[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"non-alcoholic-steatohepatitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:non-alcoholic-steatohepatitis":266},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,17,0,[8,47,102,126,151,172,202,224,242,298,320,343,368,393,421,442,464],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100353606","phase-2-non-alcoholic-fatty-liver-disease-the-hepatic-response-to-oral-glucose-and-the-effect-of-semaglutide-nafld-heroes-100353606",false,"NCT03884075","Non-Alcoholic Fatty Liver Disease, the HEpatic Response to Oral Glucose, and the Effect of Semaglutide (NAFLD HEROES)","Non-Alcoholic Fatty Liver Disease, the Hepatic Response to Oral Glucose, and the Effect of Semaglutide (NAFLD HEROES)","* INCLUSION CRITERIA:\n\n  1. Male or female Aged \\>= 18 years of age.\n  2. Histological evidence of hepatic steatosis on a liver biopsy within 12 months OR evidence of fatty liver disease, as documented by imaging (ultrasound, CT, MRI, MRI-PDFF, MR spectroscopy, or Fibroscan CAP \\>= 285 db\u002FM25) within 12 months.\n  3. Estimated average alcohol consumption \\\u003C 30 g\u002Fd for men or \\\u003C 20 g\u002Fd for women in the 6 months prior to enrollment and no binge-drinking behavior.\n  4. Ability of subject to understand and the willingness to sign a written informed consent document.\n\nAdditional Inclusion Criteria for Treatment Phase\n\n1. Presence of NAFLD (steatosis grade greater than or equal to 1 on NASH-CRN scoring scale) on baseline admission liver biopsy.\n2. Liver fat content greater than or equal to 10% by 1H-MRS on initial admission.\n\nEXCLUSION CRITERIA:\n\n1. Pregnant or breast-feeding\n2. Chronic infection with hepatitis C virus (HCV) or hepatitis B virus (HBV). Patients who were treated successfully for HCV and achieved sustained virological response can be eligible for enrollment \\> 18 months after treatment cessation. Patients receiving antiviral therapy are ineligible.\n3. HIV infection.\n4. Concomitant liver disease such as autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, Wilson s disease, alpha-1 antitrypsin deficiency, hereditary hemochromatosis.\n5. Presence of definite or probable drug-induced liver injury. In the case of lipid-lowering, anti-hypertensive or anti-diabetic medications that are suspected to cause aminotransferase elevation, patients will be eligible if treatment is associated with stable enzyme levels for at least 6 months.\n6. Decompensated advanced liver disease, defined as direct bilirubin \\> 0.5 g\u002FdL, PT \\> 18 , albumin \\\u003C 3 g\u002FdL, MELD score \\> 12 (applicable only in patients without Gilbert s syndrome), or history of ascites, encephalopathy, variceal bleeding, spontaneous bacterial peritonitis or liver transplant\n7. Treatment with medications known to cause fatty liver disease such as atypical neuroleptics, tetracycline, methotrexate or tamoxifen\n8. Uncontrolled hypo- or hyperthyroidism.\n9. Thyroid nodules with ultrasonographic features suggestive of an increased risk of thyroid cancer per radiologist reporting (hypoechoic, microcalcifications, twinkling on B flow imaging, central vascularity, irregular margins, incomplete halo, nodule taller than wide and documented enlargement of a nodule), or nodules associated with an abnormal TSH (0.4 to 5 mU\u002FL).\n10. Active coronary artery disease, defined as persistent angina pectoris, reversible ischemia on cardiac stress test or imaging, or the presence of significant coronary artery disease on imaging or catheterization. Patients with coronary artery disease that was treated by angioplasty or bypass surgery may be eligible if they have no evidence of active disease \\>= 1 year after intervention, can safely stop antiplatelet and anticoagulant medications before the performance of invasive procedures, and have adequate ventricular function as assessed by echocardiography or cardiology consultation. These patients will require cardiology consultation and clearance prior to enrollment.\n11. Congestive heart failure.\n12. Chronic kidney disease, with creatinine clearance \\\u003C 60 ml\u002Fmin or eGFR \\\u003C 60\u002Fml\u002Fmin\u002Fm(2).\n13. Uncontrolled diabetes mellitus with HbA1c \\> 9% will exclude subjects. Patients with diabetes may be enrolled only if they have HbA1c \\\u003C=9%, have been on stable therapy with lifestyle and\u002For metformin for at least 3 months prior to enrollment, and are not foreseen to require change of antidiabetic medication or dose during the trial.\n14. Use of insulin, sulfonylurea agents, thiazolidinediones, SGLT2 inhibitors, GLP-1 receptor agonists or DPP-4 inhibitors unless discontinued greater than or equal to 3 months before enrollment.\n15. Contraindication or inability to perform a liver biopsy.\n\n    1. Patients with coagulopathy (PT\u002FPTT values that are prolonged greater than or equal to 3 seconds from the upper limit of the normal, including treatment with oral and parenteral anticoagulants), thrombocytopenia (\\\u003C 70,000), abnormal bleeding time or platelet dysfunction. Antiplatelet agents taken for cardiovascular prevention will not exclude patients, unless they cannot be stopped safely for the performance of a liver biopsy.\n    2. Hemoglobin level \\\u003C 11 g\u002FdL\n16. Contraindications to MRI (heart pacemakers, unless MRI safe, insulin pumps, implanted hearing aids, neurostimulators, intracranial metal clips, metallic bodies in the eye, metal hip replacements, sutures, extreme anxiety or fear of small spaces.)\n17. History of gastric bypass or other bariatric surgery, partial or complete gastrectomy and known maldigestion or malabsorption.\n18. Treatment with orlistat.\n19. Patients with uncontrolled eating disorders including anorexia and bulimia nervosa.\n20. Patients with proliferative diabetic retinopathy.\n21. Use of medications or supplements to treat NAFLD (approved or unapproved) unless withdrawn greater than or equal to 3 months prior to enrollment or taken at a stable dose for greater than or equal to 6 months.\n22. Patients who had a liver biopsy performed less than or equal to 2 years before enrollment, unless they are willing to undergo all of the trial biopsies, knowing that these biopsies are purely for research and are not clinically indicated. This will be clearly documented in the patients charts prior to enrollment.\n23. Inability or unwillingness to receive subcutaneous injections.\n24. Known or suspected allergy to trial medication(s), excipients, or related products.\n25. Alcohol or substance abuse within the past 12 months.\n26. For women of childbearing potential, breast-feeding, pregnancy or inability or unwillingness to practice contraception for the duration of the study.\n27. Personal or first-degree family member with history of medullary thyroid carcinoma or subjects with known multiple endocrine neoplasia syndrome type 2 (MEN-2).\n28. Actively pursuing an intensive weight loss regiment, aimed at losing \\> 10% of current body weight, by following a different diet or exercise regimen over the study time period or recent (\\\u003C3 months) significant weight loss (\\>10%).\n29. The receipt of any investigational drug within 3 months prior to enrollment in this trial.\n30. Assessment by the principal investigator that the subject will be unlikely to complete the study procedures, or that enrollment puts the subject at a significant risk unspecified by the criteria above.\n\nINCLUSION CRITERIA for Healthy Volunteers (arm C)\n\n1. Male or female Aged greater than or equal to 18 years of age.\n2. No evidence of hepatic steatosis by imaging or histology.\n3. No history of known liver disease.\n4. Individuals on regular systemic medications may be considered eligible, and their eligibility will be determined by the principal investigator.\n5. BMI less than or equal to 25 kg\u002Fm2\n6. Non-diabetic.\n7. Normal transaminases (ALT less than or equal to 31 U\u002FL for men or less than or equal to 19 U\u002FL for women, and AST less than or equal to 30 U\u002FL).\n8. Fasting glucose less than or equal to 95 mg\u002FdL.\n9. Ability of subject to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA for Healthy Volunteers (arm C)\n\n1. Pregnant or breastfeeding\n2. Excessive alcohol consumption, defined as an average alcohol consumption over \\> 1 drink per day over the past month\n3. Assessment by the principal investigator that the subject is unsuitable for participation in the study or that enrollment puts the subject at significant risk.",true,"ALL","18 Years","100 Years",{"count":21,"type":22},104,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","Background:\n\nIn non-alcoholic fatty liver disease (NAFLD), fat accumulates in the liver and can cause damage. Researchers want to learn what causes the damage NAFLD, and to see if a medication can help.