[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"steatotic-liver-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:steatotic-liver-disease":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,101],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100613763","screening-for-masld-related-advanced-fibrosis-in-type-2-diabetes-100613763",false,"NCT07270822","Screening for MASLD-related Advanced Fibrosis in Type 2 Diabetes","Implementation of a Systematic Screening for MASLD-related Advanced fibrosiS for Patients With Type 2 Diabetes folLoweD by DIABetologists","MASLD-DIAB","Inclusion Criteria:\n\n* Adult patient, male or female\n* Type 2 diabetic patient, followed by a diabetologist in private practice participating in the study\n* Patient affiliated to a French or European healthcare insurance\n* Patient who agrees to be included in the study and who signs the informed consent form\n\nExclusion Criteria:\n\n* Evidence of advanced fibrosis (F3 or F4 fibrosis based on the results from previous liver biopsy F3 ou F4 or evidence of cirrhosis).\n* Evidence of other causes of chronic liver disease\n* Patient who does not understand French\u002F is unable to give consent,\n* Patient already included in a trial who may interfere with the study\n* The subject is a pregnant or nursing female\n* Minor patient\n* Patient deprived of liberty,\n* Patient admitted to a health or social establishment for purposes other than research\n* Mentally unbalanced patients, under supervision or guardianship,\n* Patient undergoing psychiatric care\n* Patient not affiliated to a healthcare insurance plan\n* Patient already included in this screening program in the previous 12 months","ALL","18 Years",{"count":20,"type":21},1714,"ESTIMATED","INTERVENTIONAL",[24],"NA","Metabolic dysfunction-associated steatotic liver disease (MASLD) affects approximately 25% of the global adult population, 25-30% of whom suffer from metabolic dysfunction-associated steatohepatitis (MASH), increasing the risk of progression to advanced fibrosis (AF) (fibrosis stage F3 or cirrhosis F4). Screening for AF is justified because it is associated with an increased risk of overall, hepatic, and cardiovascular mortality and therefore constitutes a public health issue.\n\nPatients with type 2 diabetes (T2D) are identified as a priority target for screening because they are at high risk of AF related to MASLD. The recommendations of the French Association for the Study of the Liver 2020 (afef.asso.fr), the European Association for the Study of the Liver (2024), the American Association of Clinical Endocrinology (2022), and the American Association of Diabetes (2025) all recommend a two-step screening process involving the FIB-4 biological score, followed by transient elastography (TE) if the FIB-4 score is \\> or = 1.30. Finally, if the TE is ≥8 kPa, the patient is considered to be at intermediate\u002Fhigh risk of AF requiring specialized care to confirm the diagnosis and implement appropriate management, including semi-annual screening for hepatocellular carcinoma in cases of cirrhosis Despite these recommendations, their application in clinical practice remains difficult and requires multidisciplinary collaboration between diabetologists and hepatologists, and between community and hospital sectors, particularly to access TE measures.\n\nSince 2018, the Lyon Sud diabetes department (Hospices Civils de Lyon) has implemented an in-hospital AF screening program using TE for T2D patients. However, this screening by private diabetologists has not yet been implemented, mainly due to the lack of a standardized care pathway and difficulty in accessing TE measurements.\n\nHYPOTHESIS The implementation of systematic and standardized AF screening in private diabetes practices, in two stages and using ET in diabetes care in accordance with recommendations, would significantly increase the identification of patients with AF and thus improve their access to specialized services and appropriate care.",[27,28],"Steatotic Liver Disease","Fibrosis of Liver",[30,31,32,33,34,35],"Metabolic dysfunction-associated steatotic liver disease","hepatic transient elastography","hepatic fibrosis","type 2 diabetes mellitus","screening","non-invasive tests","NOT_YET_RECRUITING","2026-04-02",{"date":39,"type":40},"2026-04-03","ACTUAL",{"date":42,"type":21},"2026-05-01",{"date":44,"type":21},"2029-03-01",{"name":46,"class":47},"Hospices Civils de Lyon","OTHER",10,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":63,"conditions":64,"keywords":72,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":100},"100579393","phase-1-rtx001-autologous-engineered-macrophages-for-liver-cirrhosis-100579393","NCT06823713","RTX001 Autologous Engineered Macrophages for Liver Cirrhosis","An Open-label Phase 1\u002F2 Multicentre Study to Evaluate the Safety, Tolerability and Efficacy of RTX001 Autologous Macrophages in Participants With Liver Cirrhosis Who Have Hepatic Decompensation (EMERALD)","EMERALD","Individuals eligible to participate in this study must meet the following criteria:\n\nInclusion Criteria:\n\n1. Male or female age ≥18-75 years.