[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"alcoholic-hepatitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:alcoholic-hepatitis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,46,74,105,126,147,168,200,220,248,271,291],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100350622","alcohol-treatment-outcomes-following-early-vs-standard-liver-transplant-for-sah-100350622",false,"NCT03845205","Alcohol Treatment Outcomes Following Early vs. Standard Liver Transplant for SAH","Alcohol Treatment Outcomes Following Early vs. Standard Liver Transplant for Severe Alcoholic Hepatitis (SAH)","Inclusion Criteria:\n\n* English speaking\n\nExclusion Criteria:\n\n* too medically\u002Fpsychiatrically ill to participate\n* not able to provide informed consent due to cognitive impairment","ALL","18 Years",{"count":19,"type":20},200,"ESTIMATED","INTERVENTIONAL",[23],"NA","Given the severe consequences of alcohol relapse following liver transplantation for alcoholic hepatitis (AH-LT), it is critical to accurately identify alcohol use and implement alcohol interventions early in the post-transplant period to optimize patient outcomes. The proposed randomized clinical trial will examine the implementation and effects of integrated, person- and computer-delivered alcohol treatment compared to standard care on alcohol use (assessed by self-report and biomarker), mood, quality of life and survival following AH-LT. Predictors of 12-month post-transplant alcohol outcomes will be explored to allow future improved tailoring and targeting of these treatments.",[26,27],"Alcohol Use Disorder","Alcoholic Hepatitis",[29,30,31,32],"Alcohol treatment","Liver transplant","Motivational intervention","Cognitive-behavioral therapy","RECRUITING","2026-06-05",{"date":36,"type":37},"2026-06-09","ACTUAL",{"date":39,"type":37},"2020-11-20",{"date":41,"type":20},"2027-06",{"name":43,"class":44},"Johns Hopkins University","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":45},"100589597","phase-3-prolonged-corticosteroid-treatment-or-n-acetylcysteine-for-severe-alcoholic-hepatitis-100589597","NCT06956482","PROlonged Corticosteroid Treatment or N-ACetylcysteine for Severe Alcoholic Hepatitis","PROCORNAC","Inclusion Criteria:\n\n* Patients aged 18-75\n* Alcohol consumption of more than 40g\u002Fday (women) and 50g\u002Fday (men)\n* Recent onset of jaundice (\\\u003C3 months)\n* Biopsy proven alcoholic hepatitis (transjugular liver biopsy)\n* Maddrey's discriminant function ≥ 32, defining severe alcoholic hepatitis\n* MELD score ≥ 17\n* Patients covered with social insurance\n* Patients having provided written informed consent to participate\n\nExclusion Criteria:\n\n* Hepatocellular carcinoma\n* Uncontrolled gastrointestinal bleeding\n* Previous severe allergy or hypersensitivity to N-acetylcysteine (anaphylactic shock, Quincke edema, severe urticaria)\n* Hypersensitivity to any component of the medication\n* MELD score \\\u003C17\n* Type 1 hepatorenal syndrome before the initiation of treatment\n* Severe extrahepatic disease, with life expectancy \\\u003C 6 months\n* Any malignant tumor \\\u003C 2 years (except skin carcinomas)\n* Ongoing viral or parasitic infection\n* Untreated bacterial infection\n* Tuberculosis \\\u003C 5 years\n* Positive blood PCR in patients with positive antibodies against HCV\n* Patient carrying HBV or HIV\n* Treatment with corticosteroids, immunosuppression therapy or budesonide within 6 months before the study","75 Years",{"count":55,"type":20},477,[57],"PHASE3","Only patients suffering from a severe form of alcoholic hepatitis (Maddrey's discriminant function greater than 32) require medical treatment. Oral prednisolone for 28 days is the only treatment which has been proven to improve short-term survival over placebo in patients with severe alcoholic hepatitis. However, prednisolone alone cannot be regarded as an ideal treatment because some patients still have a bad outcome despite being treated with corticosteroids. Response to treatment can be predicted by the Lille score, a simple tool that is calculated after 7 days of prednisolone course. The ideal binary cut-off of the Lille is 0.45, responders having a Lille score \\\u003C 0.45 and non-responders having a Lille score ≥0.45. In terms of treatment management, approximately 30% of patients with severe alcoholic hepatitis do not take benefit from prednisolone and are classified as null responders by a Lille score greater than 0.56. In them, there is a consensus for stopping prednisolone after a 7-day course of treatment (Lille score is calculated after 7 days) while patients with a Lille score \\\u003C0.56 continue treatment for a total of 30 days.\n\nNumerous trials have attempted to test the impact of other strategies in association with prednisolone, but none of them has shown an improvement in survival (primary endpoint) as compared to prednisolone alone. These strategies include for instance pentoxifylline, amoxicillin-clavulanic acid and enteral nutrition.