\n\nObjective:\n\nTo find out how the liver in people with NAFLD responds to feeding, and how this relates to their response to the drug semaglutide.\n\nEligibility:\n\nPeople with NAFLD and healthy volunteers ages 18 and older\n\nDesign:\n\nParticipants will be screened with:\n\nMedical history\n\nPhysical exam\n\nBlood tests\n\nImaging: A machine will take pictures of the participant s body.\n\nWithin 2-8 weeks of enrollment, participants will stay in the clinic for several days. This includes:\n\nBlood, urine, heart, and imaging tests\n\nFor NAFLD participants only: A needle-like device will remove a small biopsy of the liver and fatty tissue.\n\nParticipants will be alone in a special room for 5 hours. They will breathe through a tube under the nostrils. They will have blood drawn several times.\n\nThe baseline visit concludes participation for healthy volunteers but NAFLD participants will contine.\n\nAbout 6 weeks after discharge, participants will stay in the clinic again and repeat the tests. They will get their first semaglutide dose by injection.\n\nParticipants will have visits weeks 1, 2, 4, 8, 12, 16, 20, and 24 of treatment. Visits include blood tests.\n\nParticipants will inject semaglutide once a week at home.\n\nAt week 30, participants will stay in the clinic again and repeat the tests.\n\nParticipants will have a final visit 12 weeks after stopping treatment. This includes blood and urine tests.\n\n...",[28,29],"Non-Alcoholic Steatohepatitis","Non-Alcoholic Fatty Liver Disease",[31,32,33],"Non-Alcoholic Steatohepatitis (NASH)","Steatosis","Caloric Load","RECRUITING","2026-06-30",{"date":37,"type":38},"2026-07-01","ACTUAL",{"date":40,"type":38},"2019-07-24",{"date":42,"type":22},"2026-10-02",{"name":44,"class":45},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":58,"conditions":59,"keywords":78,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":101},"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":55,"type":22},132,[57],"NA","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.",[60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,29,76,77],"Obesity","Liver Diseases","Liver Fibrosis","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","Non-alcoholic Steatohepatitis",[79,80,81,82,83,84,85,86,87,88,89,90,31],"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)","2026-06-23",{"date":93,"type":38},"2026-06-25",{"date":95,"type":38},"2025-06-24",{"date":97,"type":22},"2028-06",{"name":99,"class":100},"Pichamol Jirapinyo, MD, MPH","OTHER",2,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":112,"phases":4,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":101},"100579101","identification-of-liver-fibrosis-biomarkers-100579101","NCT06819917","Identification of Liver Fibrosis Biomarkers","Prospective Sample Collection Study for Discovery and Evaluation of Novel Blood Based Biomarkers for Assessment of Hepatic Fibrosis","Inclusion Criteria:\n\n* Patients scheduled for biopsy (or F0-F2 patients that underwent biopsy within the last 6 months but at least 1 month ago) suspected of having hepatic fibrosis due to NAFLD (NAFL\u002FNASH) or patients with MASLD or MASH\n* Any FIB-4 value available\n* Any Fibroscan value available\n* Written and signed informed consent present\n* Patients aged ≥ 18 years to ≤ 75 years at the time of the blood draw\n* Body Mass Index (BMI) ≤ 45 kg\u002Fm²\n\nExclusion Criteria:\n\n* Vulnerable person: person deprived of liberty by a judicial or administrative decision and\u002For person under psychiatric care\n* Self-reported pregnancy or lactating females\n* Disease related to other etiologies, including alcoholic liver disease (alcoholic steatohepatitis), MetALD, specific etiology SLD (e.g. DILI or monogenic disease), cryptogenic SLD, viral hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, autoimmune hepatitis, human immunodeficiency virus, Wilson's disease, Hemochromatosis, alpha-1 antitrypsin deficiency\n* Any type of carcinoma, unless it is at least 5 years in remission\n* Prior liver transplant\n* Evidence of any other unstable or, untreated clinically significant immunological, neoplastic, endocrine, haematological, gastrointestinal, neurological or psychiatric disorder. Medically controlled comorbidities can be allowed\n* Self-reported alcohol consumption greater 30 g\u002Fday (males) 20 g\u002Fday (females)\n* Recent myocardial infarction (within last 6 months)\n* Inability to have a liver biopsy, or provide blood sample in a fasted status\n* F0-F2 recalled patients with +\u002F- 5% change in weight between the biopsy and study inclusion","75 Years",{"count":111,"type":22},575,"OBSERVATIONAL","Chronic liver disease (CLD) is a major cause of global mortality and morbidity . CLD patients are at an increased risk of developing liver fibrosis (formation of scar tissue), cirrhosis and liver failure and are at significant risk to develop primary liver cancer. Non-alcoholic fatty liver disease (NAFLD) represents a major risk for CLD and it is becoming the most common chronic liver condition with an estimated 25% global prevalence. Progression to non-alcoholic steatohepatitis (NASH) occurs in approx. 1 of 5 NAFLD patients and due to the rapidly rising etiology of end-stage liver disease, is currently the second most common etiology of hepatocellular carcinoma (HCC) requiring liver transplantation. Liver biopsy, currently the gold-standard for grading disease activity and staging fibrosis, is invasive, costly and at risk for sampling error. Due to the number of patients diagnosed with fibrosis and since fibrosis stage is prognostic of mortality and drives patient management, it is important to develop noninvasive yet accurate diagnostic tools that can identify fibrosis stage. The purpose of this study is to obtain a panel of clinically well characterized blood specimens to identify novel biomarkers to be used as an aid in diagnosis to assess the stage of clinically significant hepatic fibrosis in patients with signs or symptoms of NAFLD (NAFL\u002FNASH). In addition, quantitative ultrasound (QUS) based approaches combined with artificial intelligence (AI) algorithms will be explored for assessing the stage of fibrosis.",[115,29,77],"Non-alcoholic Fatty Liver","2026-05-22",{"date":118,"type":38},"2026-05-27",{"date":120,"type":38},"2025-02-01",{"date":122,"type":22},"2026-12",{"name":124,"class":125},"Roche Diagnostics GmbH","INDUSTRY",{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":112,"phases":4,"briefSummary":135,"conditions":136,"keywords":140,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":46},"100487136","chronic-hepatopathies-associated-with-alcohol-consumption-and-metabolic-syndrome-100487136","NCT05623150","CHronic Hepatopathies Associated With ALcohol Consumption aNd metAbolic Syndrome","CHALNA2","Inclusion Criteria:\n\n* Criteria common to all patients:\n\n  1. Affiliation to French social security.\n  2. Male or female ≥ 18 years of age\n  3. Patients able to receive and understand information about the research and to give written informed consent duly signed by the patient and the investigator (at the latest on the day of inclusion and before any examination necessary for the research).\n* Patients in the NAFLD group with HCC:\n\n  1. Alcohol consumption ≤ 30 g pure alcohol\u002Fd (or 210 g pure alcohol\u002Fweek) for men and ≤ 20 g pure alcohol\u002Fd (140 g pure alcohol\u002Fweek) for women.\n  2. Decision, less than 3 months old, of liver biopsy of the suspected HCC nodule and non-tumour liver tissue performed as a clinical routine.\n  3. No systemic treatment for HCC within 6 months prior to inclusion.\n* Patients in the NAFLD group without HCC:\n\n  1. Alcohol consumption ≤ 30 g pure alcohol\u002Fd (or 210 g pure alcohol\u002Fweek) for men and ≤ 20 g pure alcohol\u002Fd (140 g pure alcohol\u002Fweek) for women.\n  2. Decision of less than 3 months of a liver biopsy performed as a clinical routine. Biopsy will be motivated by liver function disturbance(s) and\u002For ultrasound steatosis given the lack of validated non-invasive tests or the lack of accuracy (grey areas) of available non-invasive tests for the diagnosis of necro-inflammation and\u002For fibrosis in some of these patients.\n* Patients in the alcohol-related liver disease group with HCC:\n\n  1. Alcohol consumption \\> 30 g pure alcohol\u002Fd (or 210 g pure alcohol\u002Fweek) for men and \\> 20 g pure alcohol\u002Fd (140 g pure alcohol\u002Fweek) or binge drinking\n  2. Decision within 3 months of liver biopsy of suspected HCC nodule and non-tumour liver tissue performed as part of clinical routine\n  3. No systemic treatment for HCC within 6 months prior to inclusion.