen and hepatitis B core antibody\n\n  4- Drug induced liver injury and autoimmune hepatitis\n\n  5 - cirrhosis and other causes of liver disease",{"count":566,"type":22},111,"1. Identifying the association between hyperuricemia and NAFLD can lead to early detection and prevention of liver fibrosis in adult obese patients.\n2. Understanding the relationship between hyperuricemia and NAFLD can inform targeted therapy, such as urate-lowering treatment, to potentially slow disease progression.\n\n3 - To examine the relationship between serum uric acid levels and liver fibrosis severity\\*: Assessing the correlation between serum uric acid levels and the severity of liver fibrosis in adult obese patients with NAFLD.\n\n4- To identify potential mechanisms underlying the association\\*: Exploring the potential mechanisms by which hyperuricemia may contribute to the development and progression of NAFLD and liver fibrosis in adult obese patients.",[569,570,30],"Hyperuricemia","NAFLD (Nonalcoholic Fatty Liver Disease)","2025-09-12",{"date":573,"type":35},"2025-09-15",{"date":575,"type":22},"2025-10-01",{"date":413,"type":22},{"name":318,"class":146},{"id":579,"slug":580,"hasResults":12,"nctId":581,"briefTitle":582,"officialTitle":583,"acronym":4,"eligibilityCriteria":584,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":157,"enrollmentInfo":585,"targetDuration":4,"studyType":23,"phases":587,"briefSummary":588,"conditions":589,"keywords":592,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":597,"lastUpdatePostDateStruct":598,"startDateStruct":600,"completionDateStruct":602,"leadSponsor":603,"locationsCount":605},"100476971","phase-1-single-and-multiple-dose-escalation-of-phin-214-in-child-pugh-a-and-b-liver-cirrhotics-100476971","NCT05490888","Single and Multiple Dose Escalation of PHIN-214 in Child-Pugh A and B Liver Cirrhotics","A Phase 1 Open Label Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PHIN-214 in Adults With Child Pugh A and B Cirrhosis","Key Inclusion Criteria:\n\n1. History of cirrhosis based on histology or a combination of clinical, radiological, or biochemical assessment and classified as Child-Pugh A or B\n2. Participants may be male or female aged 18 to 75 years.\n3. Body mass index (BMI) within the range 18 to 40 kg\u002Fm2 (inclusive) at screening.\n4. Female participants must be non-pregnant, non-lactating, or of non-childbearing potential or using highly efficient contraception for the full duration of the study\n\nKey Exclusion Criteria:\n\n1. Significant abnormalities in medical history or on physical examination, including: respiratory disease requiring therapy or history of respiratory failure, cardiovascular disease or hypertension, electrocardiogram abnormalities or history of significant EKG abnormalities.\n2. History of diabetes insipidus, syndrome of inappropriate antidiuretic hormone secretion, or any other disorder associated with fluid or sodium imbalance.\n3. Significant kidney disease\n4. Hepatic encephalopathy (HE) or altered mental status requiring hospitalization; variceal bleeding or upper gastrointestinal bleeding; or type 1 hepatorenal syndrome with acute kidney injury (HRS-AKI) during the previous 3 months prior to Screening.\n5. Acute-on-chronic liver failure.\n6. Recipient of a patent transjugular intrahepatic portosystemic shunt (TIPS).\n7. Known positive HIV serology confirmed by HIV viral load.\n8. Subjects with acute infections, including acute viral hepatitis (subjects with chronic hepatitis B are eligible if treatment regimen is stable ≥ 3 months prior to study inclusion).",{"count":586,"type":22},74,[478],"This 2-part study will evaluate PHIN-214 given as a single one-time dose (Part 1) and in multiple doses (given as daily doses for 28-days) (in Part 2). Specifically, this study evaluates PHIN-214, to determine the safety, tolerability, and pharmacokinetic effects of PHIN-214, and to establish the maximum tolerated dose or optimal beneficial dose in patients with Child Pugh A and B Cirrhosis.",[590,30,591],"Cirrhosis, Liver","Ascites Hepatic",[593,594,595,596],"Terlipressin","Cirrhosis","Vasoconstrictor","Refractory