\n\nBecause oxidative stress is a major driver of liver injury during alcohol-related liver disease, antioxidants, especially N-acetylcysteine, have been tested for many years to treat alcoholic hepatitis. N-acetylcysteine alone does not seem to bring a survival benefit over placebo while it may improve outcome when combined to prednisolone.\n\nHistorically in severe alcoholic hepatitis, treatment is only given for one month. However, a significant proportion of patients still disclose impaired hepatic function after treatment has been stopped (e.g. 50% of patients still have a MELD score ≥17 after 60 days in). It is thus tempting to hypothesize that a proportion of patients will recover slowly and may take benefit from a prolonged treatment. Such strategy has been proposed in some old studies with relatively limited sample size but never tested with a rigorous approach.\n\nIn the present study, for the first time in alcoholic hepatitis, we will take into account the recent recommendations of international experts by choosing an innovative primary endpoint that does not only include mortality and evaluate this endpoint at the preferred timepoint of 90 days.\n\nAfter more than 30 years of negative trials in severe alcoholic hepatitis, the present study is aimed to evaluate two important new strategies to decrease both mortality and liver impairment.",[27],[61,62,63,64],"Alcoholic hepatitis","survival, prednisolone","N-acetylcysteine","liver insufficiency","2026-05-27",{"date":67,"type":37},"2026-06-01",{"date":69,"type":37},"2026-05-22",{"date":71,"type":20},"2030-05",{"name":73,"class":44},"University Hospital, Lille",{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":45},"100539755","intra-hepatic-microbiota-in-alcoholic-hepatitis-100539755","NCT06307964","Intra-Hepatic Microbiota in Alcoholic Hepatitis","HepMAH","Inclusion Criteria:\n\n* Patients suffering from alcoholic liver disease and clinical suspicion of alcoholic hepatitis (subacute jaundice, heavy alcohol consumption active or weaned for ≤ 3 months, modified Maddrey score ≥32) and indication for diagnostic transjugular liver biopsy;\n* Non-objection obtained from the patient or trusted person in case of impaired judgment or consciousness before performing liver biopsy;\n* Aged ≥ 18 years at the time of study entry;\n\nExclusion Criteria:\n\n* Patients who were treated with antibiotics or probiotics between the 15th day and 72 hours prior to liver biopsy, with the exception of antibiotics used for the prophylaxis of ascites infection or hepatic encephalopathy\n* Contraindication to transjugular liver biopsy (hepatocellular carcinoma on predicted puncture site)\n* Pregnant, parturient or breast-feeding women\n* Persons deprived of their liberty by judicial or administrative decision\n* Adults under legal protection (guardianship, curators)",{"count":82,"type":20},50,"OBSERVATIONAL","Alcoholic hepatitis (AH) is a serious complication of alcoholic liver disease (ALD). The histological presentation of AH is characterized by neutrophilic lobular inflammation, macrovesicular steatosis, hepatocyte ballooning and necrosis and the presence of Mallory bodies. In cases of severe HA, defined by a modified Maddrey score of 32 or above, mortality at 1 month is estimated at between 10 and 50%. The only treatment to reduce early mortality is corticosteroid therapy. However, only 60% of patients respond to corticosteroids, and no benefit has been demonstrated on late mortality. Identifying new therapeutic targets is therefore a major challenge in this disease.\n\nNumerous pre-clinical studies and human data suggest the involvement of the intestinal microbiota in the pathogenesis of AH. Translocation of viable bacteria and microbial products from the digestive tract to the liver contributes to local and systemic inflammation, hepatocyte death and fibrogenesis. However, the intrahepatic microbial environment has never been characterized in HA.\n\nThe study hypothesis is that the intrahepatic microbiota is modulated by bacterial translocation and is associated with clinical outcomes.\n\nThe aim of this study is to determine the composition of the intrahepatic (obtained from transjugular liver biopsy), blood and fecal microbiota in patients with suspected severe AH from a monocentric prospective cohort in the Hepatology Department at Croix-Rousse Hospital (Lyon). Fifty consecutive patients with clinical suspicion of AH and indication for transjugular liver biopsy will be included. About thirty-five patients are expected in the confirmed AH group, and 15 in the group \"alcoholic liver disease with no AH\", based on data from the literature. The composition of the various microbiota will be determined by sequencing the 16S rRNA gene, and the results will be correlated with clinical data (corticosteroid sensitivity, overall survival, transplant-free survival, MELD score in particular) and histological data.