\n2. Patient confirms willingness\u002Fability to comply with all study procedures.\n3. Diagnosis of liver cirrhosis based on at least one of:\n\n   1. Clinical and radiological features that correlate with a diagnosis of cirrhosis.\n   2. Transient elastography (Fibroscan) \\>15 kPa.\n   3. Previous liver biopsy confirming histological features of cirrhosis.\n4. Aetiology of liver disease of steatotic liver disease including MASLD or Met-ALD or ALD\n\n   a. Participants with alcohol-related liver disease (ALD or Met-ALD) only if they are confirmed to not be drinking alcohol above Met-ALD limits defined in this protocol. (N.B. No more than 34% of the total treated participants in this protocol will be ALD \\[excludes Met-ALD\\]).\n5. Hospitalised as an inpatient for a recent major hepatic decompensation event including ascites, hepatic encephalopathy, variceal bleed, HRS-AKI or SBP, this being the only hospitalisation for an hepatic decompensation event hospitalisation within the last 6 months, and where recent is defined as within 6 weeks of hospital discharge.\n6. Outpatient: Medically refractory ascites (ONLY), that recurs (i.e., second therapeutic LVP) within a 6-month period. Medically refractory ascites is defined by the repeated (≥2) need for LVP (i.e., therapeutic, not diagnostic) at least once per 8 weeks despite best medical attempts to control the ascites by sodium restriction and diuretic treatment, as confirmed by the Investigator. Onset is defined as the date of the second therapeutic LVP.\n7. Confirmatory PEth alcohol test \\\u003C200 ng\u002Fml\n8. MELD score of 12-20 taken within two weeks of 'qualifying' decompensation event.\n9. No known contradictions to filgrastim or leukapheresis procedure.\n10. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n11. Willing and able to give signed informed consent, and if applicable assent.\n\nParticipants are excluded from the study if any of the following criteria apply:\n\nExclusion Criteria:\n\n1. Liver cirrhosis due to:\n\n   1. any viral hepatitidies, or\n   2. autoimmune and cholestatic aetiologies including, but not limited to, primary biliary cholangitis and primary sclerosing cholangitis.\n2. Acute liver disease in the absence of underlying liver cirrhosis, including, but not limited to, drug induced liver injury.\n3. Any current organ failure requiring more than outpatient supportive care, and not associated with the participant's qualifying hepatic decompensation event.\n4. Known splenomegaly ≥16 cm.\n5. Thrombocytopenia \\\u003C50×109\u002FL.\n6. Presence or suspicion of any of the following co-morbidities:\n\n   1. History of liver transplantation or other organ transplant.\n   2. ACLF.\n   3. Sepsis (with positive microbial cultures) or as defined by the Principal Investigator, unless stable and is at least 4 weeks after having completed a full course of IV antibiotics.\n   4. Known human immunodeficiency virus.\n   5. Known syphilis.\n   6. Known human T-lymphotropic virus 1.\n   7. Pulmonary embolism.\n   8. Hepatocellular carcinoma, or any active malignant disease within the last five years, (excluding non-melanoma skin cancer, cervical carcinoma in situ, superficial bladder cancer, benign polyps etc.).\n   9. Co-hepatic morbidities e.g., portal vein thrombosis.\n   10. Participants with hepatic hydrothorax are excluded unless it is a small hydrothorax, not clinically apparent, that is detected incidentally by radiologic evaluation that does not require clinical intervention.\n   11. Chronic renal impairment (on dialysis) or unresolved AKI.\n   12. Acute or chronic heart failure (New York Heart Association Grade III\u002FIV).\n   13. Porto-pulmonary hypertension.\n   14. Severe chronic lung disease e.g., chronic obstructive pulmonary disease or interstitial lung disease where the forced expiratory volume in the first second (FEV1) is less than 50% and\u002For FEV1\u002Fforced vital capacity is less than 60%.\n   15. Hepatopulmonary syndrome.\n   16. Previous or current treatment with multiple infusions of albumin for therapeutic intent. \\[Use of albumin infusion at the time of large volume paracentesis for circulatory support is allowed.\\]\n   17. Significant untreated\u002Funstable psychiatric disease.\n   18. Transjugular intrahepatic portosystemic shunt (TIPSS).\n7. As judged by the Investigator, any evidence of intercurrent illness that is either life threatening or of clinical significance such that it might limit compliance with study procedures.