\n* Patients in the alcohol-related liver disease group without HCC:\n\n  1. Alcohol consumption \\> 30 g pure alcohol\u002Fd (or 210 g pure alcohol\u002Fweek) for men and \\> 20 g pure alcohol\u002Fd (140 g pure alcohol\u002Fweek) or binge drinking\n  2. Decision of less than 3 months for a liver biopsy to be performed as a clinical routine. Biopsy will be motivated by liver balance disturbance(s) and\u002For ultrasound steatosis given the lack of validated non-invasive tests or the lack of accuracy (grey areas) of available non-invasive tests for the diagnosis of necro-inflammation and\u002For fibrosis in some of these patients.\n\nExclusion Criteria:\n\n1. Positive HIV serology\n2. Patients with detectable hepatitis C viral load\n3. Presence of Hbs antigen\n4. History of autoimmune hepatitis type 1 or 2, primary biliary cholangitis, primary sclerosing cholangitis, Wilson's disease, genetic haemochromatosis homozygous, alpha1 anti-trypsin deficiency\n5. Long-term use of methotrexate, corticosteroids, anti-Tumor Necrosis Factor cyclosporine, tacrolimus\n6. History of solid organ transplantation or bone marrow transplantation\n7. Cancerous disease in the process of being treated, except for skin cancer (excluding melanoma)\n8. Patients under legal protection or unable to express their consent,\n9. Pregnant or breastfeeding women",{"count":134,"type":22},710,"The aim is to determine the metabolic factors, host immune factors, and medical imaging data associated with the development of HepatoCellular Carcinoma (HCC) in patients with alcohol-related liver disease or dysmetabolic steatosis\u002FNon-Alcoholic SteatoHepatitis.\n\nThe investigators will include patients with and without cirrhosis in order to identify early molecular mechanisms involved in the development of HCC especially in non-cirrhotic patients.",[29,28,137,138,139],"Alcohol-related Liver Disease","Cirrhosis, Liver","Hepatocellular Carcinoma",[29,28,137,138,139],"2026-04-13",{"date":143,"type":38},"2026-04-16",{"date":145,"type":38},"2022-12-06",{"date":147,"type":22},"2032-03",{"name":149,"class":150},"Institut National de la Santé Et de la Recherche Médicale, France","OTHER_GOV",{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":158,"targetDuration":160,"studyType":112,"phases":4,"briefSummary":161,"conditions":162,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":101},"100495247","endoscopic-ultrasound-shear-wave-elastography-in-patients-with-non-alcoholic-fatty-liver-disease-100495247","NCT05728697","Endoscopic Ultrasound Shear Wave Elastography in Patients With Non-alcoholic Fatty Liver Disease","Endoscopic Ultrasound Shear Wave Elastography: A Novel Tool for Fibrosis Screening in Patient With Elevated Body Mass Index and Suspected Non-Alcoholic Fatty Liver Disease or Steatohepatitis","Inclusion Criteria:\n\n* Adults 18 years or older\n* Planned for clinically indicated endoscopic ultrasound with plan for follow up liver biopsy\n* Suspected or confirmed non alcoholic fatty liver disease prior to procedure\n* Body mass index \\>=25\n\nExclusion Criteria:\n\n* Inadequate liver biopsy sample",{"count":159,"type":22},150,"1 Week","The goal of this observation study is to assess whether endoscopic ultrasound shear wave elastography (EUS-SWE) may be a useful tool for liver fibrosis screening in patients with elevated body mass index and non alcoholic fatty liver disease as compared to other non-invasive screening modalities, which have traditionally had less accurate results in this population.\n\nThe main questions it aims to answer are:\n\n* Determine accuracy of EUS-SWE for liver fibrosis screening compared to other non-invasive scoring systems, such as the FIB-4 score and Fibroscan in patients with elevated body mass index\n* Establish optimal stiffness (kPa) cutoffs for liver fibrosis grading for EUS-SWE for this patient population in reference to the gold standard liver biopsy, as no standard cutoffs currently exist.\n\nParticipants will undergo routine endoscopic ultrasound as part of their standard clinical care and indication. Participants are consented for the procedure and undergoing the shear wave elastography. In addition to their standard ultrasound test, it takes on average an extra 2-3 minutes to perform the shear wave elastography. The procedure itself adds no additional risk to the patient and does not expose them to radiation.",[29,77,60],"2026-02-26",{"date":165,"type":38},"2026-03-02",{"date":167,"type":38},"2021-06-01",{"date":169,"type":22},"2027-01",{"name":171,"class":100},"Brigham and Women's Hospital",{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":176,"acronym":177,"eligibilityCriteria":178,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":112,"phases":4,"briefSummary":181,"conditions":182,"keywords":188,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":46},"100415541","constitution-of-a-biological-collection-to-establish-preclinical-translational-models-for-the-study-of-tumors-and-chronic-liver-diseases-100415541","NCT04690972","\"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases\".","LivMOD","Inclusion Criteria:\n\n1. Patients\n\n   * diagnosed with chronic liver disease (viral or not)\n   * diagnosed with at least one liver nodule for which a biopsy is planned as part of the care\n   * for hepatobiliary surgery planned as part of care\n   * for locoregional treatment for HCC is indicated\n2. Patients able to receive and understand information relating to the study and give their written informed consent\n3. Patients affiliated to the French social security system\n\nExclusion Criteria:\n\n1. Minor patients\n2. Patients under legal protection,\n3. Patients subject to legal protection or unable to express their consent,\n4. Patients in a situation of social fragility,\n5. Pregnant or breastfeeding woman,\n6. No signing of informed consent.",{"count":180,"type":22},800,"Development of preclinical translational models for chronic liver tumors and diseases study, such as spheroids cultured in autologous medium and murine xenograft models to test the efficacy of new therapeutic strategies.",[183,184,29,28,185,186,187],"Chronic Liver Disease and Cirrhosis","Liver Cancer","Viral Hepatitis B","Viral Hepatitis C","Viral Hepatitis D",[189,190,191,192,193],"Liver disease","Ex vivo models","Single cell","Biomarkers","Spheroïds","2026-02-10",{"date":196,"type":38},"2026-02-12",{"date":198,"type":38},"2021-01-14",{"date":200,"type":22},"2029-09-02",{"name":149,"class":150},{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":206,"acronym":207,"eligibilityCriteria":208,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":209,"targetDuration":4,"studyType":112,"phases":4,"briefSummary":211,"conditions":212,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":46},"100413654","integrated-diagnostics-for-early-diagnosis-of-liver-disease-100413654","NCT04666402","Integrated Diagnostics for Early Diagnosis of Liver Disease","ID LIVER","Inclusion Criteria:\n\n* All patients referred to Community Liver Assessment Clinic.\n* Male or female \\> 18 years of age.\n* Females will be non-pregnant and non-lactating.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years.\n* Pregnancy\u002Fbreast-feeding. Women of childbearing potential (not \\>2 years post- menopausal and\u002For not surgically sterilised) must have a negative blood serum pregnancy test.\n* Isolated bilirubinaemia.\n* Known pre-existing liver disease.\n* Acutely unwell.