\n\nThis exploratory study will enable to analyze the intra-hepatic microbiota, and to study its link with intra-hepatic inflammation and the clinical course of patients with AH. The data generated by HepMAH will thus help identify potential new therapeutic targets linked to the gut microbiota, and provide a scientific basis for the development of therapeutic interventions targeting the microbiota in HA.",[86,87,27],"Cirrhosis","Alcoholic Liver Disease",[89,90,91,92,93,94,95],"alcoholic hepatis","bacterial translocation","microbiota","16S rRNA","intra-hepatic microbiota","cirrhosis","alcoholic liver disease","2026-02-06",{"date":98,"type":37},"2026-02-10",{"date":100,"type":37},"2024-07-23",{"date":102,"type":20},"2028-07-23",{"name":104,"class":44},"Hospices Civils de Lyon",{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":111,"targetDuration":4,"studyType":21,"phases":113,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":45},"100461906","utility-of-the-use-of-n-acetylcysteine-associated-with-conventional-treatment-in-patients-with-severe-acute-alcoholic-hepatitis-maddrey-32-100461906","NCT05294744","Utility of the Use of N-acetylcysteine Associated With Conventional Treatment in Patients With Severe Acute Alcoholic Hepatitis (Maddrey> 32)","Inclusion Criteria:\n\n* Men and women.\n* Age from 18 to 75 years.\n* Patients with acute alcoholic hepatitis according to AASLD criteria or compatible liver histology.\n* Maddrey score\\> = 32.\n* Acceptance of participation through written informed consent.\n\nExclusion Criteria:\n\n* Any cause of jaundice: acute hepatitis, positive HIV serology, biliary-pancreatic pathology, hemolytic anemia.\n* Allergy or intolerance to N-acetylcysteine and \u002F or corticosteroids.\n* Hepatocarcinoma.\n* Portal cavernomatosis.\n* Portal cavernomatosis.\n* Any disease whose life expectancy is less than 12 months.\n* Patients with nitroglycerin and \u002F or carbamazepine-based treatments.\n* Patients with uncontrolled active infection.\n* Acute kidney disease with creatinine\\> 2.5 mg \u002F dL.\n* Uncontrolled upper gastrointestinal bleeding.\n* Concomitant uncontrolled diseases (HBV, HCV, HIV, TB, DILI, HCC or acute pancreatitis).\n* Multiple organ failure or shock.",{"count":112,"type":20},390,[23],"This study is designed to evaluate the hypothesis that patients with severe acute alcoholic hepatitis have lower morbi-mortality if the patients receive treatment with corticosteroids + NAC, compared to patients that only receive corticosteroids.",[27],"2026-01-08",{"date":118,"type":37},"2026-01-12",{"date":120,"type":37},"2022-10-07",{"date":122,"type":20},"2026-12",{"name":124,"class":125},"Bioaraba Health Research Institute","NETWORK",{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":132,"sex":16,"minAge":133,"maxAge":134,"enrollmentInfo":135,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":145,"locationsCount":45},"100369287","peripheral-blood-mononuclear-cells-response-in-healthy-controls-heavy-drinkers-and-patients-with-alcoholic-hepatitis-100369287","NCT04088370","Peripheral Blood Mononuclear Cells Response In Healthy Controls, Heavy Drinkers, and Patients With Alcoholic Hepatitis","Inclusion of Subjects with Alcoholic Hepatitis (AH):\n\n\\*diagnosis of AH either by imaging, biochemical values or liver biopsy as well as drinking history\n\nInclusion Heavy Drinking Controls:\n\n\\*heavy alcohol drinking will be defined as \\>40 g\u002Fday or \\>280g\u002Fweek on average for women and \\>60 g\u002Fday or \\>420 g\u002Fweek on average for men for a minimum of 6 months \\[6\\] and within the 4 weeks prior to study enrollment.\n\nExclusion Criteria for all groups\n\n* inability or unwillingness to sign informed consent\n* cancer\n* autoimmune disease that in the opinion of the PI will confound study data\n\nControl subjects (drinking and non drinking) must meet the following criteria:\n\n* INR \\\u003C 1.4\n* total bilirubin levels must \\\u003C3\n* no prior history of known alcoholic liver disease\n* absence of hepatosplenomegaly (from physical examination or radiographic imaging) or stigmata of liver disease.",true,"21 Years","65 Years",{"count":136,"type":20},30,"Inflammatory responses in response to alcohol have been identified as contributing to the development of alcoholic hepatitis. The inflammatory response including that to LippoPolySaccharide is known to lead to progression of alcoholic liver disease. In addition to the inflammatory response mitochondrial perturbations exist and redox homeostasis is altered in patients with alcoholic hepatitis. Though this is known there have been very few studies targeting mitochondrial function in Peripheral Blood Mononuclear Cells (PBMCs). We plan to collect 50 milliliters of blood from healthy control patients so that we can compare the data to that of patients with alcoholic hepatitis and those who are heavy drinkers without liver disease. In addition to studying mitochondrial function we will investigate cytokine response, as well as fatty acid metabolism, glucose, and