[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"alcohol-associated-hepatitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:alcohol-associated-hepatitis":134},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,82,112],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100597603","phase-2-integrated-therapies-for-alcohol-use-in-alcohol-associated-liver-disease-itaald-trial-100597603",false,"NCT07060638","Integrated Therapies for Alcohol Use in Alcohol-associated Liver Disease (ITAALD) Trial","ITAALD","Inclusion Criteria\n\n* Age ≥18, \\\u003C70\n* MELD 20-35 on day of randomization\n* Definitive or probable diagnosis as defined by the NIAAA criteria\n* Onset of jaundice (defined as serum total bilirubin \\>3 mg\u002FdL) within the prior 8 weeks\n* Ongoing consumption of \\> 40 gm (for females) and \\> 60 gm (for males) alcohol daily for 6 months or more with less than 8 weeks of abstinence before onset of jaundice\n* AST \\> 50 IU\u002FL,\n* AST: ALT \\> 1.5\n* ALT and AST values \\\u003C 400 IU\u002FL\n* and\u002For histological evidence of AH\\*\n\n  \\*In patients with possible AH or AH with confounding factors such as possible ischemic hepatitis, possible DILI, uncertain history of alcohol use (e.g., patient denies excessive alcohol use), and atypical\u002Fabnormal laboratory tests (e.g., AST \\\u003C 50 IU\u002FL or \\> 400 IU\u002FL, AST\u002FALT ratio \\\u003C 1.5), antinuclear antibody \\> 1:160 or SMA \\> 1:80, a standard of care liver biopsy may be performed during current hospital admission to confirm AH and exclude competing etiologies.\n* Females of childbearing (reproductive) potential must have a negative serum or urine pregnancy test at screening.\n\nExclusion Criteria\n\n* Active listing for liver transplantation before screening\n* MELD score \\\u003C20 or \\> 35\n* Uncontrolled infection (persistent positive blood or other body fluid cultures despite 48 hours of antibiotic therapy)\n* Progressive hemodynamic compromise requiring intravenous pressors\n* Pneumonia as evidenced by clinical and radiological examination\n* Renal failure defined by estimated GFR \\\u003C35 mL\u002Fmin.\n* Clinically active C. diff infection\n* Evidence of other liver diseases (such as autoimmune hepatitis, primary biliary cholangiopathy, primary sclerosing cholangitis, ischemic, sepsis- or drug-induced liver disease)\n* History or presence of cancer (including hepatocellular carcinoma) other than non- melanoma skin cancer\n* Prior exposure to systemic corticosteroid (glucocorticoid) or immunosuppressive therapy for more than 2 days within the previous 30 days\n* Current use of naltrexone or acamprosate.\n* Clinically significant pancreatitis- abdominal pain, elevated lipase (\\> 3 X ULN), and at least edema of pancreas with fat-stranding on CT scan\n* Active gastrointestinal bleeding defined as hematemesis or melena with a decrease in hemoglobin more than 2 g\u002Fdl in 24 hours due to gastrointestinal bleeding, or with a decrease in mean arterial BP to \\\u003C 65 mmHg\n* Significant concomitant medical illnesses (such as uncontrolled congestive heart failure or COPD or progressive multi-organ failure) as determined by the study investigator\n* Uncontrolled mental illness as determined by the study investigator\n* Uncontrolled HBV, HIV, or HCV infection with persistent viremia. However, subjects with controlled (undetectable viral load) HIV and HBV on viral suppressive therapies will be enrolled and subjects with history of HCV will be enrolled if they have evidence of SVR one year prior to enrollment\n* Active illicit opiates, cocaine, ketamine, or methamphetamine use in the last 30 days.\n* Uncontrolled diabetes mellitus with A1c \\> 9\n* Pregnancy or breastfeeding\n* Known allergy or intolerance to therapeutic agents to be tested\n* Unwillingness to stop alcohol use and to undergo AUD treatment\n* Unwillingness to either abstain from sexual intercourse, or if sexually active, use a reliable method of birth control during the study and for at least 30 days after the last dose of the study medication. Examples of acceptable birth control methods include double barrier method such as condom and occlusive cap (diaphragm or cervical cap) with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository; birth control pills, patches, injections, or implants; intrauterine device (IUD); vasectomy and tubal ligation.