Ascites","2025-09-03",{"date":599,"type":35},"2025-09-05",{"date":601,"type":35},"2022-01-03",{"date":34,"type":22},{"name":604,"class":69},"PharmaIN",9,{"id":607,"slug":608,"hasResults":12,"nctId":609,"briefTitle":610,"officialTitle":611,"acronym":612,"eligibilityCriteria":613,"healthyVolunteers":247,"sex":17,"minAge":52,"maxAge":157,"enrollmentInfo":614,"targetDuration":4,"studyType":23,"phases":616,"briefSummary":618,"conditions":619,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":621,"lastUpdatePostDateStruct":622,"startDateStruct":624,"completionDateStruct":626,"leadSponsor":627,"locationsCount":629},"100544898","phase-4-fibrosis-lessens-after-metabolic-surgery-100544898","NCT06374875","Fibrosis Lessens After Metabolic Surgery","A Prospective Multicenter International Randomized Controlled Trial Comparing Surgical and Medical Therapies in the Treatment of Advanced Metabolic Dysfunction Associated Steatohepatitis","FLAMES","Inclusion Criteria\n\nEntry into the study would require that the patient:\n\n1. Is a candidate for general anesthesia\n2. Is eligible for metabolic surgery (RYGB or SG) based on the ASMBS\u002FIFSO 2022 guidelines\n3. Has insurance coverage for metabolic surgery (the requirements may vary in each country)\n4. Is ≥18 and ≤75 years old at the time of signing the informed consent\n5. Has a BMI ≥35 and ≤70 kg\u002Fm2 at the time of first study visit\n6. FIB-4 ≥ 1.3\n7. At least one of the following 5 criteria suggesting presence of advanced fibrosis:\n\n   * LSM ≥ 12 kPa by VCTE using FibroScan®\n   * LSM ≥ 12 kPa by SWE\n   * LSM ≥ 1.7 m\u002Fs by ARFI\n   * LSM ≥ 3.63 kPa MRE\n   * ELF score ≥ 9.8\n8. Patients with and without T2DM are eligible for the study. Patients with T2DM should have been on a stable dose of anti-diabetic medication (including insulin but not semaglutide or tirzepatide or liraglutide) for at least 3 months prior to entry, with glycated hemoglobin (HbA1c) ≤12%.\n9. Self-reported stable weight in 6 months before the first study visit (no weight loss \\>10% within 6 months prior to the first study visit)\n\n   a. In patients with a historical noninvasive tests or liver biopsy, weight loss of no more than 10% is allowed from 6 months prior to the historical tests until the first study visit\n10. Has the ability and willingness to participate in the study, provide informed consent, and agree to any of the arms involved in the study\n11. Can understand the options and comply with the requirements of each arm, including one liver biopsy performed during the screening period (if no adequate biopsy within 12 months before screening is available) and one liver biopsy after 2-years\n12. Has a negative urine pregnancy test at the first and at the randomization visits for women of childbearing potential.\n13. Women of childbearing age must agree to use reliable method of contraception for 2 years\n\n8.2 Exclusion Criteria\n\nPatients who meet the following criteria will be excluded from the study:\n\n1. Known history of other chronic liver diseases (drug induced, viral hepatitis, autoimmune, and genetic):\n\n   * Hepatitis B as detected by presence of hepatitis B surface antigen (HBsAg)\n   * Hepatitis C as detected by presence of hepatitis C virus (HCV) RNA (in case the screening test for hepatitis C is positive, the confirmative test is decisive)\n   * Autoimmune liver disease as diagnosed by antibodies or compatible liver histology\n   * Primary biliary cirrhosis as defined by the presence of at least 2 criteria (elevated alkaline phosphatase, presence of anti-mitochondrial antibody, and histologic evidence of nonsuppurative destructive cholangitis and destruction of interlobular bile ducts)\n   * Primary sclerosing cholangitis\n   * Wilson's disease as diagnosed by low ceruloplasmin or compatible liver histology\n   * Alpha-1-antitrypsin deficiency as diagnosed by alpha1-antitrypsin level or liver histology\n   * Hemochromatosis as diagnosed by HFE mutations (C282Y, H63D), ferritin and transferrin saturation levels, or presence of 3+ or 4+ stainable iron on liver biopsy\n   * Drug-induced liver disease diagnosed by medical history\n   * Known bile duct obstruction\n   * Suspected or proven liver cancer\n2. Weight change \\>10% within 6 months prior to the first study visit or prior to the historical liver biopsy\n3. Treatment with semaglutide, tirzepatide, or liraglutide (for obesity or for T2DM) \\\u003C90 days before the first study visit.\n\n   • However, patients are allowed to participate if they have been on a low dose (or are on older generation GLP-1 agonists) and have lost less than 10% of their body weight since starting the medication.