[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"liver-diseases-alcoholic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:liver-diseases-alcoholic":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,78,109],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100563248","phase-2-a-study-to-investigate-the-safety-and-efficacy-of-gsk4532990-compared-with-placebo-in-adult-participants-aged-18-to-70-years-with-alcohol-related-liver-disease-100563248",false,"NCT06613698","A Study to Investigate the Safety and Efficacy of GSK4532990 Compared With Placebo in Adult Participants Aged 18 to 70 Years With Alcohol-related Liver Disease","A Dose-Finding, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of GSK4532990 for Steatohepatitis in Adults With Alcohol-related Liver Disease (ALD)","STARLIGHT","Inclusion Criteria:\n\n* Capable of giving signed informed consent prior to the performance of any study-specific procedures.\n* Able and willing to comply with all study assessments and adhere to the protocol schedule of activities.\n* In the opinion of the investigator, there is a history of alcohol consumption compatible with either ALD or Met ALD.\n* A female participant is eligible to participate after meeting additional pre-defined criteria.\n* Participants must meet predefined stable use requirements of concomitant medications based on study criteria.\n* Participant has advanced chronic liver disease\n\nExclusion Criteria:\n\n* Meeting any definition of organ system failure as defined by the North American Consortium for Study of End-stage Liver Disease (NACSELD)\n* Exceeding pre-defined biochemical parameters for Alanine Aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline Phosphatase (ALP), Platelets, International normalised ratio (INR), Albumin, estimated glomerular filtration rate (eGFR), Urine albumin-creatinine ratio (UACR) or Glycosylated Hemoglobin (HbA1c). Other primary causes of liver disease based on study criteria.\n* Current malignancy (except for basal cell carcinoma or uterine carcinoma-in-situ) at screening. Participants under evaluation for possible malignancy at screening are not eligible.\n* Prior organ transplant or current listing or active consideration for organ transplant during the screening period (except for corneal transplants).\n* Chronic or acute, including partial, known portal vein thrombosis.\n* Prior transjugular intrahepatic portosystemic shunt (TIPSS) insertion.\n* Any acute cardiovascular event including myocardial infarction, unstable angina, symptomatic heart failure, or cerebrovascular accident in the 6 months prior to screening.\n* Poorly controlled hypertension\n* Clinical suspicion of rhabdomyolysis during the screening period\n* Clinical suspicion of a bleeding episode during the screening period related to portal hypertension and\u002For low blood fibrinogen level.\n* Body Mass Index (BMI) \\>35 kg\u002Fm2 at screening\n* Any liver-related clinical event that started (onset) \\\u003C8 weeks prior to Baseline (D1).","ALL","18 Years","70 Years",{"count":21,"type":22},393,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The goal of this study is to assess the safety and efficacy of GSK4532990 in participants with alcohol-related liver disease.",[28],"Liver Diseases, Alcoholic",[30,31,32],"GSK4532990","Alcohol-related liver disease","Steatohepatitis","RECRUITING","2026-03-27",{"date":36,"type":37},"2026-04-01","ACTUAL",{"date":39,"type":37},"2024-09-27",{"date":41,"type":22},"2028-03-07",{"name":43,"class":44},"GlaxoSmithKline","INDUSTRY",131,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100623666","personalized-transcranial-magnetic-stimulation-tms-for-metabolic-dysfunction-and-alcohol-related-liver-disease-100623666","NCT07399600","Personalized Transcranial Magnetic Stimulation (TMS) for Metabolic Dysfunction and Alcohol-Related Liver Disease","Personalized Transcranial Magnetic Stimulation for Metabolic Dysfunction and Alcohol-Related Liver Disease (MetALD): A Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial","P-TMS MetALD","Inclusion Criteria:\n\n* Participants are able to understand the study protocol, requirements, and restrictions, are fully informed of potential adverse events, are willing to comply with follow-up visits, and voluntarily sign the informed consent form before enrollment.