\n* Participant has any condition or circumstance that adversely affects the participant, could cause noncompliance with treatment or visits, may impact the interpretation of clinical data, could cause bias, or may otherwise contraindicate the participant's participation in the study.","ALL","18 Years","70 Years",{"count":20,"type":21},216,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a multicenter, randomized, double-blinded, placebo-controlled trial focused on the treatment of severe alcohol-associated hepatitis (sAH) and alcohol use disorder (AUD).\n\nThe primary purpose of the study is to determine whether subjects receiving sAH therapy in addition to AUD treatments will have better alcohol and liver-related outcomes at 6 months compared to sAH therapy plus usual care for AUD. Patients assigned to the AUD treatment will receive Acamprosate and counseling whereas those assigned to AUD standard care will receive brief advice and referral to a 12-step program.\n\nThe secondary purpose of the study is to determine if F-652 is safe and effective in treating sAH when compared to prednisone. Subjects will receive F-652 on days 1 and 7 or prednisone for 28 days. Outcomes will be measured by overall survival at 90 days.",[27],"Alcohol-associated Hepatitis",[29],"Severe AH, AUD","RECRUITING","2026-06-26",{"date":33,"type":34},"2026-06-29","ACTUAL",{"date":36,"type":34},"2026-01-27",{"date":38,"type":21},"2029-12",{"name":40,"class":41},"Samer Gawrieh","OTHER",6,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":61,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":4},"100628741","financial-rewards-for-reducing-alcohol-use-in-patients-with-liver-disease-100628741","NCT07465588","Financial Rewards for Reducing Alcohol Use in Patients With Liver Disease","Randomized Evaluation of Incentives FOR Clinical Effectiveness in Liver Recovery (REINFORCE Trial): A PEth-Based Contingency Management Pilot Randomized Controlled Trial for Alcohol Use Disorder in Patients With Alcohol-Associated Liver Disease","REINFORCE","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Diagnosis of alcohol use disorder based on DSM 5 criteria\n* Diagnosis of alcohol associated liver disease or clinically suspected alcohol related liver injury\n* Evidence of recent alcohol use or at risk for alcohol relapse\n* Receiving care in hepatology or liver disease clinic at the participating institution\n* Willingness to undergo serial phosphatidylethanol (PEth) testing using dried blood spot samples\n* Ability to provide informed consent\n* Willingness to participate in the contingency management intervention and follow study procedures\n\nExclusion Criteria:\n\n* Severe cognitive impairment or medical condition that prevents participation in study procedures\n* Active psychosis or severe psychiatric instability that would interfere with participation\n* Current enrollment in another contingency management program targeting alcohol use\n* Medical instability requiring hospitalization at the time of enrollment\n* Inability to communicate in English (if study materials are only available in English)\n* Any condition that, in the opinion of the investigators, would make participation unsafe or interfere with completion of the study",{"count":52,"type":21},90,[54],"NA","This study tests whether providing financial rewards based on a blood test result can help people with alcohol-associated liver disease (ALD) stop or reduce their drinking. The blood test is called phosphatidylethanol (PEth), which can detect alcohol use over the past three to four weeks. The financial reward program is called contingency management (CM).