[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cirrhosis-liver\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cirrhosis-liver":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,57,0,25,[9,46,82,115,135,165,188,212,238,278,299,315,339,364,395,419,443,491,519,543,565,594,615,632,658],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100375766","phase-2-erlotinib-for-hepatocellular-carcinoma-chemoprevention-100375766",false,"NCT04172779","Erlotinib for Hepatocellular Carcinoma Chemoprevention","Phase II Clinical Trial of Low-dose Erlotinib for Hepatocellular Carcinoma Chemoprevention","ECHO-B","Inclusion Criteria:\n\n* Adults (≥ 18 years-old)\n* Clinically and\u002For histologically diagnosed advanced liver fibrosis or cirrhosis\n* No active hepatic decompensation\n* No prior history of HCC\n* FIB-4 index \\> 3.25\n* PLSec score ≥ 3\n* Adequate hematologic, hepatic, and renal function, Karnofsky performance status score ≥70\n* Both sexes and all racial\u002Fethnic groups will be considered\n\nExclusion Criteria:\n\n* Prior treatment with epidermal growth factor receptor (EGFR) inhibitors\n* Uncontrolled intercurrent, use of CYP3A4 modulators\n* Erlotinib treatment \\\u003C4 weeks or \\\u003C80% of planned regimen at the end of week 4\n* HCC development during the study","ALL","18 Years",{"count":21,"type":22},60,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This phase II randomized placebo-controlled trial studies low-dose erlotinib treatment to assess its efficacy and safety to prevent development of hepatocellular carcinoma in patients with advanced liver fibrosis or cirrhosis.",[28,29],"Cirrhosis, Liver","Advanced Liver Fibrosis",[31,32],"hepatocellular carcinoma","chemoprevention","NOT_YET_RECRUITING","2026-06-20",{"date":36,"type":37},"2026-06-24","ACTUAL",{"date":39,"type":22},"2026-12",{"date":41,"type":22},"2030-08",{"name":43,"class":44},"University of Texas Southwestern Medical Center","OTHER",1,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":58,"conditions":59,"keywords":67,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":81},"100503205","phase-2-liver-cirrhosis-network-rosuvastatin-efficacy-and-safety-for-cirrhosis-in-the-united-states-100503205","NCT05832229","Liver Cirrhosis Network Rosuvastatin Efficacy and Safety for Cirrhosis in the United States","Liver Cirrhosis Network (LCN) Rosuvastatin Efficacy and Safety for Cirrhosis in the United States (RESCU): A Double-Blind Randomized, Placebo-Controlled Phase 2 Study","LCN RESCU","Inclusion Criteria:\n\n1. Age 18-75 years\n2. Cirrhosis due to nonalcoholic steatohepatitis, alcohol-associated liver disease, or chronic viral hepatitis (treated hepatitis B virus or hepatitis C virus)\n3. Clinical diagnosis of cirrhosis as defined investigator confirmation and the following:\n\n   1. At least one liver biopsy within 5 years prior to consent showing either: Metavir stage 4 fibrosis; Ishak Stage 5-6 fibrosis, OR\n   2. At least 2 of the following:\n\n   i. Evidence on imaging: Nodular liver with either splenomegaly or recanalized umbilical vein within the past 48 weeks ii. Liver stiffness: vibration-controlled transient elastography within 48 weeks prior to consent or during Screening ≥15 kilopascal or magnetic resonance elastography within 48 weeks prior to consent or during Screening ≥5 kilopascal iii. Evidence of varices demonstrated on imaging or endoscopy within 3 years prior to consent or during Screening iv. Either: Fibrosis-4\\>2.67 or platelets \\<150\u002FmL within 6 months prior to consent or during Screening\n4. Two measures of vibration-controlled transient elastography: one at screening and one at the randomization study visit, meeting the following criteria:\n\n   1. The first measure must be ≥ 15 kilopascal.\n   2. The two measures must be at least 2 hours apart and no more than 60 days apart from one another.\n   3. The mean of two measurements must be ≥ 15 kilopascal.\n   4. Additionally, both screening and open-label dispense liver stiffness measures must be ≤50 kPa\n5. Compensated defined by:\n\n   1. Absence of ascites\u002Fhydrothorax, hepatic encephalopathy or variceal bleeding currently or in the last 48 weeks, as determined clinically by investigator.\n   2. If prior history of decompensation, must be without current symptoms of decompensation and no longer requiring treatment of complications for the last 48 weeks, including the use of diuretics for the treatment of ascites, and\u002For rifaximin or lactulose for the treatment of hepatic encephalopathy. Use of non-selective beta blockers will be allowed.\n   3. Child-Pugh score \\<8\n6. Provision of written informed consent.\n\nExclusion Criteria:\n\n1. Currently on a statin or any statin exposure within 24 weeks prior to consent.