\n* Suspected malignancy.",{"count":210,"type":22},1200,"This is an observational study that will explore the hypothesis that by combining data from patients with liver disease with novel blood biomarkers, single nucleotide polymorphism (SNP) analysis and faecal microbiome analysis. The Investigators will improve diagnosis of liver fibrosis compared to the current available diagnostic tools.",[29,77,213,214],"Alcoholic Liver Disease","Liver Fibroses","2026-02-05",{"date":217,"type":38},"2026-02-09",{"date":219,"type":38},"2020-10-21",{"date":221,"type":22},"2027-03-31",{"name":223,"class":150},"Manchester University NHS Foundation Trust",{"id":225,"slug":226,"hasResults":11,"nctId":227,"briefTitle":228,"officialTitle":228,"acronym":4,"eligibilityCriteria":229,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":230,"targetDuration":4,"studyType":23,"phases":231,"briefSummary":232,"conditions":233,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":240,"locationsCount":46},"100390586","the-olmsted-nafld-epidemiology-study-tones-100390586","NCT04365855","The Olmsted NAFLD Epidemiology Study (TONES)","Inclusion Criteria:\n\n* Olmsted County residents at the time of search\n* Age 18 or older\n* No personal history of NAFLD diagnosis (administrative codes)\n\nExclusion Criteria:\n\n* Alcohol in excess (more than 20 gm per week in women and 30 gm per week in men)\n* Currently pregnant\n* Have contraindications to MRI (MRI incompatible implanted devices, severe claustrophobia)",{"count":180,"type":22},[57],"Researchers are assessing the prevalence of Non-alcoholic Fatty Liver Disease (NAFLD) and Nonalcoholic Steatohepatitis (NASH) in the population and assembling a well-characterized cohort of adults with NAFLD and NASH to validate models of NAFLD diagnosis and determine long-term outcomes.",[29,28],"2026-01-14",{"date":236,"type":38},"2026-01-16",{"date":238,"type":38},"2020-10-10",{"date":97,"type":22},{"name":241,"class":100},"Mayo Clinic",{"id":243,"slug":244,"hasResults":11,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":4,"eligibilityCriteria":248,"healthyVolunteers":16,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":249,"targetDuration":251,"studyType":112,"phases":4,"briefSummary":252,"conditions":253,"keywords":284,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":46},"100474891","inadvance-surveillance-prevention-and-interception-in-a-population-at-risk-for-cancer-100474891","NCT05463796","InAdvance: Surveillance, Prevention, and Interception in a Population at Risk for Cancer","InAdvance: Surveillance, Prevention, and Interception in a Population at Risk For Cancer","Inclusion Criteria:\n\n* Participants to be included in this study include the following (note that this list is not comprehensive but gives examples of precursor conditions for each organ type):\n\n  1-Hereditary risk for cancer including\n  * Carriers of known or previously unrecognized pathogenic germline variants of cancer predisposing genes\n  * Individuals with personal or family history suggestive of elevated cancer risk (this may include individuals who have negative genetic testing results or have not elected to undergo testing)\n  * Individuals with a clinically based diagnosis of a Cancer Predisposition Syndrome (examples, neurofibromatosis, Fanconi Anemia, Ataxia-Telangiectasia)\n  * Hereditary Cancer Prediction Model-based elevated cancer risk\n  * Others at risk for specific cancers by virtue of exposure, obesity, gender, race and ethnicity, HPV exposure (for H\\&N cancer for example), etc.\n* Exposed High Risk including\n\n  * Childhood cancer survivors with treatment exposures associated with increased risk of cancer\n  * Adult cancer survivors with treatment exposures associated with increased risk of cancer\n  * Documented high level exposure to group 1 IARC carcinogens\n  * Thoracic: individuals at risk for lung cancer including but not exclusive of the following criteria: Age \\>50, Smoking history of \\>15 pack years, First-degree relative history of lung cancer or COPD\n  * alcoholic liver disease (NAFL), non-alcoholic steatohepatitis (NASH), cirrhosis\n* Precursor Lesions including\n\n  * Breast: ductal\u002Flobular carcinoma in situ (CIS) and atypical hyperplasia\n  * GI: Barrett's esophagus, Pancreatic precursor lesions, colonic dysplasia\u002Fadenomata, nonalcoholic fatty liver (NAFL), nonalcoholic steatohepatitis (NASH), cirrhosis\n  * GU: High grade prostatic epithelial neoplasia, and high-grade bladder urothelial dysplasia\u002Fcarcinoma in situ,\n  * Lung: Adenomatous hyperplasia\n  * H\\&N: high-risk oral precancerous diseases\n  * Skin: Class II melanocytic lesions. Squamous dysplasia\n  * Heme malignancies: CHIP, CCUS, ICUS, MGUS, SMM, SWM, MBL (spell these out), Low grade lymphomas\n  * Thoracic: Lung nodules detected on screening CT that prompt further follow-up\n  * GYN: STIC lesion (serous tubal intraepithelial carcinoma), Endometrial intraepithelial neoplasia, Cervical and endocervical carcinoma in situ, vulvar intraepithelial neoplasia\n  * Pediatric histologic diagnoses sometimes associated with development of malignancy: Nephrogenic rests, benign bone lesions with risk of malignant degeneration (Giant cell tumor, osteochondroma), Spitz nevus, and others.\n* FAMILY MEMBERS or healthy individuals\n\nExclusion Criteria:\n\nThere are no exclusion criteria for the study.\n\nNote: Patients with prior cancer history are allowed to participate. Patients with prior history of cancer or non-metastatic localized cancers (such as skin cancer or localized prostate cancer) are allowed to be enrolled. Patients enrolled in clinical trials or receiving therapy for precursor diseases are NOT excluded from this study.",{"count":250,"type":22},5000,"20 Years","This research study is creating a way to collect and store specimens and information from participants who may be at an increased risk of developing cancer, or has been diagnosed with an early phase of a cancer or a family member who has a family member with a precursor condition for cancer.\n\n* The objective of this study is to identify exposures as well as clinical, molecular, and pathological changes that can be used to predict early development of cancer, malignant transformation, and risks of progression to symptomatic cancer that can ultimately be fatal.\n* The ultimate goal is to identify novel markers of early detection and risk stratification to drive potential therapeutic approaches to intercept progression to cancer.",[254,255,256,257,258,259,260,261,262,263,264,265,29,266,267,268,269,270,271,272,273,274,275,276,277,278,279,280,281,282,283],"Cancer Risk","Cancer Predisposition Syndrome","Hereditary Cancer Prediction","Childhood Cancer Survivors","Adult Cancer Survivors","IARC Carcinogens","Smoking History","Lung Cancer","Ductal\u002FLobular Carcinoma","Barrett Esophagus","Pancreatic Precursor Lesions","Colonic Dysplasia\u002FAdenomata","Non Alcoholic Steatohepatitis","Cirrhosis","High Grade Prostatic Epithelial Neoplasia","High-grade Bladder Urothelial Dysplasia\u002FCarcinoma in Situ","Adenomatous Hyperplasia","High-risk Oral Precancerous Diseases","Melanocytic Lesion, Adult","Hematologic Malignancy","Lung; Node","Serous Tubal Intraepithelial Carcinoma","Endometrial Intraepithelial Neoplasia","Cervical and Endocervical Carcinoma in Situ","Vulvar Intraepithelial Neoplasia","Nephrogenic Rests","Benign Bone Lesions With Risk of Malignant Degeneration","Giant Cell Tumor","Osteochondroma","Spitz Nevus",[285,286,287,288],"Hereditary Risk for Cancer","Childhood cancer survivors","Adult cancer survivors","Precursor Lesions","2025-08-04",{"date":291,"type":38},"2025-08-07",{"date":293,"type":38},"2023-04-25",{"date":295,"type":22},"2032-03-25",{"name":297,"class":100},"Dana-Farber Cancer Institute",{"id":299,"slug":300,"hasResults":11,"nctId":301,"briefTitle":302,"officialTitle":302,"acronym":303,"eligibilityCriteria":304,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":305,"targetDuration":4,"studyType":23,"phases":306,"briefSummary":307,"conditions":308,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":46},"100326828","prognostic-significance-of-fatty-liver-disease-in-bariatric-patients-100326828","NCT03535142","Prognostic Significance of Fatty Liver Disease in Bariatric Patients","PROMETHEUS","Inclusion Criteria case group:\n\n* Age \\> 18 years\n* BMI \\>35 kg\u002Fm2 and referred for bariatric surgery at Hospital of South West Jutland, Denmark\n* Able to give written informed consent.\n\nInclusion criteria control group:\n\n* Age \\> 18 years\n* BMI \\>35 kg\u002Fm2 with no wish to undergo bariatric surgery.\n* Able to give written informed consent.