insulin measurements",[27],"2025-11-24",{"date":141,"type":37},"2025-11-25",{"date":143,"type":37},"2019-10-08",{"date":122,"type":20},{"name":146,"class":44},"The Cleveland Clinic",{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":16,"minAge":133,"maxAge":134,"enrollmentInfo":154,"targetDuration":4,"studyType":21,"phases":156,"briefSummary":158,"conditions":159,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":45},"100440682","early-phase-1-ha35-moderate-alcoholic-hepatitis-ah-study-100440682","NCT05018481","HA35 Moderate Alcoholic Hepatitis (AH) Study","Mechanism of HA35 in Patients With Alcoholic Liver Disease","Inclusion Criteria:\n\n• Clinical diagnosis of alcoholic hepatitis defined as:\n\n* Regular consumption of alcohol with an intake of \\>60 g daily or \\>420 g weekly on average for men and \\>40 g daily or \\>280 g weekly on average for women for 6 months or more\n\nAND\n\n* MELD \\\u003C21\n* Serum total bilirubin \\>3 mg\u002FdL\n* AST \\>50 IU\u002FI; AST:ALT ratio \\>1.5; Both AST and ALT \\\u003C400 IU\u002FI\n\nOR Histologic evidence of AH.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women\n* Patients with gastrointestinal bleeding within 2 weeks\n* Active infection (positive blood or ascitic fluid culture)\n* Overt encephalopathy\n* Renal failure and\u002For on dialysis\n* Medications that alter muscle protein metabolism\n* Myopathies\n* Other end-stage organ diseases\n* Malignancy\n* Solid organ or hematopoietic transplantation\n* Active alcohol withdrawal or ongoing participation in a Clinical Institute Withdrawal Assessment (CIWA) protocol\n* History of recent upper gastrointestinal resection within past 6 months\n* Acute or chronic liver disease due to other active causes, in addition to alcoholic liver disease\n* Inability to provide consent\n* Creatinine \\>2mg\u002FdL\n* Platelets \\\u003C60,000k\u002Ful\n* PT\u002FINR \\>1.7\n* Presence of pedal edema\n* Use of anti-platelet\u002Fanticoagulation drugs or medications that interfere with blood clotting",{"count":155,"type":20},54,[157],"EARLY_PHASE1","Eligible participants will be asked to take a placebo\u002Ftreatment capsule for 90 days and participate in two in-person study visits, one at the start of the 90 days and the second at the completion of study supplement administration. Both visits will include a physical exam, clinical labs, body composition measurements, muscle strength tests, questionnaires, and urine and stool collections. Additionally, a sugar cocktail will be consumed to measure gut permeability and a muscle biopsy will be collected. The day after the visits, you will need to return to drop off the 24-hour urine collection.\n\nTwo phone visits will be performed in between the in-person visits at day 30 and 60 where you will be asked a series of questionnaires as well as asked about study supplement compliance.",[27],"2025-11-14",{"date":162,"type":37},"2025-11-17",{"date":164,"type":37},"2022-09-01",{"date":166,"type":20},"2027-10-01",{"name":146,"class":44},{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":174,"eligibilityCriteria":175,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":176,"targetDuration":4,"studyType":21,"phases":178,"briefSummary":180,"conditions":181,"keywords":184,"overallStatus":189,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":4},"100584492","phase-2-a-tango-phase-2-study-100584492","NCT06890039","A-TANGO Phase 2 Study","Phase II, Double-blind, Randomized, Placebo-controlled, Multicentre Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of TAK-242 and (G-CSF) in Subjects With (sAH) and (ACLF)","A-TANGO","Inclusion Criteria:\n\n* Patients accepted for inclusion into the study must meet all of the following criteria:\n\n  1. Male and female subjects ≥18 of age and ≤75 years of age\n  2. Compliance with acceptable contraceptive methods.\n  3. With a diagnosis of severe alcoholic hepatitis that is resistant to steroid therapy as defined by a Lille score of \\>0.45 and\u002For in whom steroids are contraindicated.\n  4. Eligible subjects will have Grade 1-3 ACLF with a maximum of three organ failures using the CLIF-C OF score AND the CLIF-C ACLF-CRP score of \\>35 and \\\u003C60.\n\nExclusion Criteria:\n\n* Patients with any of the following criteria are to be excluded:\n\n  * Refusal to give informed consent\n  * Mechanical ventilation due to respiratory failure and\u002For need for renal replacement therapy and or requiring inotropes for circulatory support with a noradrenaline requirement of \\>0.5ug\u002Fkg\u002Fmin to maintain mean arterial pressure \\> 70mmHg\n  * Subject has received any investigational drug within 30 days of randomization\n  * Subject has any of the following conditions:\n\n    * history of liver transplantation\n    * postoperative decompensation after partial hepatectomy\n    * liver failure without underlying chronic liver injury\n  * Any untreated infections (\\\u003C48h antibiotic therapy) including gram-positive infections, active tuberculosis or coinfection with HIV.