\n2. Known indication for statin therapy, defined as:\n\n   1. Prior peripheral vascular, cardiovascular or cerebrovascular event for which statins are indicated for secondary prevention, OR\n   2. Documented familial hypercholesterolemia, heterozygous familial hypercholesterolemia, OR\n   3. Fasting LDL-C ≥ 190 mg\u002FdL\n3. Myocardial infarction, Unstable angina, transient ischemic events, or stroke within 24 weeks of screening.\n4. Alcohol Use Disorder Identification Test (AUDIT) total score of ≥8 at screening.\n5. Patients with limitations in attending study visits.\n6. Prisoners.\n7. Known prior or current hepatocellular carcinoma (HCC) or cholangiocarcinoma.\n8. Known transjugular intrahepatic portosystemic shunt (TIPS), balloon retrograde transvenous obliteration (BRTO) or porto-systemic shunt surgery regardless of time of occurrence.\n9. Current (in past 24 weeks prior to consenting) use of medications known to cause hepatic fibrogenesis or confound endpoint assessment, defined as:\n\n   1. amiodarone\n   2. methotrexate\n   3. warfarin\n10. Current (in past 24 weeks prior to consenting) use of medications which may increase risk for rosuvastatin-related myositis or DILI, defined as:\n\n    1. fenofibrate\n    2. erythromycin\n    3. gemfibrozil\n    4. niacin (500 mg or more)\n    5. HIV protease inhibitors (darunivar, indinavir, nelfinavir, amprenavir) in patients of East Asian descent\n    6. colchicine\n    7. cyclosporin\n    8. Additional medications that will be excluded:\n\n    atazanavir\u002Fritonavir capmatinib darolutamide dasabuvir\u002Fombitasvir\u002Fparitaprevir\u002Fritonavir ledipasvir\u002Fsofosbuvir elbasvir\u002Fgrazoprevir erythromycin glecaprevir\u002Fpibrentasvir lopinavir\u002Fritonavir regorafenib ritonavir, in any combination simeprevir sofbuvir\u002Fvelpatasvir\u002Fvoxilaprevir sofosbuvir\u002Fvelpatasvir tafamidis teriflunomide\n\n    \\*If exposure was for 7 or less days for one of these medications can consider enrollment after 28 days from final dose.\n11. Presence of portal or hepatic vein thrombosis\n12. Diagnosis of untreated hypothyroidism or on unstable treatment regimen for hypothyroidism\n13. Receiving an elemental diet or parenteral nutrition\n14. Chronic pancreatitis or pancreatic insufficiency\n15. Etiology of cirrhosis other than ALD, NAFLD, or viral hepatitis (excluded diagnoses include cryptogenic immune-mediated such as AIH, PSC and PBC, cardiac cirrhosis or Fontan-associated liver disease, A1AT, Wilson's disease, etc.)\n16. Conditions which may confound study outcome:\n\n    1. Unstable or active inflammatory bowel disease\n    2. Active infection\n    3. Any malignant disease (other than squamous or basal cell carcinoma of the skin) within previous 3 years\n    4. Prior solid organ or hematopoietic cell transplant\n    5. Bariatric surgery in the last 24 weeks prior to consent or planned bariatric surgery within the next 96 weeks\n    6. Current liver-unrelated end-stage organ failures such as end-stage renal disease on dialysis, stage 3-4 congestive heart failure (CHF), current chronic obstructive pulmonary disease (COPD) on home oxygen.\n17. Known current medical or psychiatric conditions which, in the opinion of the investigator, would make the participant unsuitable for the study for safety reasons or interfere with or prevent adherence to the protocol.\n18. The following laboratory abnormalities within 90 days of screening:\n\n    1. Hemoglobin \\\u003C10 g\u002FdL\n    2. Albumin \\\u003C3.0 g\u002FdL\n    3. Prolonged international normalized ratio (INR) \\>1.5\n    4. Total bilirubin ≥ 2.0 mg\u002Fdl (unless due to Gilbert's syndrome or hemolysis as denoted by normal direct bilirubin fraction)\n    5. Direct bilirubin ≥ 0.9\n    6. Uncontrolled diabetes (HbA1c ≥ 9.5%) within past 90 days.\n19. Kidney function abnormalities including:\n\n    1. Dialysis\n    2. Baseline eGFR \\\u003C 30 cc\u002Fmin with CKD-Epi equation\n    3. Known nephrotic proteinuria, defined as 3g or greater of protein in 24-hour urine collection\n20. Recent (within 48 weeks) or present hepatic decompensation with ascites\u002Fhydrothorax, hepatic encephalopathy or variceal bleeding\n21. Untreated chronic hepatitis B or C infection\n\n    1. HCV eligible for enrollment if HCV RNA negative at baseline or documentation of prior SVR12\n    2. HBV eligible if an HBV DNA \\\u003C100 IU\u002FmL within the last 48 weeks and on treatment\n22. Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 200 U\u002FL, or alkaline phosphatase (ALP) ≥ 300 within the past 24 weeks.