\n* Meet the diagnostic criteria for MASLD according to the Guidelines for the Prevention and Treatment of Metabolic (Non-Alcoholic) Fatty Liver Disease (2024 Edition), and fulfill the European definition of MetALD with moderate alcohol consumption (20-50 g\u002Fday for women; 30-60 g\u002Fday for men).\n* Age between 18 and 65 years.\n* Body mass index (BMI) \\> 24 kg\u002Fm².\n* No history of alcohol abuse.\n\nExclusion Criteria:\n\n* Contraindications to magnetic resonance imaging (MRI) or transcranial magnetic stimulation (TMS).\n* Mild cognitive impairment, defined as Montreal Cognitive Assessment (MoCA) score \\\u003C 25.\n* Severe comorbid somatic diseases or neurological disorders.\n* History of psychiatric disorders, or current use of antipsychotic medications.\n* Pregnant or breastfeeding women, or those planning pregnancy.\n* Previous TMS treatment within the last 3 months.","65 Years",{"count":56,"type":22},105,[58],"NA","The goal of this clinical trial is to learn if repetitive Transcranial Magnetic Stimulation (rTMS), a non-invasive brain stimulation technique, works to treat Metabolic dysfunction-associated and alcohol-associated liver disease (MetALD). The main questions it aims to answer are:\n\n* Can rTMS effectively treat MetALD?\n* Is an individualized, precision-targeted rTMS approach more effective than the standard rTMS method?\n* What changes in brain activity are associated with the treatment?\n\nResearchers will compare three different types of stimulation:\n\n* Group A: Individualized rTMS targeting a deep brain reward area (the Nucleus Accumbens) based on each participant's brain scan (fMRI).\n* Group B: Standard rTMS applied using the traditional \"5 cm\" rule for positioning.\n* Group C: Sham (placebo) rTMS, which mimics the procedure but delivers no significant magnetic stimulation.\n\nParticipants will:\n\n* Be randomly assigned to one of the three groups (A, B, or C).\n* Undergo an MRI brain scan before starting treatment.\n* Receive a total of 20 rTMS sessions, completing at least 4 sessions per week.\n* Have additional MRI scans and clinical assessments halfway through and immediately after the treatment course.\n* Attend follow-up visits at 1, 3, and 6 months after treatment completion to assess long-term effects.",[28,61,62],"Fatty Liver","Metabolic Syndrome",[28,61,62,64,65],"Transcranial Magnetic Stimulation","Randomized Controlled Trial","NOT_YET_RECRUITING","2026-02-03",{"date":69,"type":37},"2026-02-10",{"date":71,"type":22},"2026-02-01",{"date":73,"type":22},"2027-12-31",{"name":75,"class":76},"The Affiliated Hospital of Hangzhou Normal University","OTHER",1,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":23,"phases":87,"briefSummary":88,"conditions":89,"keywords":94,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":77},"100554029","alcohol-misuse-treatment-to-patients-newly-diagnosed-with-alcohol-related-liver-disease-a-randomized-controlled-trial-100554029","NCT06493773","Alcohol Misuse Treatment to Patients Newly Diagnosed With Alcohol-related Liver Disease: a Randomized Controlled Trial","Alcohol Misuse Treatment Delivered in the Hepatology Clinic to Patients Newly Diagnosed With Alcohol-related Liver Disease: a Randomized Controlled Trial","Inclusion criteria\n\n* Age \\> 18 years\n* Newly diagnosed alcohol-related liver disease, defined as within six months from baseline visit.\n* A liver stiffness above 8.0 kPa with 10 successful measurements and an interquartile range of less than 30% as assessed with transient elastography.\n* Excessive alcohol consumption defined as \\>7 units\u002Fweek for women and \\>14 units\u002Fweek for men within the previous year.\n* The patient is able to understand the purpose of the study and give informed oral and written consent to participate.\n\nExclusion criteria\n\n* Not enough proficiency in Danish to participate in interviews and questionnaires.