\n  * Chronic or pre-existing kidney failure, survival prognosis of \\\u003C6 months due to severe co-morbid conditions that might confound study results or compromise subject safety\n  * Methemoglobinemia, clinically-significant disseminated intravascular coagulation, uncontrolled bleeding, sickle cell anemia\n  * Uncontrolled seizures, Creutzfeldt-Jakob disease, glucose-6-phosphate dehydrogenase deficiency.\n  * Active malignancy, premalignant hematological disorders (e.g., myelodysplastic syndrome, chronic myeloid leukemia) or multiorgan failure (≥ 4 organ failures).\n  * Pregnancy or nursing women\n  * Allergy to eggs",{"count":177,"type":20},78,[179],"PHASE2","The purpose of this research is to know if a new combination of drugs (TAK-242 and G-CSF) in combination with standard therapy for acute-on-chronic liver failure (ACLF) is more effective than standard therapy for ACLF treatment and is safe.\n\nDescription of the population to be studied: ACLF is a syndrome that occurs in patients with chronic liver disease, with or without previously diagnosed cirrhosis, which is characterized by acute hepatic decompensation. Cirrhosis is a chronic disease of the liver marked by degeneration of cells, inflammation, and thickening and scarring (fibrosis) of liver tissue. Hepatic decompensation is a sudden decline in liver function. It is characterized by severe liver damage and complications like jaundice (yellowing of the skin or whites of the eyes), ascites (a condition where excess fluid accumulates in the abdominal cavity and in abdominal organs) and encephalopathy (a group of symptoms that result from damage or dysfunction in the brain, causing a range of cognitive and neurological impairments). It may result in liver failure, one or more organ failures other than liver (renal, brain, coagulation, respiratory, cardiovascular), and is associated with increased mortality within 28-days and up to 3 months from onset. Grade 1 ACLF has a \\>15% risk of mortality at 28 days.\n\nPurpose of the study: The investigational medication, TAK-242, is aimed at stopping an \"over-reaction\" of the immune system (the body's defense system) while G-CSF encourages your liver cells to grow. In patients with severe inflammation of the liver due to alcohol \\[severe alcoholic hepatitis (sAH)\\] and ACLF, this over-reaction may cause the liver and other organs in the body to suddenly stop working (organ failure). The hypothesis of the study is that by blocking this over-reaction and encouraging your liver cells to grow your condition may improve.",[182,27,183],"Acute-On-Chronic Liver Failure","Liver Cirrhosis, Alcoholic",[185,186,187,188],"Novel combinatorial therapy","Improve hepatocyte proliferation","ACLF","Liver disease","NOT_YET_RECRUITING","2025-07-23",{"date":192,"type":37},"2025-07-29",{"date":194,"type":20},"2025-09-01",{"date":196,"type":20},"2026-12-31",{"name":198,"class":199},"Yaqrit Ltd","INDUSTRY",{"id":201,"slug":202,"hasResults":11,"nctId":203,"briefTitle":204,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":206,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":208,"conditions":209,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":45},"100597596","investigating-hepquant-duo-test-as-a-biomarker-in-alcohol-related-liver-disease-100597596","NCT07060547","Investigating HepQuant DuO Test as a Biomarker in Alcohol-related Liver Disease","Inclusion Criteria:\n\n* adult with a clinical diagnosis of liver disease due to alcohol who have acute hepatic decompensation.\n\nadult with a combined clinical diagnosis of alcohol-related liver disease (ALD) and nonalcoholic steatohepatitis (NASH).\n\nExclusion Criteria:\n\n* Clinical diagnosis of liver disease with an etiology other than alcohol liver disease unless it is a combined clinical diagnosis of ALD and NASH.\n* patients with solid organ malignancy.\n* patients with other disease affecting the liver including autoimmune, drug-related liver injury, hemochromatosis or Wilson's disease\n* pregnancy\n* under the age of 18",{"count":207,"type":20},40,"This is a study to measure liver recovery in patients with recent alcohol-associated liver injury by assessing liver function and physiology using HepQuant DuO. The HepQuant DuO Test is a blood-based test that involves a drink of a natural compound, cholate, and 2 blood samples at 20 and 60 minutes. The study team is collecting clinical and laboratory data to better monitor and treat patients who have been affected by alcohol-associated liver disease. The study has 4 visits at an outpatient clinic at 1, 3, 6, and 12 months. At each of these visits, participants will undergo a HepQuant DuO test and other standard tests. In addition, the study team will ask about a participant's alcohol use, symptoms, and quality of life.",[27,210],"Alcohol-related Liver