\n\nExclusion Criteria:\n\n* Active viral hepatitis\n* Not willing or able to consent\n* Contraindications to liver biopsy",{"count":210,"type":22},[57],"Prospective non-randomized intervention case control study on patients with a BMI \\> 35. The intervention group\u002Fcases (n=600) is comprised of bariatric patients who undergo bariatric surgery and the control group (n=600) of age, weight and comorbidity matched patients who choose not to undergo bariatric surgery. The overall aim is to examine prevalence of the spectrum of fatty liver disease (NAFLD) in these patients and the prognostic significance of NAFLD.",[29,309,310,77],"Metabolic Encephalopathy","Obesity, Morbid","2025-03-03",{"date":313,"type":38},"2025-03-05",{"date":315,"type":38},"2018-08-15",{"date":317,"type":22},"2038-04-01",{"name":319,"class":100},"Esbjerg Hospital - University Hospital of Southern Denmark",{"id":321,"slug":322,"hasResults":11,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":4,"eligibilityCriteria":326,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":327,"enrollmentInfo":328,"targetDuration":4,"studyType":23,"phases":329,"briefSummary":331,"conditions":332,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":342},"100511906","phase-1-a-study-of-ini-822-in-healthy-volunteers-and-participants-with-non-alcoholic-steatohepatitis-nash-or-presumed-nash-100511906","NCT05945537","A Study of INI-822 in Healthy Volunteers and Participants with Non-alcoholic Steatohepatitis (NASH) or Presumed NASH","A Phase 1 Randomised, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of INI-822 in Healthy Volunteers and Participants with Non-alcoholic Steatohepatitis (NASH) or Presumed NASH","Inclusion Criteria:\n\n1. Females must not be pregnant or lactating, and must use acceptable, highly effective double contraception (see Section 7.3.1) from Screening until 90 days after their last dose of IP or 5 half-lives, whichever is longer. Females with same-sex partners (abstinent from penile-vaginal intercourse) or who are abstinent from heterosexual intercourse are not required to use contraception when this is their preferred and usual lifestyle. Women of childbearing potential (WOCBP) must have a negative pregnancy test at Screening and Day -1. Women not of childbearing potential must be postmenopausal for ≥ 12 months (postmenopausal status is to be confirmed through testing of follicle stimulating hormone \\[FSH\\] levels ≥ 40 IU\u002FL at Screening for amenorrhoeic female participants). Females must not donate ova from the first dose of IP until at least 90 days after the last dose of IP or 5 half-lives, whichever is longer.\n2. Males must be surgically sterile (\\> 30 days since vasectomy \\[documented evidence\\] with no viable sperm), or, if engaged in sexual relations with a WOCBP, they must use a condom and either his partner must be surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy), or an acceptable, highly effective contraceptive method (see Section 7.3.1) must be used from Day -1 until study completion. Males with same-sex partners (abstinent from penile-vaginal intercourse) or abstinent from heterosexual intercourse are not required to use contraception when this is their preferred and usual lifestyle. males must not donate sperm from the first dose of IP until at least 90 days after the last dose of IP or 5 half-lives, whichever is longer.\n3. Able and willing to attend the necessary visits to the study site.\n4. Able and willing to provide written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures.\n5. Normal renal function (estimated glomerular filtration rate \\> 60 mL\u002Fmin using Cockcroft-Gault).\n\n   For Parts A and B only:\n6. Clinical laboratory values within normal range at Screening and Day -1 and Day 7 (Part D), as specified by the testing laboratory, unless deemed not clinically significant by the Investigator or designee. Any laboratory values \\> upper limit of normal (ULN) at Screening should be discussed with the Sponsor, independent Medical Monitor (MM), or Investigator for approval prior to inclusion. Repeat testing at Screening is acceptable for out-of-range values following approval by the Investigator or designee. Inclusion of participants with laboratory values \\> ULN at Day -1 and Day 7 (Part D) will be at the Investigator's discretion.\n7. In good general health, with no significant medical history, and no clinically significant abnormalities on physical examination at Screening and\u002For before the first administration of IP, at the discretion of the Investigator or designee.\n8. Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg\u002Fm2 with a maximum body weight of 120 kg.\n9. 18 to 55 years of age (inclusive at the time of informed consent).\n10. Able and willing to refrain from use of tobacco and other nicotine-containing products while at the study site and through the study treatment period.\n\nFor Part C only:\n\n11.18 to 65 years of age (inclusive at the time of informed consent).\n\n12\\. A diagnosis of NASH confirmed by 1 or more of the following:\n\n1. Historical liver biopsy consistent with NASH (presence of Grade 1 steatosis, hepatocellular ballooning, and lobular inflammation) according to the non-alcoholic fatty liver disease (NAFLD) activity score.\n2. F0-3 fibrosis according to the NASH Clinical Research Network classification within 1 year of Screening.\n3. A clinical diagnosis of NASH, and the presence of any component of the metabolic syndrome (obesity, dyslipidemia, hypertension, elevated fasting glucose, or type 2 diabetes).\n4. FibroScan-aspartate aminotransferase (FAST) score more than equal to 0.35.\n\n   13\\. Alanine aminotransferase (ALT) \\> 1.00 × ULN at 2 separate time points in the past 6 months. At least 1 time point must be at Screening and the values must be at least 2 weeks apart. Patients with ALT values \\\u003C1.00 × ULN may be included in the study on a case-by-case basis after approval by the Sponsor.\n\n   14\\. Fibrosis-4 (FIB-4) score ≤ 2.67, controlled attenuation parameter (CAP) score by FibroScan® ≥ 280 Db\u002Fm, and liver stiffness measurement (LSM) by FibroScan® ≤ 14 kPa.\n\n   15\\. No documented weight loss \\> 5% in the 6 months preceding Screening.\n\n   16\\. If on glucagon-like peptide 1 (GLP1) agonists, sodium-glucose co-transporter 2 (SGLT2) inhibitors, or vitamin E (dose \\> 400 IU\u002Fday), then should have been on a stable dose for at least 3 months.\n\n   17\\. Platelet count \\> 150,000 and albumin ≥ 35 g\u002FL.\n\n   18\\. BMI ≥ 18.0 and ≤ 40.0 kg\u002Fm2\n\nExclusion Criteria:\n\nA participant who meets any of the following exclusion criteria must be excluded from the study:\n\n1. An underlying physical or psychological medical condition that, in the opinion of the Investigator, would make it unlikely for the participant to comply with the protocol or complete the study per protocol.\n2. Blood donation or significant blood loss (\\> 500 mL) within 60 days prior to the first administration of IP.\n3. Plasma donation within 7 days prior to the first administration of IP.\n4. Fever (body temperature \\> 37.7°C) or symptomatic viral or bacterial infection within 2 weeks prior to Day 1.\n5. Dysphagia that would limit ability to swallow IP.\n6. History of severe allergic or anaphylactic reactions, or sensitivity to the IP or its constituents. The excipients in the IP are: Hydroxypropylmethylcellulose Acetate Succinate (HPMCAS), Microcrystalline Cellulose, Micronized Poloxamer 407 (polyoxyethylene oxide), Croscarmellose Sodium, Silicon Dioxide, Magnesium Stearate, and Hydroxypropylmethylcellulose capsules containing Titanium Oxide.\n7. Abnormalities in physical examination at Screening and Day -1 which are deemed clinically significant by the Investigator or designee.\n8. Abnormal electrocardiogram (ECG) measurements at Screening (an average of 3 readings) and Day -1 (single reading) that are considered by the Investigator or designee to be clinically significant, including corrected QT interval with Fridericia's correction (QTcF) \\> 450 msec (males) or \\> 470 msec (females).\n9. Unstable vital sign(s) or the following values seen at Screening or prior to dosing following 5 minutes of resting in the semi-supine position (an abnormal value may be repeated once, separated by at least 5 minutes, with both values documented):\n\n   1. Systolic blood pressure \\\u003C 90 mmHg or \\> 160 mmHg OR\n   2. Diastolic blood pressure \\\u003C 50 mmHg or \\> 95 mmHg OR\n   3. Pulse rate \\\u003C 45 beats per minute (bpm) or \\> 100 bpm.\n10. History or presence of other causes of liver disease including genetic, autoimmune, viral, and alcoholic liver disease.\n11. Cirrhosis of the liver as defined by:\n\n    1. A prior history of decompensated liver disease, including ascites, hepatic encephalopathy, or variceal bleeding OR\n    2. F4 on previous liver biopsy OR\n    3. Historical evidence of cirrhosis on liver imaging.\n12. History of major hospitalisation or major surgery within 6 months prior to Screening. Sites are encouraged to confirm with the Sponsor or Medical Monitor if there are any questions on what would be considered major hospitalization or major surgery.\n13. Infections requiring parenteral antibiotics within 6 months prior to Screening.\n14. Vaccination with a live vaccine within 4 weeks prior to the first administration of IP.\n15. Exposure to any significantly immune suppressing drug (including experimental therapies as part of a clinical study) within 4 months prior to Screening or 5-half lives, whichever is longer.\n16. Positive blood screen for active infections including human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) at Screening.\n17. History of substance abuse or dependency or history of recreational intravenous drug use over the last 12 months (by self-declaration).\n18. Use of any IP or investigational medical device within 30 days for small molecules (or 5 half lives of the IP if longer than 30 days) or 90 days for biologics prior to first IP administration.