\n23. Documented history of intolerance to statins\n24. Serious comorbid medical disease which in the investigator's opinion renders a life-expectancy less than 96 weeks\n25. Active illicit substance use (other than THC), including inhaled or injected drugs, in the 24 weeks prior to screening\n26. Pregnancy, planned pregnancy or breastfeeding\n27. Current participation in active medication treatment trials (within 24 weeks prior to randomization) or planned participation in active medication treatment trials simultaneous to participation in present trial.\n28. Significant existing muscle pain or tenderness or prior history of myasthenia gravis as determined by a site physician.\n29. Failure or inability to provide informed consent.","75 Years",{"count":56,"type":22},256,[25],"This is a double-blind, phase 2 study to evaluate safety and efficacy of rosuvastatin in comparison to placebo after 2 years in patients with compensated cirrhosis.",[60,28,61,62,63,64,65,66],"Cirrhosis","Cirrhosis Early","Cirrhosis Due to Hepatitis B","Cirrhosis Advanced","Cirrhosis Infectious","Cirrhosis Alcoholic","Cirrhosis Due to Hepatitis C",[60,68,69],"Liver","Nonalcoholic Fatty Liver Disease","RECRUITING","2026-05-29",{"date":73,"type":37},"2026-06-02",{"date":75,"type":37},"2023-12-07",{"date":77,"type":22},"2029-08-31",{"name":79,"class":80},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH",13,{"id":83,"slug":84,"hasResults":12,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":90,"enrollmentInfo":91,"targetDuration":93,"studyType":94,"phases":4,"briefSummary":95,"conditions":96,"keywords":100,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":4},"100640414","effect-of-lsd-on-renal-function-in-cirrhosis-patients-with-portal-hypertension-bleeding-2-year-follow-up-100640414","NCT07585786","Effect of LSD on Renal Function in Cirrhosis Patients With Portal Hypertension Bleeding (2-Year Follow-Up)","A Prospective, Single-Center, Observational Cohort Study to Evaluate the Long-Term (2-Year) Effects of Laparoscopic Splenectomy and Azygoportal Disconnection on Renal Function in Patients With Liver Cirrhosis, Portal Hypertension Bleeding","LSD-RFPH","Inclusion Criteria:\n\n1. Confirmed diagnosis of liver cirrhosis (clinical, laboratory, imaging)\n2. Splenomegaly and hypersplenism\n3. History of portal hypertension bleeding (esophageal and gastric variceal bleeding )\n4. Age 18-80 years, male or female\n5. Child-Pugh Class A or B liver function\n6. No history of primary renal disease or acute kidney injury (AKI)\n7. Signed written informed consent\n8. Ability to complete 24-month follow-up\n\nExclusion Criteria:\n\n1. Child-Pugh Class C liver cirrhosis\n2. Primary renal diseases (glomerulonephritis, polycystic kidney disease, chronic pyelonephritis, etc.)\n3. Previous abdominal surgery precluding safe laparoscopic splenectomy and azygoportal disconnection\n4. Severe cardiac, pulmonary, cerebrovascular dysfunction; malignant tumors; primary hematological disorders\n5. Hepatic encephalopathy or refractory ascites within 1 month before surgery\n6. Pregnancy or lactation\n7. Poor compliance, inability to complete follow-up","80 Years",{"count":92,"type":22},30,"2 Years","OBSERVATIONAL","Patients with liver cirrhosis often have impaired or at-risk kidney function due to the close link between liver and kidney (hepatorenal syndrome). Laparoscopic Splenectomy and Azygoportal Disconnection (LSD) is commonly used to treat Cirrhosis with Portal Hypertension Bleeding in these patients, but its impact on kidney function over 2 years is unclear. This study will follow patients undergoing laparoscopic splenectomy to measure changes in kidney function before and after surgery, identify risk factors for kidney damage and whether LSD can improve kidney function in the long term, and help improve care to protect kidney function in cirrhotic patients .",[28,97,98,99],"Splenectomy; Status","Renal Function Abnormal","Portal Hypertension",[60,101,102,103,104,105],"Splenectomy","Laparoscopy","azygoportal disconnection","Renal function","Portal hypertension bleeding","2026-05-14",{"date":108,"type":37},"2026-05-18",{"date":110,"type":22},"2026-05-01",{"date":112,"type":22},"2029-02-28",{"name":114,"class":44},"Northern Jiangsu People's Hospital",{"id":116,"slug":117,"hasResults":12,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":90,"enrollmentInfo":123,"targetDuration":93,"studyType":94,"phases":4,"briefSummary":124,"conditions":125,"keywords":127,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":132,"completionDateStruct":133,"leadSponsor":134,"locationsCount":45},"100638416","effect-of-lsd-on-lipid-profiles-in-cirrhosis-patients-with-portal-hypertension-bleeding-2-year-follow-up-100638416","NCT07588334","Effect of LSD on Lipid Profiles in Cirrhosis Patients With Portal Hypertension