\n\nThe study has two parts. Part 1 involves one-time interviews and surveys with patients and healthcare providers to understand how a PEth-based CM program could best be delivered in a liver disease clinic. Part 2 is a pilot randomized controlled trial (the REINFORCE Trial) in which participants are randomly assigned to one of two groups: (1) a rewards group that receives escalating financial incentives when PEth results show reduced or no alcohol use, or (2) a monitoring group that receives fixed payments regardless of PEth results. Both groups receive PEth testing and continue their usual medical care. The study will assess whether the rewards program improves alcohol abstinence and reduction at 12 and 24 weeks.'",[57,58,59,60],"Alcohol Use Disorder","Alcohol-associated Liver Disease","Liver Cirrhosis, Alcoholic","Alcohol-Associated Hepatitis",[62,63,64,65,66,67,68,69,70,71],"Contingency Management","Phosphatidylethanol","PEth","Dried Blood Spot","Alcohol Biomarker","Alcohol Abstinence","Hepatology","Liver Disease","Financial Incentives","Behavioral Intervention","NOT_YET_RECRUITING","2026-03-10",{"date":75,"type":34},"2026-03-12",{"date":77,"type":21},"2026-08-01",{"date":79,"type":21},"2028-06-30",{"name":81,"class":41},"Massachusetts General Hospital",{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":90,"targetDuration":4,"studyType":22,"phases":92,"briefSummary":94,"conditions":95,"keywords":96,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":111},"100573769","phase-1-safety-and-tolerability-of-ntr-101-in-patients-with-acute-alcohol-associated-hepatitis-100573769","NCT06750588","Safety and Tolerability of NTR-101 in Patients With Acute Alcohol-Associated Hepatitis","Phase 1, Open Label Study to Evaluate Safety and Tolerability of NTR-101 in Patients With Acute Alcohol-Associated Hepatitis","PhoenixAH","Key Inclusion Criteria:\n\n* Diagnostic definition of acute alcohol-associated hepatitis based on well established standard disease markers\n* Able to provide written informed consent (either from patient or patient's legally authorized representative)\n* Male and female patients aged ≥18 years and ≤ 70 years of age\n* BMI ≥ 20 to ≤ 40 kg\u002Fm2\n* Enterococcus faecalis testing\n* Susceptibility to NTR-101\n* Women of child-bearing potential and male patients must agree to use a medically acceptable method of contraception\u002F birth control throughout the study duration.\n\nKey Exclusion Criteria:\n\n* Participants considered at high risk for alcohol withdrawal according to the clinical institute withdrawal assessment (CIWA-Ar) protocol\n* Participants taking systemic corticosteroids for a specified duration\n* Platelet count below specified ranges\n* INR and Serum creatinine levels above specified ranges\n* Active bacterial or viral infections\n* Other or concomitant cause(s) of liver disease as a result of other conditions\n* Co-infection with HIV\n* Positive urine drug screen\n* Any significant systemic or major illness other than liver disease that, in the opinion of the investigator, would preclude the patient from participating in and completing the study or might complicated or exacerbated by the proposed treatments or might confound assessment of investigational product\n* If female, known pregnancy, or has a positive serum pregnancy test, or lactating\u002F breastfeeding",{"count":91,"type":21},12,[93],"PHASE1","The goal of this clinical trial is to learn about the safety and tolerability of NTR-101 in adult participants suffering from acute alcohol-associated hepatitis (AH).\n\nThe drug is intended for use in the treatment of AH where the presence of specific strains of E. faecalis play a contributing role.\n\nThe main questions it aims to answer are:\n\nAre multiple doses of NTR-101 in participants with acute AH safe and well tolerated? What medical problems do participants have when taking NTR-101? Researchers will administer the drug and monitor participants in an inpatient center.\n\nParticipants will:\n\nBe administered multiple ascending dose frequencies of NTR-101 every day for 7 days.\n\nStay in the clinic for 9 days (7 days of treatment) and present to clinic once every week for checkups and tests for 35 days.