\n4. Type 1 diabetes or autoimmune diabetes\n5. Known cases of human immunodeficiency virus infection\n6. Prior bariatric and metabolic surgery of any kind\n\n   • Reversed procedures such as gastric band or intragastric balloon that have been removed at least 3 months prior to the first study visit are allowed.\n7. Prior complex foregut surgery including any esophageal and gastric surgeries, anti-reflux procedures, biliary diversion, and complex trauma surgery\n8. Any surgery requiring general anesthesia within 1 month prior to signing the consent\n9. History of solid organ transplant\n10. Severe pulmonary disease defined as FEV1 \\\u003C 50% of predicted value\n11. Significant cardiac or atherosclerotic disease (planned to undergo cardiac, coronary, carotid, or peripheral artery revascularization procedures in the next 12 months)\n12. Severe uncompensated cardiopulmonary disease leading to American Society of Anesthesiologists Class IV or V\n13. Classified as New York Heart Association Class IV\n14. Left ventricular ejection fraction \\\u003C25% at the time of screening\n15. Myocardial infarction, unstable angina, stroke, heart surgery, coronary stent placement in the past 6 months\n16. Chronic renal insufficiency with eGFR below 30 mL\u002Fmin\u002F1.73 m2, or being on dialysis\n17. Presence of large hiatal hernia (\\>7 cm)\n18. Presence of Crohn's disease\n19. Psychiatric disorders including (but not limited to) dementia, active psychosis, severe depression requiring 3 or more medications, history of suicide attempts, active alcohol, or substance abuse within the previous 12 months that in the opinion of the investigators could disqualify the patient from metabolic surgery\n20. Pregnancy, the intention of becoming pregnant, or not using adequate contraceptive measures\n21. Breastfeeding\n22. Diagnosis of malignancy within the preceding 3 years (except squamous cell and basal cell cancer of the skin)\n23. Anemia defined as hemoglobin less than 9 g\u002FdL\n24. On therapeutic dose of anticoagulants such as warfarin or direct oral anticoagulants (DOACs)\n25. Known history of clotting disorders, including pulmonary embolus and deep vein thrombosis\n26. Clinical judgment that life expectancy is less than 3 years\n27. Use of investigational therapy within 3 months prior to signing the consent\n28. History of pancreatic carcinoma\n29. Acute pancreatitis \\\u003C 180 days before screening\n30. History or presence of chronic pancreatitis\n31. Presence of concerning thyroid nodule\n32. Uncontrolled thyroid disease: thyroid stimulating hormone (TSH) \\> 6.0 mIU\u002FL or \\\u003C 0.1 mIU\u002FL before the first study visit\n\n    * Patients receiving treatment for hypothyroidism can be included if their thyroid hormone replacement dose has been stable for at least 3 months.\n    * Patients whose TSH is outside the rang but they have normal levels of thyroid hormones can be included.\n33. A personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)\n34. Evidence or history of ascites or spontaneous bacterial peritonitis that require(d) treatment\n\n    • Trace ascites identified only by an abdominal imaging without other evidence of clinically significant portal hypertension and esophageal varices is not an exclusion criterion.\n35. Evidence or history of hepatic encephalopathy\n36. Evidence or history of variceal bleeding\n37. Evidence or history of portosplenic vein thrombosis\n38. Current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to the first study visit.\n\n    • Defined as more than 14 units\u002Fweek for females (\\>1 drink per day) and more than 21 units\u002Fweek for males (\\>2 drinks per day) on average, where one unit of alcohol is equivalent to a 12-oz beer, 4-ounce glass of wine, or 1-ounce shot of hard liquor.\n39. Treatment with medications (for more than 14 consecutive days) with known effect on liver steatosis (e.g., treatment with systemic corticosteroids \\[oral or intravenous\\], methotrexate, tamoxifen, valproic acid, amiodarone, or tetracycline) in the 3 months prior to the first study visit (or historical liver biopsy).