\n19. Anything that the Investigator considers would jeopardise the safety of the participant, prevent complete participation in the study, or compromise interpretation of study data.\n20. Bariatric surgery.\n21. Cardiovascular disease including heart failure with reduced left ventricular ejection fraction, atrial fibrillation requiring anticoagulation, or any other cardiovascular illness that, in the opinion of the Investigator, warrants exclusion from the study.\n\n    For Parts A and B only:\n22. Use of (or anticipated use of) any prescription drugs (other than hormonal contraception; oral contraceptive pills \\[OCPs\\], long-acting implantable hormones, injectable hormones, or an intrauterine device \\[IUD\\]), any known drugs or supplements that are moderate or strong inhibitors\u002Finducers of cytochrome P450 (CYP) enzymes, over-the-counter (OTC) medication, herbal remedies, supplements or vitamins within 48 hours of IP administration and during the course of the study without prior approval of the Investigator and independent MM. Simple analgesia (paracetamol \\\u003C 2 g\u002Fday) may be permitted at the discretion of the Investigator.\n23. Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, haematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity, as determined by the Investigator.\n24. History of or suspected malignancy. Participants with basal or squamous cell carcinoma of the skin or carcinoma in situ that has been successfully treated could be included at the discretion of the Investigator or designee.\n25. Positive toxicology screening panel (urine test including Methamphetamine, Opiates, Cocaine, tetrahydrocannabinol, Phencyclidine, Benzodiazepines, Barbiturates, Methadone, tricyclic antidepressants and Amphetamine), or alcohol breath test at Screening or Day -1\n26. History of alcohol use disorder (within 9 months prior to Screening by self-declaration) or habitual consumption of significant amounts of alcohol (by self-declaration), defined as \\> 10 standard drinks per week or \\> 4 standard drinks on any single day (where 1 standard drink = 360 mL of beer, 45 mL of 40% spirit, or a 150 mL glass of wine). Participants who are unable to abstain from alcohol 72 hours prior to Screening and Day -1 visits and until study completion are to be excluded.\n\n    For Part C only:\n27. ALT ≥ 5 × ULN; AST\\>ALT. If ALT ≤ ULN, then AST may be greater than the ALT if it is also ≤ ULN.\n28. Use of (or anticipated use of) any known drugs or supplements that are moderate or strong inhibitors\u002Finducers of CYP enzymes or any drugs that are substrates of CYP2C9 with a narrow therapeutic index (e.g., warfarin or other coumarin based anticoagulants, phenytoin, celecoxib, glimepiride, tolbutamide or phenobarbital or other drugs metabolised by CYP2C9) or any oral drugs that are significantly metabolised by CYP3A4 (e.g., alfentanil, apixaban, avanafil, buspirone, cyclosporine, dihydroergotamine, ergotamine, fentanyl, oxybutinin, losartan, lomitapide, lovastatin, midazolam, naloxegol, nisoldipine, pimozide, quinidine, sildenafil, simvastatin, sirolimus, tadalafil, tamsulosin, tacrolimus and zopiclone), during the course of the study. Prescription medications for stable medical condition may be allowable if the Investigator considers they will not interfere with the study; the independent MM may be contacted to discuss any particular medications.\n29. Participants with uncontrolled medical conditions; the independent MM may be contacted for discussion.\n30. History of significant cardiovascular disease, including cardiac failure, myocardial infarction, unstable angina, stroke or transient ischaemic attack within 6 months prior to the first dose of IP.\n31. Uncontrolled diabetes mellitus (haemoglobin A1c \\[HbA1c\\] \\> 9.0% at Screening).\n32. Malignancy within the last 5 years; basal or squamous cell carcinoma of the skin or carcinoma in situ that has been successfully treated could be included at the discretion of Investigator or designee.\n33. History or presence of a condition associated with significant immunosuppression.\n34. Positive toxicology screening panel (urine test including Methamphetamine, Opiates, Cocaine, tetrahydrocannabinol, Phencyclidine, Benzodiazepines, Barbiturates, Methadone, and Amphetamine) at Screening or Day -1. A positive toxicology screening that is explained by a prescribed medication is allowable.\n35. History of alcohol use disorder (within 9 months prior to Screening by self-declaration) or habitual consumption of significant amounts of alcohol (by self-declaration), defined as \\> 10 standard drinks per week or \\> 4 standard drinks in a day (where 1 standard drink = 360 mL of beer, 45 mL of 40% spirit, or a 150 mL glass of wine). Participants who are unable to abstain from alcohol 72 hours prior to Screening and Day -1 visits are to be excluded. Participants unable to consume 10 standard drinks or fewer in a week or 2 standard drinks in a day or fewer during the study are to be excluded.","65 Years",{"count":21,"type":22},[330],"PHASE1","This Phase 1 trial will explore the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple ascending doses of INI-822 in healthy volunteers in Parts A, B, and D and in participants with a history of NASH or presumed NASH in Part C.",[77],"2025-02-03",{"date":335,"type":38},"2025-02-05",{"date":337,"type":38},"2023-09-08",{"date":339,"type":22},"2025-06-15",{"name":341,"class":125},"Inipharm Australia Pty Ltd",7,{"id":344,"slug":345,"hasResults":11,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":349,"eligibilityCriteria":350,"healthyVolunteers":11,"sex":17,"minAge":351,"maxAge":352,"enrollmentInfo":353,"targetDuration":4,"studyType":23,"phases":355,"briefSummary":356,"conditions":357,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":46},"100476189","phase-2-soluble-fibre-supplementation-in-nafld-100476189","NCT05480696","Soluble Fibre Supplementation in NAFLD","The Efficacy of Soluble Fibre Supplementation for the Treatment of Pediatric Non-alcoholic Fatty Liver Disease (NAFLD)","FIND","Inclusion Criteria:\n\n* Children ages 8-17 years\n* Diagnosed with obesity (BMI ≥2 standard deviations above WHO reference median)\n* Enrolled in GHWM Clinic\n* Clinical evidence of NAFLD (elevation of ALT, greater than 2x upper-limit-of-normal (ULN) \\[ALT\\>80 IU\u002FL for 8-17 years of age\\], and hepatic steatosis measured as part of clinic enrolment).\n\nExclusion Criteria:\n\n* Type 1, Type 2 diabetes mellitus (T1DM, T2DM)\n* Contraindications to having MRI (claustrophobia, metal implant, recent tattoo, weight \\> 300lbs)\n* Concomitant use of other fibre supplements\n* Medications known to affect hepatic fat content, taken within the past year (i.e., glucocorticoids, anabolic steroids, tetracycline, anticonvulsants, antipsychotics, glucose- lowering medications)\n* Presence of another known cause of liver disease\n* Known allergy or hypersensitivity to OF-INU supplementation\n* Self-reported alcohol intake \\>7 drinks\u002Fweek or 3 drinks\u002Fday","8 Years","17 Years",{"count":354,"type":22},60,[25],"The FIND study will look at the effect of a nutritional mixed fibre supplement, oligofructose and inulin (OF+INU), on children with non-alcoholic fatty liver disease. In this randomized, double- blind controlled trial, subjects will be given a supplement, in the form of oral pills, and will have bloodwork performed, their diets analyzed, and liver fat measured at several timepoints. Liver fat will be measured by using a specialized MRI device located at St. Joseph's Hospital. Subjects will be recruited from the Children's Exercise and Nutrition Clinic.",[29,266,358],"Hepatic Steatosis","2024-11-08",{"date":361,"type":38},"2024-11-12",{"date":363,"type":38},"2022-09-09",{"date":365,"type":22},"2027-03",{"name":367,"class":100},"McMaster University",{"id":369,"slug":370,"hasResults":11,"nctId":371,"briefTitle":372,"officialTitle":373,"acronym":4,"eligibilityCriteria":374,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":327,"enrollmentInfo":375,"targetDuration":4,"studyType":23,"phases":377,"briefSummary":378,"conditions":379,"keywords":380,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":46},"100568099","effect-of-alternate-day-fasting-over-standard-medical-management-alone-to-reverse-non-alcoholic-steatohepatitis-100568099","NCT06676813","Effect of Alternate Day Fasting Over Standard Medical Management Alone to Reverse Non-alcoholic Steatohepatitis.","Effect of Alternate Day Fasting Over Standard Medical Management Alone to Reverse Non-alcoholic Steatohepatitis(NASH), A Randomized Controlled Trial. FAST Trial\"","Inclusion Criteria:\n\n* Age 18-65 