Bleeding (2-Year Follow-Up)","A Prospective, Single-Center, Observational Cohort Study to Evaluate the Long-Term (2-Year) Effects of Laparoscopic Splenectomy and Azygoportal Disconnection on Lipid Profiles in Patients With Liver Cirrhosis, Portal Hypertension Bleeding.","LSD-LPPH","Inclusion Criteria:\n\n1. Age 18-80 years, male or female\n2. Confirmed diagnosis of liver cirrhosis (clinical, laboratory, imaging)\n3. Splenomegaly and hypersplenism\n4. History of portal hypertension bleeding (esophageal and gastric variceal bleeding )\n5. Child-Pugh Class A or B liver function\n6. Signed written informed consent\n7. Ability to complete 24-month follow-up\n\nExclusion Criteria:\n\n1. Child-Pugh Class C liver cirrhosis\n2. Previous abdominal surgery precluding safe laparoscopic splenectomy and azygoportal disconnection\n3. Severe cardiac, pulmonary, cerebrovascular dysfunction; malignant tumors; primary hematological disorders\n4. Metabolic\u002Fendocrine diseases: Familial hyperlipidemia; uncontrolled severe diabetes mellitus, thyroid dysfunction, nephrotic syndrome; use of lipid-lowering drugs, hormones, or other drugs affecting blood lipids within 1 month before surgery.\n5. Infections\u002Finflammatory diseases: Active hepatitis, severe infections, or autoimmune diseases.\n6. Cirrhotic complications (hepatic encephalopathy, refractory ascites) within 1 month before surgery\n7. Pregnancy or lactation\n8. Poor compliance, inability to complete follow-up",{"count":92,"type":22},"Patients with liver cirrhosis frequently exhibit dyslipidemia due to impaired hepatic lipid synthesis, altered bile acid metabolism, and portal hypertension. Laparoscopic Splenectomy and Azygoportal Disconnection (LSD) is commonly used to treat Cirrhosis with Portal Hypertension Bleeding in these patients, but its impact on lipid profiles over 2 years remains poorly characterized. This study will follow patients undergoing LSD to measure changes in serum lipid parameters before and after surgery, identify risk factors for lipid profile deterioration or improvement, and determine whether LSD can ameliorate dyslipidemia in the long term, thereby informing metabolic management strategies in cirrhotic patients.",[28,97,99,126],"Lipid Profiles",[60,101,102,126,103,128,129],"Portal Hypertension Bleeding","hypersplenism","2026-05-10",{"date":106,"type":37},{"date":110,"type":22},{"date":112,"type":22},{"name":114,"class":44},{"id":136,"slug":137,"hasResults":12,"nctId":138,"briefTitle":139,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":141,"targetDuration":4,"studyType":23,"phases":143,"briefSummary":145,"conditions":146,"keywords":151,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":164},"100526552","testing-liverwatch-a-home-based-remote-monitoring-intervention-for-advanced-liver-disease-100526552","NCT06136221","Testing LiverWatch, a Home-Based Remote-Monitoring Intervention for Advanced Liver Disease","Inclusion Criteria:\n\n* English speaking\n* Aged 18 years or older\n* Home-dwelling\n* Diagnosis of cirrhosis- Child Turcotte-Pugh (CTP) B or C or a complication in the past 6 months (CTP B or higher, hepatic encephalopathy, variceal bleeding, fluid overload, liver-related hospitalization, or requiring symptom management with diuretics, non-absorbable disaccharides, rifaximin, nonselective beta blockers)\n* Patient and\u002For caregiver is able and willing to receive SMS text messages\n* Willing and able to wear personal fitness trackers and engage with study staff\n\nExclusion Criteria:\n\n* No access to a smartphone\n* Non-home dwelling\n* On hospice care\n* Model for end stage liver disease (MELD) score ≥30\n* Advanced hepatocellular carcinoma, BCLC C or higher\n* Hospitalization within the last 30 days\n* Deemed not appropriate by treating physician for medical reasons\n* Enrolled in other dietary or physical activity interventions\n* Receiving physical therapy as standard of care",{"count":142,"type":22},110,[144],"NA","Remote healthcare monitoring for cirrhosis has shown promise in overcoming barriers to accessing specialty care, improving healthcare quality, and reducing mortality. The LiverWatch study is investigating whether a remote nutrition, physical activity, and education intervention can improve health outcomes in those with cirrhosis. In this clinical trial, individuals will be randomized to either enhanced usual care or the LiverWatch intervention. Both groups are given fitbits and asked to increase their step counts. Those in the Liverwatch group will be incentivized for increase their physical activity while also undergoing a personalized nutrition intervention and weekly symptom monitoring and cirrhosis education.",[28,147,148,149,150],"End