\n\nKeep a diary of their symptoms until the checkups and tests are completed.",[60],[97,98,99,100],"bacteriophages","alcohol-associated hepatitis","NTR-101","bacteriophage therapy","2025-08-13",{"date":103,"type":34},"2025-08-17",{"date":105,"type":21},"2025-11-05",{"date":107,"type":21},"2026-06",{"name":109,"class":110},"Nterica Bio inc","INDUSTRY",1,{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":22,"phases":122,"briefSummary":123,"conditions":124,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":111},"100560836","phase-2-effect-of-alpha-1-antitrypsin-supplementation-on-alcohol-associated-hepatitis-100560836","NCT06582329","Effect of Alpha-1 Antitrypsin Supplementation on Alcohol-Associated Hepatitis","Effect of Alpha-1 Antitrypsin Supplementation on Alcohol-Associated Hepatitis - A Prospective Pilot Study","EARTH","Inclusion Criteria:\n\n1. Male or female patient ≥18 years of age at time of consent.\n2. Severe AAH (Maddrey's discriminant function score ≥ 32) at screening.\n3. No ACLF or ACLF Grade 1 at screening.\n4. Daily average intake of \\>80 g (men)\u002F\\>60 g (women) ethanol during the past 3 months (patient reported).\n5. Understands and agrees to comply with the study procedures and provides written informed consent as documented by signature.\n6. Outpatient or hospitalized patient not being on the Intensive Care Unit (ICU) at screening.\n\n   Inclusion criterion 7 only applies to women of childbearing potential (WOCBP)\n7. Negative urine pregnancy test, not breastfeeding \\& agreement to use highly-effective means of contraception during the study. Allowed are sexual abstinence, vasectomized partners (˃3 months previously-vasectomy has to be confirmed by two negative semen analyses) or the consistent and correct use of an approved contraceptive method in accordance with the product label, for example: Barrier method (such as condoms, diaphragm, or cervical cap) used in conjunction with spermicide; intrauterine device; prescription hormonal contraceptive taken or administered via oral (pill), transdermal (patch), subdermal, or intramuscular (IM) route Inclusion criterion 8 only applies to male patients\n8. Male patients who are sexually active with female partners of childbearing potential must agree to use a condom with spermicide and to use one other approved method of highly effective contraception from the time of investigational product administration for at least 90 days after the dose of investigational product and must refrain from sperm donation from Screening through at least 90 days following the last dose of investigational product.\n9. Ability to speak and read German to a level which allows fully comprehending the meaning of everything that is said and written.\n\nExclusion Criteria:\n\n1. Uncontrolled Diabetes Mellitus type 1 or 2 (defined by HbA1c \\> 10%).\n2. Corticosteroid use contraindicated.\n3. Viral hepatitis, autoimmune hepatitis, HIV infection, Wilson disease, hemochromatosis, toxic liver injury, Primary Biliary Cholangitis (PBC), Primary Sclerosing Cholangitis (PSC).\n4. Participation in another interventional clinical study within 6 months prior to screening and\u002For during trial participation.\n5. Presence of any active malignancy (other than non-melanoma skin cancer) which required treatment within the past 12 months.\n6. Chronic kidney disease receiving dialysis.\n7. Do Not Attempt Resuscitation (DNAR) order in place.\n8. IgA deficiency (IgA level \\\u003C7mg\u002FdL) or known intolerance to A1AT.\n9. History of liver transplantation or currently listed for liver transplant.",{"count":121,"type":21},16,[24],"The trial is designed as a prospective, single center, open label, randomized controlled pilot study evaluating the effect of A1AT (Alpha 1 Antitrypsin) on inflammation in patients with severe AAH (alcohol-associated hepatitis).\n\nThe objective is to evaluate the safety and the effect of intravenous A1AT on the systemic inflammation in patients with severe AAH. The objectives also include the assessment of A1AT on clinical outcomes including the incidence of adverse events (AEs) and serious adverse events (SAEs) and the cytokine.",[60],"2025-03-05",{"date":127,"type":34},"2025-03-06",{"date":129,"type":21},"2025-04",{"date":131,"type":21},"2026-12",{"name":133,"class":41},"Medical University Innsbruck","Alcohol Associated Hepatitis"]