\n8. Current or planned use of immunomodulators or immunosuppressive medication; note: low doses of corticosteroids up to 10 mg\u002Fkg\u002Fday prednisone or equivalent are permitted, or inhaled steroids to manage asthma.\n9. Received a gene or cell therapy at any time.\n10. Current or planned use of a live attenuated vaccines four weeks or fewer prior to enrolment (and for 3 months after the last administered dose of RTX001).\n11. Received any investigational product within the past 6 months, or five half-lives (whichever is longer) or participated in another investigational interventional study within 30 days prior to the screening visit.\n12. Participants with a known hypersensitivity to dimethyl sulfoxide (DMSO).\n13. Judgment by the Investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions and requirements.\n14. For female participants only - pregnant or breast-feeding or plans to become pregnant over the next year, or of childbearing potential and unwilling to comply with contraceptive requirements.\n15. Alcohol misuse in the period between identification of the participant as potentially suitable for this study to Screening (Visit 1), defined as alcohol intake greater than three units\u002Fday for females and four units\u002Fday for males, or binge drinking (\\>14 units\u002Fday) as determined by the Investigator. N.B. One unit is equivalent to 14 g of alcohol: a half-pint (\\~240 mL) of beer, one glass (125 mL) of wine or one (25 mL) measure of spirits.\n16. Intake of non-medically supervised drugs of abuse that are judged (by the Investigator) to be a high risk to the participants acute health or which makes the participant likely to be non-compliant with follow-up.","75 Years",{"count":59,"type":21},30,[61,62],"PHASE1","PHASE2","The purpose of this study is to assess the safety and efficacy of RTX001 in patients with end-stage liver disease. This study is the first time RTX001, a macrophage cell therapy engineered to have an anti-inflammatory and anti-fibrotic effect, will be given to humans.",[65,66,67,68,69,70,71,27],"End-stage Liver Disease (ESLD)","Cirrhosis, Liver","Cirrhosis, Decompensated","Liver Diseases","Fibrosis and Cirrhosis of Liver","Decompensated Liver Cirrhosis","Decompensated Cirrhosis",[73,74,75,76,77,70,78,79,80,81,82,83,84,85,86,87,88,27],"Liver cirrhosis","Cirrhotic","Hepatic Cirrhosis","Chronic Liver Disease","Liver Fibrosis","Child-Pugh Score","MELD Score","Liver Function Tests","Hepatic Encephalopathy","End Stage Liver Disease (ESLD)","Variceal Bleeding","Jaundice","Retractable Ascites","Autologous","Cell Therapy","Macrophage","RECRUITING","2026-01-27",{"date":92,"type":40},"2026-01-28",{"date":94,"type":40},"2024-10-15",{"date":96,"type":21},"2028-11-29",{"name":98,"class":99},"Resolution Therapeutics Limited","NETWORK",14,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":108,"targetDuration":110,"studyType":111,"phases":4,"briefSummary":112,"conditions":113,"keywords":117,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":135},"100585837","long-term-follow-up-to-determine-outcome-in-liver-disease-love-study-100585837","NCT06907563","Long-term Follow-up to Determine Outcome in Liver Disease (LOVE Study)","LOVE","Inclusion Criteria:\n\n* Previous Informed consent for cohort studies\n* \\> 18 years of age\n* Diagnosis of SLD (MASLD, MetALD, ALD)\n\nExclusion Criteria:\n\n* No consent for previous cohort studies\n* \\\u003C 18 years of age\n* No Diagnosis of SLD (MASLD, MetALD, ALD)",{"count":109,"type":21},30000,"10 Years","OBSERVATIONAL","The rational to conduct the LOVE study builds on the lack of available data on outcomes in steatotic liver disease in well characterized patients over a time frame of several years. At current limited data on liver-specific and overall outcome in patients with MASLD, MetALD and ALD are available. Liver histology is the only accepted surrogate to reasonably likely predict outcomes in patients with non-cirrhotic liver disease and is currently used in regulatory trials. To overcome the limitations of liver biopsy and use validated non-invasive tests (NITs) to predict outcomes, the LOVE study will be conducted based on existing cohort studies in well pheno- and genotyped patients and will inform on the relevant outcomes based on baseline and ongoing biomarker assessment. The overarching goal is to qualify a NIT for patient identification and preventive measures in the regulatory context.",[27,114,115,116],"MASLD\u002FMASH (Metabolic Dysfunction-Associated Steatotic Liver Disease \u002F Metabolic Dysfunction-Associated Steatohepatitis)","Steatotic Liver Disease of Mixed Origin (MetALD)","ALD - Alcoholic Liver Disease",[118,119,120,121,122,123,124,125],"MASH","SLD","NITs","MASLD","ALD","MetALD","Metabolism","Liver","2025-03-26",{"date":128,"type":40},"2025-04-02",{"date":130,"type":21},"2025-04-15",{"date":132,"type":21},"2035-12-31",{"name":134,"class":47},"Universität des Saarlandes",4]