Stage Liver DIsease","Symptoms and Signs","Physical Inactivity","Muscle Loss",[152,153,154],"Telehealth","Remote Symptom Monitoring","Gamification","2026-05-07",{"date":157,"type":37},"2026-05-11",{"date":159,"type":37},"2024-05-01",{"date":161,"type":22},"2027-05-31",{"name":163,"class":44},"University of Pennsylvania",2,{"id":166,"slug":167,"hasResults":12,"nctId":168,"briefTitle":169,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":54,"enrollmentInfo":171,"targetDuration":4,"studyType":94,"phases":4,"briefSummary":172,"conditions":173,"keywords":177,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":181,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":45},"100589159","changes-in-glucose-tolerance-in-patients-with-cirrhosis-peri-liver-transplant-100589159","NCT06950788","Changes in Glucose Tolerance in Patients With Cirrhosis Peri-Liver Transplant","Inclusion Criteria:\n\n* Patients presenting to liver transplant clinic with a diagnosis of cirrhosis.\n* Age \\>18 yrs.\n* Ability to understand and sign written consent form, or have a legally-authorized representative or proxy who can be approached for consent\n\nExclusion Criteria:\n\n* Patients without consent\n* Patients with implantable cardioverter defibrillator devices or automated implantable cardioverter defibrillator devices will be excluded from the bio-electrical impedance analysis portion of the measurements.\n* Patients with unremovable electrical medical devices or devices that cannot turn off will be excluded from the bio-electrical impedance analysis measurements\n* Pregnant patients\n* Incarcerated patients\n* Patients with a history of type 2 diabetes mellitus diagnosed \\> 5 years ago will be excluded from the Oral Glucose Tolerance Test portion of the study",{"count":21,"type":22},"The goal of this observational study is to establish risk factors for post-transplant in adult individuals with cirrhosis without diabetes undergoing liver transplant evaluation.\n\nThe question being addressed is: can laboratory work, anthropometric tests, functional tests, imaging, and advanced measurements such as wrist actigraphy, continuous glucose monitoring, or oral glucose tolerance testing predict the development of diabetes after liver transplant?\n\nParticipants will be asked to periodically participate in wearing a continuous glucose monitor and wrist actigraph and obtain an oral glucose tolerance test both before and after liver transplant.",[28,174,175,176],"Diabetes Mellitus Risk","Transplant; Failure, Liver","Transplant-Related Disorder",[60,178,179,180],"Post-transplant diabetes","New-onset diabetes after transplant","Liver transplantation",{"date":155,"type":37},{"date":183,"type":37},"2024-03-12",{"date":185,"type":22},"2031-01",{"name":187,"class":44},"University of Chicago",{"id":189,"slug":190,"hasResults":12,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":195,"enrollmentInfo":196,"targetDuration":4,"studyType":23,"phases":198,"briefSummary":199,"conditions":200,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":4},"100634779","effect-of-babao-dan-capsule-combined-with-antiviral-therapy-on-the-incidence-of-hepatocellular-carcinoma-in-patients-with-hepatitis-b-related-cirrhosis-100634779","NCT07544121","Effect of Babao Dan Capsule Combined With Antiviral Therapy on the Incidence of Hepatocellular Carcinoma in Patients With Hepatitis B-related Cirrhosis","Effect of Babao Dan Capsule Combined With Antiviral Therapy on the Incidence of Hepatocellular Carcinoma in Patients With Hepatitis B-related Cirrhosis: A Multicenter, Randomized, Placebo-controlled Study","Inclusion Criteria:\n\n1. Voluntarily signed informed consent form\n2. Aged 18-65 years\n3. Traditional Chinese Medicine (TCM) syndrome type of Shi-re-du-yun\n4. Meeting the diagnostic criteria for hepatitis B-related cirrhosis\n5. aMAP score \\> 60\n\nExclusion Criteria:\n\n1. Previously diagnosed with or treated for hepatocellular carcinoma (HCC) or other malignancies\n2. Pregnant or lactating women\n3. Decompensated cirrhosis (e.g., presence of obvious ascites, hepatic encephalopathy, or gastrointestinal bleeding)\n4. Concomitant liver diseases, including but not limited to hepatitis C virus infection, human immunodeficiency virus infection, alcoholic liver disease, autoimmune liver disease, or drug-induced liver injury\n5. Severe cardiac, renal, respiratory, or hematopoietic system diseases\n6. Determined by the investigator to be unsuitable for participation in this trial","65 Years",{"count":197,"type":22},1034,[144],"This study aims to establish a prospective, multicenter, randomized, double-blind, placebo-controlled parallel-group clinical trial cohort. The cohort will include high-risk populations