\n* Pregnancy\n* Ongoing specialized AUD treatment. Self-help groups and AUD counselling at general practitioners are not counting as specialized AUD treatment in this study.",{"count":86,"type":22},221,[58],"To evaluate the efficacy of systematically offering newly diagnosed ALD patients to AUD treatment, in the hepatology clinic, on alcohol abstinence after 6 months. The investigators will conduct a randomized controlled superiority trial with parallel group design, hypothesis blinding and blinded outcome assessment comparing A) a offer to specialized AUD treatment (intervention) and B) standard care (control). Existing observational cohort ALD members will contribute to the control group in addition to the randomized controls. The primary outcome is abstinence throughout the last 30 days assessed 6 months after randomization.",[28,90,91,92,93],"Alcohol Use Disorder","Treatment Adherence","Alcoholism","Liver Disease; Alcohol-Related",[95,96,97,98,99],"Alcoholic liver disease","Alcohol use disorder","Alcohol treatment","randomized clinical trial","hepatology clinic","2025-11-14",{"date":102,"type":37},"2025-11-18",{"date":104,"type":22},"2025-11-15",{"date":106,"type":22},"2029-04-01",{"name":108,"class":76},"Zealand University Hospital",{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":17,"minAge":116,"maxAge":117,"enrollmentInfo":118,"targetDuration":4,"studyType":23,"phases":120,"briefSummary":121,"conditions":122,"keywords":124,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":77},"100309481","screening-at-risk-populations-for-hepatic-fibrosis-with-non-invasive-markers-100309481","NCT03308916","Screening At-risk Populations for Hepatic Fibrosis With Non-invasive Markers","SIPHON","INCLUSION CRITERIA\n\nPatients are eligible for screening if the following inclusion criteria are fulfilled:\n\n* Age 30-75 years (except the general population, which should be aged 40-75)\n* Informed consent to study investigations\n* Ability to read and write Danish AND (only at-risk patients)\n* Prior or current alcohol overuse, defined as an average intake of ≥24 grams\u002Fday (14 units\u002Fweek) for women and ≥36 grams\u002Fday (21 units\u002Fweek) for men, for at least 5 years; OR\n* Presence of the metabolic syndrome defined by central obesity plus any two of the following four metabolic risk factors: (a) raised triglycerides, (b) reduced HDL cholesterol, (c) raised blood pressure and (d) raised fasting plasma glucose;\\[38\\] OR\n* Type 2 diabetes mellitus defined by either fasting plasma glucose ≥7 mmol\u002FL, HbA1c ≥48 mmol\u002Fmol, a random plasma glucose ≥11.1 mmol\u002FL in the presence of classic diabetes or an oral glucose tolerance test with fasting plasma glucose ≥7.0 mmol\u002FL and\u002For 2 hour plasma glucose ≥11.1 mmol\u002FL.\n\nEXCLUSION CRITERIA\n\nWe will exclude patients from screening in case of:\n\n* Evidence of decompensated liver disease, defined by clinically obvious ascites, overt hepatic encephalopathy, jaundice or large esophageal varices with\u002Fwithout variceal bleeding.\n* Known concurrent liver disease other than ALD and NAFLD.\n* Cancer or other debilitating disease with an expected survival of less than 12 months.\n* Inability to comply with the study protocol.\n\nIn screened patients with liver stiffness ≥8 kPa we will abstain from a liver biopsy in case of:\n\n* Contraindications for a percutaneous liver biopsy\n* Severe alcoholic hepatitis or other hepatic inflammation evidenced by transaminase elevation of more than three times the upper limit of normal.\n* Hepatic congestion or bile duct dilation evidenced by ultrasound.\n* Decrease of TE below 6.0 kPa from screening to time of planned liver biopsy.","30 Years","75 Years",{"count":119,"type":22},6500,[58],"Prospective screening study at Odense University Hospital to assess the effect of transient elastography and other serum and imaging markers of liver fibrosis to detect advanced fibrosis (Kleiner Fibrosis score F3-F4) in patients at risk of non-alcoholic fatty liver disease, alcoholic fatty liver disease, with a control group of participants recruited from the general population.",[28,123],"Fibrosis",[125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,146],"elastography","screening","non-invasive markers","microbiome","gut-liver-axis","cost-benefit","fibroscan","aixplorer","ultrasound elastography","liver fibrosis","alcoholic liver disease","advanced fibrosis","enhanced liver fibrosis test","direct liver fibrosis markers","ELF","cytokeratin-18","neoepitopes","collagen","NAFLD","ALD","metabolomics","non-alcoholic fatty liver disease","2022-08-29",{"date":149,"type":37},"2022-09-01",{"date":151,"type":37},"2017-10-06",{"date":153,"type":22},"2035-10-30",{"name":155,"class":76},"Maja Thiele"]