\n40. ALT or AST or Alkaline phosphatase \\>200 U\u002FL\n41. Recurrent major hypoglycemia or hypoglycemic unawareness\n42. Inability to safely obtain a liver biopsy\n43. Any condition or major illness that, in the investigator's judgment, places the subject at undue risk by participating in the study\n44. Unable to understand the risks, benefits, and compliance requirements of study\n45. Lack capacity to give informed consent\n46. Plans to move outside the primary location of study (country) within the next 24 months\n47. Known or suspected allergy to semaglutide, tirzepatide, liraglutide, excipients, or related products\n48. Previous participation in this trial and got randomized to one of the study groups but did not proceed.\n49. Hospitalization due to COVID-19 within 2 months prior to screening.\n50. Platelet count \\\u003C80,000\n51. International Normalized Ratio (INR) \\>1.7\n52. Child-Pugh score B or C\n53. MELD score ≥15\n54. Upper endoscopy showing gastroesophageal varices\n55. Upper endoscopy showing more than mild portal hypertensive gastropathy\n56. Liver vascular ultrasound (duplex ultrasonography) showing significant portal hypertension characterized by dilated portal vein (\\>13 mm), biphasic or reverse flow in the portal vein, enlarged paraumbilical veins, splenorenal collaterals, or dilated left and short gastric veins.\n\n    Note: Negative findings on upper endoscopy and liver duplex ultrasound (done within one year of the first study visit for both tests) are necessary to establish eligibility for the FLAMES.\n    * Ruling out clinically significant portal hypertension is particularly important in patients with a liver stiffness ≥20 kPa or with a platelet count \\\u003C150,000 per μL or with a (historical) liver biopsy showing cirrhosis.\n    * A subset of patients without having upper endoscopy and liver duplex ultrasound can be eligible for enrollment if their:\n\n      * liver stiffness (by transient elastography using FibroScan®) is between 12 and 15 kPa and their platelet count is \\>150,000 per μL, or\n      * a (historical) liver biopsy showing absence of cirrhosis, or\n      * a (historical) HVPG \\\u003C 5 mmHg\n57. Cross-sectional abdominal imaging (if available historically) indicating presence of large portosystemic collaterals or ascites\n\n    • Splenomegaly alone (in the absence of other radiological and laboratory findings) is not considered to be a sign of clinically significant portal hypertension and is not an exclusion criterion.\n58. HVPG ≥ 12 mmHg (if available historically or if measured at the time of de novo liver biopsy)\n59. Liver biopsy characteristics:\n\n    * F0 in de novo biopsy; Enrollment cap of 20% for F1 in de novo biopsy.\n    * F0 and F1 in historical liver biopsy\n    * Absence of all three components of MASH (steatosis, hepatocyte ballooning, and lobular inflammation) in patients with F1, F2, and F3\n    * Absence of steatosis (\\\u003C5%) in patients with F4\n    * Diagnosis other than MASH",{"count":615,"type":22},120,[617],"PHASE4","Metabolic dysfunction-associated steatotic liver disease (MASLD), formerly known as non-alcoholic fatty liver disease (NAFLD), a major global public health concern, is commonly associated with obesity, diabetes, and dyslipidemia. MASLD is currently the most common cause of chronic liver disease affecting about 80% of people with obesity, ranging from simple fat deposits in the liver to Metabolic Dysfunction-Associated Steatohepatitis (MASH), cellular injury, advanced fibrosis, cirrhosis, or hepatocellular carcinoma. Patients with MASH are also at risk for cardiovascular disease and mortality. There is no universally approved medication for MASH. Weight loss remains the cornerstone of MASH treatment.\n\nPatients meeting the inclusion and exclusion criteria and who give informed consent will be enrolled in the trial and undergo the baseline liver biopsy (if none available). Approximately 120 patients with MASH and liver fibrosis (F1-F4 in baseline liver biopsy) will be randomized in a 1:1 ratio to metabolic surgery or medical treatment (incretin-based therapies ± other medical therapies for MASH) and followed for 2 years at which time a repeat liver biopsy will be performed for the assessment of the primary end point.",[620,122,136,30,107],"Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)","2025-08-18",{"date":623,"type":35},"2025-08-22",{"date":625,"type":35},"2024-07-11",{"date":440,"type":22},{"name":628,"class":146},"Ali