years. BMI 25-40kg\u002Fm3, and CAP more than 290\n* Stable weight in the last 3 months prior to enrolling in the study(\\\u003C5kg weight variation)\n* Imaging showed steatotic liver disease, liver stiffness \\\u003C14kPa measured by fibroscan\n* Histologically proven NASH\u002FMASH, fibrosis up to F3\n* Subjects willing to participate in the study\n\nExclusion Criter\n\n* Liver stiffness \\>14kPa measured by fibroscan or Fibrosis \\>F3\n* Diabetes with HbA1c\\>8.5%\n* Patients with another co-existing active liver disease e.g. hepatitis B or C, alcoholic liver disease\n* Patients with cirrhosis, hepatocellular carcinoma(HCC), or other malignancy\n* Chronic kidney disease, cardiovascular disorders, uncontrolled hypertension\n* Chronic infections, chronic inflammatory diseases\n* Patients on weight loss medications e.g semaglutide\n* Pregnant or lactating women and those planning a pregnancy A patient who is not willing to participate in the study or failed to provide the consent",{"count":376,"type":22},72,[57],"The aims of this study are as follows: To compare the role of alternate-day fasting over standard medical management alone to reverse NASH.",[266],[381,382,67,383,267],"Alternate day fasting.","NASH","Steatotic liver disease","2024-11-05",{"date":386,"type":38},"2024-11-07",{"date":388,"type":38},"2024-07-01",{"date":390,"type":22},"2025-06-30",{"name":392,"class":100},"Institute of Liver and Biliary Sciences, India",{"id":394,"slug":395,"hasResults":11,"nctId":396,"briefTitle":397,"officialTitle":397,"acronym":398,"eligibilityCriteria":399,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":109,"enrollmentInfo":400,"targetDuration":4,"studyType":23,"phases":402,"briefSummary":403,"conditions":404,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":413,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":46},"100502342","phase-2-synbiotics-and-fecal-microbiota-transplantation-to-treat-non-alcoholic-steatohepatitis-100502342","NCT05821010","Synbiotics and Fecal Microbiota Transplantation to Treat Non-Alcoholic Steatohepatitis","SYNCH","Inclusion Criteria:\n\n* biopsy-proven NASH obtained up to 32 weeks before screening: SAF Steatosis score ≥1, Activity ≥2, Fibrosis \\\u003C4; 50% of participants should at least have NASH fibrosis stage 1, 2 or 3 according to the NASH CRN fibrosis staging system based on tandem reading of two expert liver pathologists\n* fluency in Dutch or English\n* participants should be able to understand the information and give informed consent\n\nExclusion Criteria:\n\n* Current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year before screening (significant alcohol consumption is defined as more than 2 international units\u002Fday for females and more than 3 international units\u002Fday for males, on average; 1 international unit contains ±14 grams of alcohol)\n* liver cirrhosis or hepatocellular carcinoma\n* hepatitis B and\u002For C\n* auto-immune hepatitis\n* Wilson's disease\n* primary sclerosing cholangitis\n* primary biliary cholangitis\n* alpha-1-antitripsine deficiency and hemochromatosis\n* history of liver transplant, current placement on a liver transplant list\n* use of pre-, pro- or synbiotics\n* use of systemic antibiotics 3 month prior to randomization\n* use of tamoxifen, methotrexate or amiodarone\n* prior or planned bariatric surgery\n* active GLP-1 receptor agonist treated diabetes mellitus\n* bleeding disorder\n* International normalized ratio (INR) of prothrombin time \\>1.4 or platelet count \\\u003C100 109\u002FL at screening\n* anti-platelet\u002Fcoagulant therapy use which cannot be temporarily discontinued\n* any major cardiovascular event within 6 months prior to screening (e.g. myocardial infarction, cerebrovascular accident)\n* prolonged compromised immunity (e.g. recent cytotoxic chemotherapy, HIV-infection with a CD4 count \\\u003C 240)\n* active or prior history of invasive malignancy (except for curatively treated in situ carcinomas \\[e.g., cervix\\] or non-melanoma skin cancer) unless a complete remission was achieved\n* surgery scheduled for the trial duration period, except for minor surgical procedures, in the opinion of the investigator\n* pregnant or nursing women\n* any condition which, in the investigator's opinion, might jeopardize participants' safety or compliance with the protocol\n* participation in another concomitant clinical trial.",{"count":401,"type":22},48,[25],"The goal of this clinical trial is to investigate the therapeutic potential of A. soehngenii and pasteurized A. muciniphila combined with B. animalis subsp. lactis and fructo-oligosaccharides with and without conditioned vegan lyophilized fecal microbiota transplantation capsules to reduce NASH in patients with fibrotic NASH. The main questions to answer are:\n\n1. Can NASH be treated by altering the gut microbiota using LFMT capsules?\n2. Can NASH be treated using a syntrophic cocktail of synbiotics and will these strains strengthen the effect of FMT?\n3. What are the underlying mechanism by which the aforementioned treatments attenuate NASH?\n\nParticipants will be treated with FMT-capsules or placebo, and all participants will receive a cocktail of 3 strains of probiotics and one type of prebiotic.",[266,29,405,406,407,408,409,410,411],"Fecal Microbiota Transplantation","FMT","Prebiotics","Probiotics","Microbiome","Intestinal Microbiome","Gut Microbiome","2024-08-26",{"date":414,"type":38},"2024-08-27",{"date":416,"type":38},"2023-03-17",{"date":418,"type":22},"2026-08-20",{"name":420,"class":100},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)",{"id":422,"slug":423,"hasResults":11,"nctId":424,"briefTitle":425,"officialTitle":426,"acronym":4,"eligibilityCriteria":427,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":109,"enrollmentInfo":428,"targetDuration":4,"studyType":23,"phases":430,"briefSummary":431,"conditions":432,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":434,"startDateStruct":435,"completionDateStruct":437,"leadSponsor":439,"locationsCount":441},"100559852","phase-2-efficacy-and-safety-of-recombinant-human-fgf21-fc-fusion-protein-for-injection-tqa2225ap025-in-adult-subjects-with-non-alcoholic-steatohepatitis-nash-100559852","NCT06569524","Efficacy and Safety of Recombinant Human FGF21-Fc Fusion Protein for Injection (TQA2225\u002FAP025) in Adult Subjects With Non-alcoholic Steatohepatitis (NASH)","A Double-blind, Placebo Randomized，Phase II Study to Evaluate the Efficacy and Safety of TQA2225\u002FAP025 in Adults With Nonalcoholic Steatohepatitis (NASH)","Inclusion Criteria:\n\n* Must be willing to participate in the study and provide written informed consent.\n* Male or female aged 18 ≤ age \\\u003C 75 at the time of signing the informed consent.\n* Must have had prior liver biopsy within 180 days of randomization with fibrosis stage 1 to 3 and a NAS of ≥4 with at least a score of 1 in each of the lobular inflammation and ballooning degeneration.\n* Confirmation of ≥10% liver fat content on Magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF).\n* Weight changes≤5% in the 6 weeks prior to randomization.\n* No qualitative change in dose for the drugs listed below:\n\n  1. Antidiabetic treatment if glucagon-like peptide-1 receptor agonists (GLP1 receptor agonists) or sodium-glucose co-transporter-2 inhibitors (SGLT2 inhibitors): for at least 3 months\n  2. Vitamin E (if at a dose ≥400 IU\u002Fday): for at least 6 months\n  3. Statins: for at least 3 months\n* Females of childbearing potential must practice a consistent and proper use of highly effective method of contraception throughout the study and for 6 month after treatment discontinuation.\n\nExclusion Criteria:\n\n* Documented causes of chronic liver disease other than NASH\n* Type 1 diabetes or uncontrolled Type 2 diabetes defined as:Hemoglobin A1c ≥9% at screening，Fasting blood glucose≥13.9mmol\u002Fl\n* Uncontrolled hypertension at Screening (values ≥160\u002F100 mm Hg)\n* History or presence of cirrhosis\n* Subjects with any type of active malignancy or a history of malignancy (except cervical cancer or non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma and papillary thyroid carcinoma) that has been cured for more than 5 years prior to the screening period;\n* Unable or unwilling to undergo liver biopsy according to research requirements.\n* History of weight loss surgery within 5 years (inclusive) prior to screening\n* A major surgery was performed 3 months prior to signing the Informed Consent Form (ICF), or planned during the study period.\n* Have experienced any bone trauma, fracture, or bone surgery within ≤ 2 months prior to screening.