for hepatitis B cirrhosis-related hepatocellular carcinoma (HCC) from multiple centers nationwide, who meet the criteria of traditional Chinese medicine syndrome differentiation as Shi-re-du-yun syndrome and have an aMAP score \\>60 points. The objective is to evaluate whether combining Babao Dan Capsule with standard anti-hepatitis B virus therapy can further reduce the incidence of HCC in this high-risk population.",[201,28,202],"HEPATITIS B CHRONIC","Hepatocellular Carcinoma (HCC)","2026-04-19",{"date":205,"type":37},"2026-04-22",{"date":207,"type":22},"2026-04-01",{"date":209,"type":22},"2028-11-30",{"name":211,"class":44},"Nanfang Hospital, Southern Medical University",{"id":213,"slug":214,"hasResults":12,"nctId":215,"briefTitle":216,"officialTitle":216,"acronym":217,"eligibilityCriteria":218,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":219,"targetDuration":4,"studyType":94,"phases":4,"briefSummary":221,"conditions":222,"keywords":227,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":45},"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":220,"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.",[223,224,225,28,226],"Non-Alcoholic Fatty Liver Disease","Non-Alcoholic Steatohepatitis","Alcohol-related Liver Disease","Hepatocellular Carcinoma",[223,224,225,28,226],"2026-04-13",{"date":230,"type":37},"2026-04-16",{"date":232,"type":37},"2022-12-06",{"date":234,"type":22},"2032-03",{"name":236,"class":237},"Institut National de la Santé Et de la Recherche Médicale, France","OTHER_GOV",{"id":239,"slug":240,"hasResults":12,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":244,"eligibilityCriteria":245,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":246,"targetDuration":4,"studyType":23,"phases":248,"briefSummary":249,"conditions":250,"keywords":253,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":277},"100508347","online-prehabilitation-for-patients-awaiting-liver-transplantation-100508347","NCT05899231","Online Prehabilitation for Patients Awaiting Liver Transplantation","OPAL: Online Prehabilitation for Patients Awaiting Liver Transplantation - a Multicenter Randomized Controlled Trial to Reduce Physical Frailty and Improve Health Outcomes","OPAL","Inclusion Criteria:\n\n≥18 years old with cirrhosis (confirmed with transient elastography by FibroScan, histology, or imaging-based assessment with compatible clinical picture), referred for transplant and are assessed to have a high likelihood of being listed according to a preliminary review by hepatologist or are already listed for LT, are pre-frail or frail on the liver frailty index (LFI) or (added August 30, 2024) pre-frail or frail on the TeLeFI (prefrail LFI 3.2-4.3 and frail LFI ≥4.4), have English or French language proficiency, and own an internet-connected device.\n\nExclusion Criteria:\n\n* Listed for living related donor transplantation with expected time on the wait list \\\u003C12 weeks, or model for end-stage liver disease (MELD-Na) Score \\>26 (Justification: time to transplant is very short)\n* Robust status on frailty testing (LFI 0-3.1) (Justification: unlikely to see benefit)\n* Unable to provide informed consent\n* Presence of a clinical condition that makes the intervention unsafe or infeasible (e.g. unable to follow instruction) or unsafe environment for virtual participation\n* Life expectancy less than 6 months, compassionate care (clinician judgment) (Justification: unlikely to see benefit)\n* Recent variceal bleed or history of varices not on adequate prophylaxis (Justification: acute exercise increases portal pressure\n* Transplant indication is cholangiocarcinoma.",{"count":247,"type":22},177,[144],"Physical frailty is common in patients awaiting liver transplantation and has been associated with poor health outcomes. There is promising data from small studies showing that behavioural, nutrition, exercise therapy (prehabilitation) improves physical function in patients while they are waiting for a liver transplant.\n\nThe proposed trial will assess if a 12-week online prehabilitation program improves physical function in patients listed for liver transplantation. Over 4 years, 177 patients will be recruited from 6 transplant centres across Canada and will be randomized to receive either the online prehabilitation program or usual care.