Aminian",22,{"id":631,"slug":632,"hasResults":12,"nctId":633,"briefTitle":634,"officialTitle":635,"acronym":636,"eligibilityCriteria":637,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":157,"enrollmentInfo":638,"targetDuration":4,"studyType":161,"phases":4,"briefSummary":640,"conditions":641,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":646,"lastUpdatePostDateStruct":647,"startDateStruct":649,"completionDateStruct":651,"leadSponsor":653,"locationsCount":655},"100602376","evaluation-of-non-invasive-tests-for-metabolic-liver-disease-100602376","NCT07122700","Evaluation of Non-Invasive Tests for Metabolic Liver Disease","Non-Invasive Biomarkers for Metabolic Liver Disease (NIMBLE) Study 2.0 - An FNIH Biomarkers Consortium Study","NIMBLE","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Male or female, aged \\> 18 years and \\\u003C 75 years\n4. Participants must exhibit some manifestations of metabolic dysregulation. Either:\n\nA. Physician-diagnosed T2DM for at least 90 days with HbA1c \\> 6.5 and antidiabetic therapy, if any, stable for at least 90 days prior to screening or B. At least any one of the following six metabolic syndrome criteria \\[6\\]\n\n1\\. body mass index (BMI) of \\> 25 kg\u002Fm2 2. waist circumference: i. \\> 102 cm for men ii. \\> 88.9 cm for women 3. fasting triglyceride concentration \\> 150 mg\u002FdL i. or ongoing treatment with triglyceride lowering medication 4. HDL-cholesterol concentration: i. \\\u003C 40 mg\u002FdL for men ii. \\\u003C 50 mg\u002FdL for women iii. or ongoing treatment with cholesterol lowering medication. 5. fasting glucose concentration \\> 100 mg\u002FdL 6. either semi-recumbent or supine blood pressure systolic \\> 130 mmHg and\u002F or diastolic \\> 85 mmHg i. or ongoing treatment with antihypertensive medication. 5. FIB-4 \\> 1.3 (age \\\u003C 65 years) and \\> 2.0 (age \\> 65 years) 6. Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration\n\nExclusion Criteria:\n\n1. Known history or evidence of other forms of chronic liver disease other than MASLD\u002FMASH including but not limited to viral hepatitis B or C, autoimmune liver disease, primary biliary cholangitis, primary sclerosing cholangitis, Wilson disease, hemochromatosis, drug-induced liver disease, conditions involving bile duct obstructions, liver cancer, past history of HCC or HCC treatment, listed for or history of liver transplantation, prior resection of liver, etc.\n2. Current or past evidence of decompensated liver disease defined by overt ascites that is clinically obvious and requires diuretic therapy, overt encephalopathy requiring therapy or history of variceal hemorrhage\n3. Circulating Alanine aminotransferase (ALT)\\> 5xULN\n4. Ongoing or recent (within the last two years prior to screening) consumption of significantly greater than moderate amounts of alcohol.\n\n   * A standard alcoholic drink is any drink that contains about 14 g of pure alcohol, such as 12 fluid ounces of regular beer 8-10 fluid ounces of malt liquor or flavored malt beverages such as hard seltzer 5 fluid ounces of table wine 3-4 fluid ounces of fortified wine such as sherry or port 2-3 fluid ounces of cordial liqueur or aperitif 1.5 fluid ounces (a single jigger or shot) of brandy, cognac, or distilled spirits such as gin, rum, tequila, vodka, whiskey, etc.\n   * Significantly greater than moderate alcohol consumption is defined as on average over a 2-year period prior to screening:\n\n   Women\n   * \\>1 standard drink per day and\u002For\n   * \\>14 standard drinks per week Men\n   * \\>2 standard drinks per day and\u002For\n   * \\>21 standard drinks per week in men\n\n     * An Alcohol Use Disorders Identification Test (AUDIT) score of 7 or higher\n     * A PEth test score of ≥ 20ng\u002Fml.\n5. In the opinion of the investigator, any contraindications to liver biopsy including but not limited to having significant uncorrected coagulopathy or thrombocytopenia, on chronic anticoagulation with Direct Oral Anticoagulants (DOACs), or on low dose heparin or Warfarin.\n6. Uncontrolled systolic blood pressure \\> 180 mmHg and diastolic blood pressure \\> 120 mmHg at screening. Blood pressure will be obtained after at least 10 minutes of resting in a semi-recumbent or supine position.