\n* When screening, according to the results of dual energy X-ray absorptiometry (DXA) examination, it meets the criteria for osteoporosis: T≤ -2.5\n* Recent history of drug abuse (defined as ≤ 2 years).\n* Patient participating in other clinical trials of drugs or medical devices within 3 months prior to screening.\n* Abnormal laboratory test values：ALT or AST \\>5 × ULN；Serum ALP≥2× ULN；eGFR\\\u003C60mL\u002Fmin；INR\\>1.3× ULN；platelets \\\u003C LLN.\n* Pregnant or breastfeeding women.\n* Liver transplantation history or planned liver transplantation\n* Contraindications for MRI examination\n* Any other condition which, in the opinion of the Investigator, would impede compliance, hinder completion of the study, compromise the well-being of the patient, or interfere with the study outcomes.",{"count":429,"type":22},120,[25],"A randomized, double-blind, placebo-controlled Phase II study，to evaluate the efficacy and safety of TQA2225\u002FAP025 in Patients With Non-Alcoholic Steatohepatitis (NASH)",[77],"2024-08-22",{"date":412,"type":38},{"date":436,"type":38},"2023-09-14",{"date":438,"type":22},"2027-12",{"name":440,"class":125},"Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.",53,{"id":443,"slug":444,"hasResults":11,"nctId":445,"briefTitle":446,"officialTitle":447,"acronym":448,"eligibilityCriteria":449,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":450,"targetDuration":4,"studyType":23,"phases":451,"briefSummary":452,"conditions":453,"keywords":4,"overallStatus":454,"whyStopped":4,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":456,"startDateStruct":458,"completionDateStruct":460,"leadSponsor":462,"locationsCount":4},"100528400","phase-2-study-of-liver-fibrosis-stage-assessment-by-fibroblast-activation-protein-imaging-in-patients-with-biopsy-for-suspected-or-proven-nonalcoholic-steatohepatitis-100528400","NCT06160271","Study of Liver Fibrosis Stage Assessment by Fibroblast Activation Protein Imaging in Patients With Biopsy for Suspected or Proven Nonalcoholic Steatohepatitis","Pilot Study of Liver Fibrosis Stage Assessment by Tep Fibroblast Activation Protein Imaging (68Ga-FAPI-46 TEP\u002FTDM) in Patients With Biopsy for Suspected or Proven Nonalcoholic Steatohepatitis (NASH)","HEFITEP","Inclusion Criteria:\n\n1. Individuals with recent liver biopsy for suspected or confirmed NASH\n2. Individuals of legal age, who have received full information on the organization of the research and have signed an informed consent form.\n3. Person, affiliated to a social security scheme or beneficiary of such a scheme.\n4. Person who has undergone a preliminary clinical examination appropriate to the research.\n5. Histological stage of fibrosis obtained at biopsy in accordance with the planned numbers (an equivalent number of patients with histological stages \\>2 and ≤ 2 must be recruited in each center, and a number of at least 16 patients must be included by all centers in each of the 4 groups of histological stages of fibrosis).\n\nExclusion Criteria:\n\n1. Known hypersensitivity to 68Ga-FAPI-46 or to any of the excipients or components of the radiopharmaceutical.\n2. Infection with HCV\u002FHBV.\n3. Decompensated cirrhosis (ascites, hepatic insufficiency, hepatorenal syndrome, etc.).\n4. Known hepatocellular carcinoma.\n5. Steatogenic treatment (corticosteroid, Tamoxifen, Amiodarone, Methotrexate).\n6. Excessive alcohol consumption in the last 5 years (\\>210 g\u002Fweek in men, \\>140 g\u002Fweek in women).\n7. Clinically unstable state not suitable for 68Ga-FAPI-46 PET\u002FCT scan.",{"count":376,"type":22},[25],"Non-alcoholic fatty liver disease (NAFLD), estimated to be 17% prevalent in France, can lead to non-alcoholic steatohepatitis (NASH), which in turn can progress to fibrosis, the ultimate stage of which is cirrhosis, a major cause of liver transplantation. The prevalence of NASH is increasing worldwide, along with that of type 2 diabetes and obesity. Significant liver fibrosis is estimated to affect at least 2.6% of the adult population in France.\n\nThe prognosis of patients with NASH is directly linked to the stage of liver fibrosis determined by biopsy, and these biopsies must now be repeated to assess the effect of treatments. Hepatic fibrosis is traditionally classified into five stages, from the absence of fibrosis (F0) to severe cirrhosis (F4), and passage from one stage to another is considered to demonstrate significant variation, likely to impact prognosis.\n\nHowever, liver biopsy is painful. It can only analyze a very small proportion of liver volume (1\u002F50,000), whereas the distribution of fibrosis is generally heterogeneous. Above all, biopsy is not devoid of risks, primarily hemorrhage, which can sometimes be severe or even fatal.\n\nIn line with current recommendations, clinical-biological algorithms, as well as ultrasound elastography or MRI, are used to assess the risk of fibrosis and the value of a liver biopsy. Generally speaking, these tests have the advantage of very good negative predictive values, making it possible to exclude the possibility of significant fibrosis in a large proportion of patients. However, their positive predictive values are weaker, even when these tests are combined. Above all, they do not allow us to follow the evolution of the fibrosis stage over time. This is why liver biopsies remain indispensable for determining the stage and severity of hepatic fibrosis and monitoring its evolution. It is therefore essential to develop more precise, non-invasive methods for accurately assessing the extent of liver fibrosis. This is the objective of the FreSH national cohort, which uses conventional biological techniques and in which our patients will also be included.",[77],"NOT_YET_RECRUITING","2024-02-08",{"date":457,"type":38},"2024-02-09",{"date":459,"type":22},"2024-09-01",{"date":461,"type":22},"2027-06-01",{"name":463,"class":100},"Central Hospital, Nancy, France",{"id":465,"slug":466,"hasResults":11,"nctId":467,"briefTitle":468,"officialTitle":469,"acronym":470,"eligibilityCriteria":471,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":472,"targetDuration":474,"studyType":112,"phases":4,"briefSummary":475,"conditions":476,"keywords":477,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":481,"lastUpdatePostDateStruct":482,"startDateStruct":484,"completionDateStruct":486,"leadSponsor":488,"locationsCount":490},"100377155","european-paediatric-non-alcoholic-fatty-liver-disease-registry-eu-pnafld-100377155","NCT04190849","European Paediatric Non-Alcoholic Fatty Liver Disease Registry (EU-PNAFLD)","The European Paediatric Non-alcoholic Fatty Liver Disease Registry (EU-PNAFLD): a Prospective, Longitudinal Follow-up of Children With Non-alcoholic Fatty Liver Disease","EU-PNAFLD","Inclusion Criteria:\n\n* Diagnosis made under 18 years of age.\n* Diagnosis of NAFLD spectrum disease (simple steatosis (NAFL), steatosis with abnormal transaminases, NASH ± fibrosis or cirrhosis)\n* Diagnosis established by:\n\n  * Radiological evidence of hepatic steatosis (e.g. increased hepatic echogenicity on ultrasound), with\n  * Exclusion of secondary causes (negative serological liver screen for HBV\u002FHCV, caeruloplasmin \\>0.20g\u002FL, no history of excess alcohol consumption, no evidence of iron overload, and no clinically significant alpha-1 antitrypsin (A1AT) phenotype (i.e. SZ, ZZ, SS), with or without\n  * Histology (\\>5% steatosis and histology consistent with paediatric NAFLD)\n\nExclusion Criteria:\n\n* Secondary fatty liver disease (e.g. glycogen storage diseases, Wilson disease, viral hepatitis, drug-related, autoimmune hepatitis, type 1 diabetes mellitus)\n* Post-transplant fatty liver\n* \\>20g\u002Fday ethanol intake",{"count":473,"type":22},2000,"30 Years","The EU-PNAFLD (The European Paediatric NALFD Registry) will be a network composed of European centres involved in the care of children with NAFLD, and will include Hepatologists, Endocrinologists, and Scientists, supported by relevant international specialists. This collaboration will build on existing infrastructure (local databases and bio-repositories) and will align with the adult European NAFLD Registry (\"EPoS\", Elucidating Pathways of Steatohepatitis study) to allow long-term follow-up supported by translational studies. Through an international, well-characterised large-scale cohort, we hope to: facilitate multi-centre clinical trials; extend our understanding of the key disease mechanisms of NAFLD; and establish the natural history of paediatric NAFLD.",[29,115,77],[267,189,478,479,480],"Hepatocellular carcinoma","Type 2 diabetes","Atherosclerosis","2022-02-17",{"date":483,"type":38},"2022-03-04",{"date":485,"type":38},"2017-11-14",{"date":487,"type":22},"2047-11",{"name":489,"class":100},"Cambridge University Hospitals NHS Foundation Trust",3]