Disease","2025-07-01",{"date":213,"type":37},"2025-07-11",{"date":215,"type":37},"2025-06-10",{"date":217,"type":20},"2032-03",{"name":219,"class":199},"HepQuant, LLC",{"id":221,"slug":222,"hasResults":11,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":226,"eligibilityCriteria":227,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":228,"enrollmentInfo":229,"targetDuration":4,"studyType":21,"phases":231,"briefSummary":232,"conditions":233,"keywords":234,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":247},"100586752","phase-3-short-course-steroids-in-alcohol-associated-hepatitis-100586752","NCT06919458","Short Course Steroids in Alcohol Associated Hepatitis","Seven Day Versus Fourteen-day Corticosteroid in Patients With Severe Alcohol -Associated Hepatitis- A Double Blind Randomized Controlled Trail (STASH II)","STASHII","Inclusion Criteria:\n\n* Patients with AAH aged between 18 and 80 years with a MELD score \\>21 and\u002For mDF \\>32 will be included.\n* Patients with infection at baseline will be included if they have controlled infection defined as afebrile for at least 48 hours, sterile cultures and procalcitonin \\\u003C 1 ng\u002Fml.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years, \\> 80 years\n* Active Infection\n* Persistent acute kidney injury (creatinine \\>1.5 mg\u002Fdl) or chronic kidney disease\n* Recent\u002Fongoing bleed\n* Active peptic ulcer disease\n* Hepatocellular carcinoma, portal vein thrombosis or hepatic venous outflow tract obstruction\n* Patients with concomitant other liver diseases including hepatitis B, C\n* Patients with HIV\n* Uncontrolled diabetes mellitus\n* Patients on pentoxifylline or NAC\n* Patients who are unwilling","80 Years",{"count":230,"type":20},146,[57],"Alcohol-associated hepatitis (AAH) is one of the most severe manifestations of the spectrum of alcohol related liver disease (ARLD), with high morbidity and mortality. Currently, corticosteroids are the standard of care for patients with severe AAH, but no consensus exists on the dosing schedule of steroids. The investigators have recently demonstrated that tapering prednisolone over 4 weeks reduces the risk of infections at day 90. However, the investigators wanted to test whether the reduction in the duration of therapy would provide a similar benefit as tapering the dose of prednisolone. Therefore, the investigators planned to assess the impact of a shorter duration of prednisolone on outcomes, including the incidence of infections, survival and adverse events. One group will receive 7 days of prednisolone followed by a placebo for the next seven days, and the other group will receive 40 mg of prednisolone for 14 days. Prednisolone will be stopped in case of non-response and\u002For adverse events to the drug. All infections will be diagnosed by an ID specialist who is blind to the allocated group.",[27],[235,236,237],"STASH II","corticosteroids","infections","2025-04-15",{"date":240,"type":37},"2025-04-17",{"date":242,"type":37},"2025-04-07",{"date":244,"type":20},"2026-04-08",{"name":246,"class":44},"Asian Institute of Gastroenterology, India",2,{"id":249,"slug":250,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":4,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":255,"targetDuration":4,"studyType":21,"phases":256,"briefSummary":258,"conditions":259,"keywords":260,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":269,"locationsCount":45},"100439756","phase-1-safety-evaluation-of-fecal-microbiota-transplantation-in-severe-alcoholic-hepatitis-100439756","NCT05006430","Safety Evaluation of Fecal Microbiota Transplantation in Severe Alcoholic Hepatitis","Fecal Microbiome Changes Characterization and Safety Evaluation After Oral Administration of Lyophilized Capsules Containing Microbiota Suspension in Severe Alcoholic Hepatitis Patients: Double Blinded, Randomized, Placebo-Controlled Study.","Inclusion Criteria:\n\n1. Any gender; male or female; aged 18- 75 years old.\n2. Severe alcoholic hepatitis defined as 2.1 Onset of jaundice within prior 8 weeks. 2.2 Ongoing alcohol consumption of \\>40 g\u002Fday (3 drinks) in females or \\>60 g\u002Fday (4 drinks) in males for 6 months or more, with less than 60 days of abstinence before the onset of jaundice. 2.3 Aspartate aminotransferase \\>50, Aspartate aminotransferase\u002FAlanine aminotransferase ratio \\> 1.5, BUT both values \\\u003C400 IU\u002FL.\n\n2.4 Serum total bilirubin \\>3.0 mg\u002Fdl. 2.5 MELD score \\>15 and\u002For Maddrey DF score of ≥32.\n\nExclusion Criteria:\n\n1. Non-alcoholic related liver diseases.\n2. Patients with swallowing dysfunction at risk of aspiration.\n3. Patients at risk for or with known anatomic or functional gastrointestinal (GI) obstruction or who have undergone major intra-abdominal surgery in the last year.\n4. Patients who have undergone placement of a portosystemic shunt, infection of which may require prolonged antibiotics.\n5. Patients with any congenital or acquired immunodeficiency (Other than liver disease)\n6. Uncontrolled infections, sepsis, or GI bleeding.