\n\nThe primary outcome of physical function will be evaluated using the FTSST at baseline and 12 weeks (or last timepoint before transplant) assessed virtually or in-person. Secondary outcomes include liver specific physical frailty, aerobic fitness, health-related quality of life (QoL), participant experience and acceptability. Exploratory outcomes include other virtual and in-person physical function measures, covert hepatic encephalopathy (CHE), sarcopenia, malnutrition, adherence, behaviour factors, clinical and post-transplant outcomes. Results will be compared between the intervention and usual care groups.",[28,251,252],"Liver Transplant Surgery","Liver Disease",[254,255,256,257,258,259,260,261,262,263,264,265,266,267],"frailty","transplant","nutrition","exercise","ehealth","application","wellness","prehabilitation","sarcopenia","malnutrition","physical function","digital","virtual","online","2026-04-07",{"date":270,"type":37},"2026-04-08",{"date":272,"type":37},"2023-07-12",{"date":274,"type":22},"2026-09",{"name":276,"class":44},"University of Alberta",6,{"id":279,"slug":280,"hasResults":12,"nctId":281,"briefTitle":282,"officialTitle":282,"acronym":4,"eligibilityCriteria":283,"healthyVolunteers":284,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":285,"targetDuration":4,"studyType":94,"phases":4,"briefSummary":287,"conditions":288,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":291,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":45},"100429121","development-of-4d-flow-mri-for-risk-stratification-of-variceal-bleeding-in-cirrhosis-100429121","NCT04867954","Development of 4D Flow MRI for Risk Stratification of Variceal Bleeding in Cirrhosis","Inclusion Criteria for Aim 1:\n\n* Healthy volunteers: Adults (\\>18 years) with no known liver pathology\n* Obese volunteers: Adults (\\>18 years), no known liver pathology, body mass index (BMI) ≥ 35\n* Patients: Adults (\\>18 years) with known cirrhosis and known Gastroesophageal varices\n\nExclusion Criteria for Aim 1:\n\n* contraindications to MRI\n* hypersensitivity reactions to both contrast agents\n* patients with recent treatment for varices with embolization, TIPS, or other endovascular treatment\n* patients with active GEV bleeding; known occlusive thrombus in portal vein, splenic vein, or superior mesenteric vein.\n* patients with large HCC with known PC involvement.\n\nInclusion criteria for Aim 2-4:\n\n* Adults (\\>18 years) with known cirrhosis\n\nExclusion Criteria for Aim 2-4:\n\n* Contraindications to MRI\n* Recent treatment (\\\u003C 1 year) for varices\n* Known occlusive thrombus in portal vein; splenic vein, or superior mesenteric vein\n* Large hepatocellular carcinoma (HCC) with known PV involvement\n* Hypersensitivity reactions to both contrast agents\n* Participants requiring conscious sedation for imaging are not eligible; participants requiring mild, oral anxiolytics for the clinical MRI scan will be allowed to participate as long as the following criteria are met:\n\n  * The participant has their own prescription for the medication\n  * The informed consent process is conducted prior to the self-administration of the medication.\n  * The participant comes to the research visit with a driver.\n\nInclusion Criteria for Aim 5:\n\n* Adults (\\>18 years) with Fontan repair and diagnosed FALD\n\nExclusion Criteria for Aim 5:\n\n* Contraindications to MRI\n* Recent treatment (\\\u003C 1 year) for varices\n* Known occlusive thrombus in portal vein; splenic vein, or superior mesenteric vein\n* Large hepatocellular carcinoma (HCC) with known PV involvement\n* Hypersensitivity reactions to both contrast agents\n* Participants requiring conscious sedation for imaging are not eligible; participants requiring mild, oral anxiolytics for the clinical MRI scan will be allowed to participate as long as the following criteria are met:\n\n  * The participant has their own prescription for the medication\n  * The informed consent process is conducted prior to the self-administration of the medication.\n  * The participant comes to the research visit with a driver.",true,{"count":286,"type":22},146,"The goal of this research is to validate novel non-invasive Magnetic resonance imaging (MRI) biomarkers to detect Gastroesophageal varices (GEV) in patients with cirrhosis, including fractional flow change in the portal vein and elevated azygos flow.\n\nEnd-stage liver disease (cirrhosis) is characterized by advanced fibrosis, liver failure, and portal hypertension. There are many causes of cirrhosis, including viral hepatitis, alcohol abuse, and perhaps most importantly, non-alcoholic fatty liver disease (NAFLD) and its aggressive subset, non-alcoholic steatohepatitis (NASH). 3 million new cases of end-stage liver disease (cirrhosis) are expected over the next decade. In cirrhosis, portosystemic collaterals that shunt blood away from the liver develop due to increased portal pressure. Gastroesophageal varices (GEV) are the most clinically relevant because they can cause fatal internal bleeding. GEV bleeding carries \\~20% mortality at 6 weeks, and \\~34% overall mortality. Identification of at-risk varices, prior to bleeding, is of paramount importance to initiate primary prophylaxis. To identify and treat at-risk patients, current guidelines recommend regular esophagogastroduodenoscopy (EGD) and variceal band ligation. Detection of high-risk GEV is key to initiating primary prophylaxis, which can reduce mortality by 50-70%.