\n7. Any systemic disease that in the opinion of the investigator precludes inclusion of the patient in the trial\n8. Unable or unwilling to provide informed consent\n9. Unwilling to undergo liver biopsy procedure\n10. Unable or unwilling to comply with requirements for study procedures (such as fasting)\n11. Unable to perform study procedures in the opinion of the investigator\n12. Participants who are unwilling or unable (e.g. due active implants such as pacemaker or having a waist diameter (calculated as: diameter = circumference \u002F π) 70cm, unless a wide-bore MRI machine is available) to undergo MRI procedures.\n13. Pregnancy or planned pregnancy within 4 months of screening.\n14. Participation in another clinical trial within 30 days, or dosing with an investigational agent within 90 days prior to signing the ICF for this study.",{"count":639,"type":22},400,"The Non-Invasive Biomarkers for Metabolic Liver Disease (NIMBLE) study is a comprehensive, multi-year collaborative effort to standardize, validate and advance the regulatory qualification of blood- and imaging-based biomarkers to diagnose and stage Metabolic dysfunction-associated steatohepatitis (MASH), previously known as nonalcoholic steatohepatitis (NASH). MASH is characterized by liver inflammation accompanied by simultaneous fat accumulation in the liver.",[642,643,590,644,30,109,332,645],"Metabolic Associated Fatty Liver Disease","Metabolic Associated Steatotic Liver Disease","NASH","Liver Inflammation","2025-08-07",{"date":648,"type":35},"2025-08-14",{"date":650,"type":35},"2025-05-13",{"date":652,"type":22},"2026-07-31",{"name":654,"class":146},"Foundation for the National Institutes of Health",4,{"id":657,"slug":658,"hasResults":12,"nctId":659,"briefTitle":660,"officialTitle":661,"acronym":662,"eligibilityCriteria":663,"healthyVolunteers":12,"sex":17,"minAge":664,"maxAge":4,"enrollmentInfo":665,"targetDuration":4,"studyType":23,"phases":667,"briefSummary":668,"conditions":669,"keywords":674,"overallStatus":232,"whyStopped":4,"lastUpdateSubmitDate":679,"lastUpdatePostDateStruct":680,"startDateStruct":682,"completionDateStruct":684,"leadSponsor":686,"locationsCount":688},"100595931","community-screening-and-management-of-hepatitis-b-c-and-delta-in-the-mongolian-population-living-in-france-100595931","NCT07038863","Community Screening and Management of Hepatitis B, C and Delta in the Mongolian Population Living in France","Community Screening for Hepatitis B, C and Delta in the Mongolian Population Living in France","Mondelta","Inclusion Criteria:\n\n* Mongolian people\n* Over 15 years of age\n* Living in France\n* Majors agree to participate or minors whose parental guardians agree to their child's participation in the study\n\nExclusion Criteria:\n\n* People already followed for viral hepatitis, treated or not treated\n* Persons deprived of their liberty by a judicial or administrative decision\n* Adults subject to a legal protection measure (guardianship, curators)\n* People participate in any interventional research except routine care research (old regulation) and category 2 research that does not interfere with the primary endpoint analysis","15 Years",{"count":666,"type":22},2000,[25],"In Mongolia, mortality from hepatocellular carcinoma (HCC) is one of the highest in the world. Viral hepatitis is the main cause of HCC: the prevalence of hepatitis B (HBV) estimated at 11% In Mongolia, hepatitis C (HCV) at 8.5%, and hepatitis Delta (HDV) at 40-60% in HBV-infected patients. Viral hepatitis are essentially asymptomatic and therefore require systematic screening for diagnosis. Once a diagnosis of chronic viral infection has been established, specific therapies are available to reduce the morbidity and mortality of these patients. A study carried out in California in the Mongolian community found an HBV prevalence of 9.7% and positive HDV serology in 41% of these patients.\n\nThere is a large Mongolian community in France, estimated at between 5,000 and 6,000 patients. Although the majority of these patients are covered by French social security; however, access to care and screening for viral hepatitis often remain difficult and insufficient for migrant or vulnerable populations in France The aim of this study is to screen the Mongolian community in France for viral hepatitis, and then initiate a program of care and treatment.",[670,671,672,673,30],"HEPATITIS C (HCV)","Hepatitis B Virus (HBV)","Hepatitis D","Hepatocellular Carcinoma (HCC)",[675,676,677,678],"HBV","HCV","HDV","HCC","2025-06-18",{"date":681,"type":35},"2025-06-26",{"date":683,"type":22},"2025-09-01",{"date":685,"type":22},"2028-05-01",{"name":687,"class":146},"Hospices Civils de Lyon",11]