\n7. Presence of cancer especially patients with skin cancer who is receiving or may receive systemic chemotherapy or immunotherapy during the study period.\n8. Underlying disease that might be exacerbated by proposed treatments (e.g. HCV, HBV, HIV, TB).\n9. Serum creatinine \\>2.5 mg\u002Fdl at presentation.\n10. Pregnant and breastfeeding patients.\n11. Active use drug addiction.\n12. PI thinks their participation would pose a health risk e.g. patients with very severe AH with MELD score \\>30 or Maddrey DF \\> 60 or patient will be getting liver transplantation imminently.\n13. Any other major illness\u002F condition that in the investigators judgment, will substantially increase the risk to the participant.",{"count":82,"type":20},[257,179],"PHASE1","This is a single center, randomized, parallel assignment, and double-blind placebo-controlled pilot study to characterize the intestinal microbiome in patients with severe Alcoholic Hepatitis (SAH) and evaluate the safety and the trends in improvement of diversity of intestinal microbiome following administration of lyophilized capsules containing microbiota suspension from well screened health donors. The study aims to enroll 50 patients with SAH who will be randomly assigned in 1:1 where 25 patients will be assigned to receive orally administered lyophilized PRIM-DJ2727 and Standard of Care (SOC) and the other 25 patients will be assigned to receive placebo and SOC for 4 weeks.",[27],[261],"Severe alcoholic hepatitis","2025-01-21",{"date":264,"type":37},"2025-01-23",{"date":266,"type":37},"2023-01-21",{"date":268,"type":20},"2025-06-30",{"name":270,"class":44},"Prasun Kumar Jalal",{"id":272,"slug":273,"hasResults":11,"nctId":274,"briefTitle":275,"officialTitle":275,"acronym":4,"eligibilityCriteria":276,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":277,"enrollmentInfo":278,"targetDuration":4,"studyType":21,"phases":280,"briefSummary":281,"conditions":282,"keywords":4,"overallStatus":189,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":45},"100576747","randomized-controlled-trial-of-mycophenolate-mofetil-versus-steroid-therapy-in-alcoholic-hepatitis-100576747","NCT06789315","Randomized Controlled Trial of Mycophenolate Mofetil Versus Steroid Therapy in Alcoholic Hepatitis","Inclusion Criteria:\n\n1. Adults aged 18-70 years.\n2. Diagnosis of Alcoholic hepatitis based on NIAAA criteria\n3. MELD 20-35\n4. Willing to follow up\n\nExclusion Criteria:\n\n1. Patients with hepatic\u002F extra hepatic malignancies\n2. Patients with contraindications to steroids\n3. Patients who are critically ill and are admitted to the ICU\n4. Patient who have severe extra hepatic organ failure\n5. Patients who are HBsAg +, HIV+\n6. If female of childbearing potential: known pregnancy, or unwilling to practice anticontraceptive measures\n7. Patients who are on current treatment with prednisone and\u002For immunosuppressive me.","70 Years",{"count":279,"type":20},60,[23],"Patients with acute alcoholic hepatitis will be identified based on national institute on alcohol abuse and alcoholism (NIAAA) will be identified, MELD score will be calculated, patents with MELD score between 20-35 will be randomized to two groups. Group A (intervention arm) will be receiving Mycofenolate mofetil at a dose of 750 mg twice daily and group B will be receiving steroid as per existing guidelines in a dose of 40 mg per day. Both the groups will be followed up for 90 days with assessment done at 4th, 7th and 28th day. Any significant event in addition will also be noted. Patients in group A will be also be monitored for development of complications like cytopenia due to Mycofenolate mofetil and infections will be monitored in both groups. Steroids will be stopped in the non-responders in group B based on Lille score at 4th and 7th day. The outcome variables of interest and to be measured are survival at 28 days and 90 days, clinical outcomes, including hospitalization and liver related outcomes.",[27],"2025-01-17",{"date":264,"type":37},{"date":286,"type":20},"2025-01-20",{"date":288,"type":20},"2026-01-31",{"name":290,"class":44},"Institute of Liver and Biliary Sciences, India",{"id":292,"slug":293,"hasResults":11,"nctId":294,"briefTitle":295,"officialTitle":296,"acronym":4,"eligibilityCriteria":297,"healthyVolunteers":11,"sex":16,"minAge":133,"maxAge":4,"enrollmentInfo":298,"targetDuration":4,"studyType":21,"phases":300,"briefSummary":301,"conditions":302,"keywords":304,"overallStatus":189,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":4},"100539721","phase-2-mrg-001-in-patients-with-alcoholic-hepatitis-100539721","NCT06307522","MRG-001 in Patients With Alcoholic Hepatitis","An Open-Label, Dose-Escalation Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of MRG-001 in Patients With Alcoholic Hepatitis","Inclusion Criteria:\n\n1. Informed Consent: Able to provide written informed consent, either personally or through a legally acceptable representative.\n2. Male or female patients 21 years of age or older.\n3. Onset of jaundice within the prior 8 weeks.\n4. Alcohol Consumption: Average daily consumption of more than 40 grams for females or more than 60 grams for males of alcohol for 6 months or longer, with less than 8 weeks of abstinence before the onset of jaundice.\n5. Diagnostic Criteria for AH: AH may be diagnosed based on typical serum chemistry or liver biopsy during the current episode of AH, including:\n\n   * Serum bilirubin \\> 3 mg\u002FdL\n   * AST between 50 and 400 IU\u002FL\n   * ALT \\\u003C 400 IU\u002FL\n   * AST\u002FALT ratio \\> 1.5\n6. Maddrey Discriminant Function (MDF): MDF ≥ 32, assuming a control prothrombin time of 12 seconds.\n7. Model for End-stage Liver Disease (MELD) Score: MELD score between 21 and 30.\n8. Liver Biopsy (Optional): Liver biopsy is not required but may be used to confirm the diagnosis of AH at the Investigator's discretion. If used, the biopsy must have occurred during the current episode.\n9. Contraception for Women: Women of childbearing potential must use appropriate birth control throughout the study duration. Contraception for Men: Male patients must agree to use a medically acceptable method of contraception or birth control throughout the study duration.\n\nExclusion Criteria:\n\n1. Informed Consent: Inability to provide written informed consent, either personally or through a legally acceptable representative.\n2. Participation in Other Clinical Trials: Participation in another interventional clinical trial (drug or device) within 30 days of screening and at any time during the study.\n3. Concomitant Liver Diseases: Presence of other concomitant causes of liver disease, such as viral hepatitis, autoimmune liver disease, metabolic liver disease, or vascular liver disease.\n4. Liver Biopsy Incompatibility: Liver biopsy findings, if conducted, not compatible with alcoholic hepatitis (AH).\n5. Absence of Active Infection: No evidence of active infection as determined by the investigator, with specific criteria outlined for diagnosing and treating infections.\n6. Uncontrolled Gastrointestinal Bleeding: Presence of uncontrolled gastrointestinal bleeding.\n7. History of pre-admission refractory ascites, as defined by the frequency of paracenteses despite diuretic therapy.\n8. Significant pre-existing organ dysfunction in various systems, including lung, heart, kidney, hematologic, neurological, and spleen-related conditions.\n\n   1. Lung: Receiving supplemental home oxygen therapy at baseline for pre-existing medical condition (other than COVID-19), as documented in medical record.\n   2. Heart: Pre-existing congestive heart failure defined as an ejection fraction \\\u003C20% as documented in the medical record. Clinically significant ventricular arrhythmias (ventricular tachycardia, ventricular fibrillation), unstable angina, myocardial infarction (past 3 months), heart and coronary vessel surgery (past 3 months), significant valvular heart disease, uncontrolled arterial hypertension with systolic blood pressure \\>180 mm Hg and diastolic blood pressure \\>110 mm Hg.\n   3. Renal: End-stage renal disease requiring renal replacement therapy or creatintine clearance \\\u003C30 mL\u002Fmin.\n   4. Hematologic: Baseline platelet count \\\u003C30,000\u002Fmm3 or hemoglobin levels \\\u003C6.0 g\u002FdL.\n   5. Neurological: Stage ≥3 hepatic encephalopathy by West Haven criteria.\n   6. History of splenectomy or splenomegaly (spleen weighing \\> 750 g).\n9. Presence of any active malignancy or malignancy diagnosed within the last five years, excluding curable skin cancer.\n10. Patients requiring the use of vasopressors or inotropic support, excluding stabilized conditions within the first 7 days of hospital admission.\n11. Presence of co-infection with human immunodeficiency virus (HIV) or active tuberculosis on chest X-ray at study entry.\n12. History of organ or bone marrow transplantation, excluding corneal transplant, or recent chronic use of immunosuppressive drugs.\n13. Positive urine drug screen for specific substances, excluding THC and prescription medications.\n14. Hypersensitivity to either of the components of MRG-001.\n15. If female, known pregnancy, positive serum pregnancy test, or lactating\u002Fbreastfeeding.\n16. Underlying diseases that might be complicated or exacerbated by proposed treatments or confound assessment of study drug, as determined by the site investigator.",{"count":299,"type":20},32,[179],"The goal of this study is to test MRG-001 (an experimental medication). The purpose of this trial is to assess the dose related safety, Pharmacokinetics, and Pharmacodynamics of MRG-001 in patients with severe alcoholic hepatitis (AH).",[27,303],"Acute Alcoholic Hepatitis",[305,306,307,27,308,309,310],"MRG-001","Stem Cells","Immunomodulation","Hepatitis, Alcoholic","Infection","Liver Diseases, Alcoholic","2024-03-05",{"date":313,"type":37},"2024-03-13",{"date":315,"type":20},"2024-09-01",{"date":317,"type":20},"2026-12-01",{"name":319,"class":199},"MedRegen LLC"]