\n\nHowever, endoscopy is invasive and often unnecessary when no treatment is required. Therefore, the American Association for the Study of Liver Diseases has identified the development of \"non-invasive markers that predict the presence of high-risk varices\" as a major unmet need.",[28,289,290],"Gastroesophageal Varices","Fontan Procedure",{"date":292,"type":37},"2026-04-09",{"date":294,"type":37},"2021-10-28",{"date":296,"type":22},"2026-06-30",{"name":298,"class":44},"University of Wisconsin, Madison",{"id":300,"slug":301,"hasResults":12,"nctId":302,"briefTitle":303,"officialTitle":303,"acronym":4,"eligibilityCriteria":304,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":195,"enrollmentInfo":305,"targetDuration":4,"studyType":23,"phases":306,"briefSummary":307,"conditions":308,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":312,"completionDateStruct":313,"leadSponsor":314,"locationsCount":4},"100629927","effect-of-fufang-biejiaruangan-combined-with-antiviral-therapy-on-the-incidence-of-hepatocellular-carcinoma-in-patients-with-hepatitis-b-related-cirrhosis-a-multicenter-randomized-placebo-controlled-study-100629927","NCT07481032","Effect of Fufang Biejiaruangan Combined With Antiviral Therapy on the Incidence of Hepatocellular Carcinoma in Patients With Hepatitis B-related Cirrhosis: A Multicenter, Randomized, Placebo-controlled Study","Inclusion Criteria:\n\n* Voluntarily signed informed consent form\n* Aged 18-65 years\n* Traditional Chinese Medicine (TCM) syndrome type: Qi-zhi -xue-yu\n* Meeting the diagnostic criteria for hepatitis B-related cirrhosis\n* aMAP score \\> 60\n\nExclusion Criteria:\n\n* \\[Previously diagnosed with or treated for hepatocellular carcinoma (HCC) or other malignancies\n* Pregnant or lactating women\n* Decompensated cirrhosis (e.g., presence of obvious ascites, hepatic encephalopathy, or gastrointestinal bleeding)\n* Concomitant liver diseases, including but not limited to hepatitis C virus infection, human immunodeficiency virus infection, alcoholic liver disease, autoimmune liver disease, or drug-induced liver injury\n* Severe cardiac, renal, respiratory, or hematopoietic system diseases\n* Determined by the investigator to be unsuitable for participation in this trial",{"count":197,"type":22},[144],"This study aims to establish a prospective, multicenter, randomized, double-blind, placebo-controlled parallel-group clinical trial cohort. The cohort will include high-risk populations for hepatitis B cirrhosis-related hepatocellular carcinoma (HCC) from multiple centers nationwide, who meet the criteria of traditional Chinese medicine syndrome differentiation as Qi-zhi-xue\\_yu syndrome and have an aMAP score \\>60 points. The objective is to evaluate whether combining Bie-jia-ruan-gan with standard anti-hepatitis B virus therapy can further reduce the incidence of HCC in this high-risk population.",[28,202,201],"2026-03-15",{"date":311,"type":37},"2026-03-18",{"date":207,"type":22},{"date":209,"type":22},{"name":211,"class":44},{"id":316,"slug":317,"hasResults":12,"nctId":318,"briefTitle":319,"officialTitle":320,"acronym":321,"eligibilityCriteria":322,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":323,"targetDuration":4,"studyType":23,"phases":325,"briefSummary":326,"conditions":327,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":45},"100556478","initial-resuscitation-for-acute-kidney-injury-in-cirrhosis-100556478","NCT06525623","Initial Resuscitation for Acute Kidney Injury in Cirrhosis","Initial Resuscitation for Acute Kidney Injury in Patients With Cirrhosis: A Pilot Randomized Trial Using a Volume Assessment Guidance Algorithm","RAKI-VAGA","Inclusion Criteria:\n\n1. Adult age 18 years or greater\n2. Signed informed consent form (ICF) by any subject capable of giving consent, or, when the subject is not capable of giving consent, by their legally authorized representatives prior to initiation of any study procedures.\n3. Admitted to the hospital\n4. Diagnosis of decompensated cirrhosis (either prior to admission or new diagnosis on admission).\n5. Presence of acute kidney injury (AKI) as defined by International Club of Ascites (ICA) criteria, defined as SCr increase of ≥0.3 mg\u002FdL within 48 hours or ≥50% increase from baseline which is known or presumed to have occurred within the prior 7 days.\n\nExclusion Criteria:\n\n1. Requiring \\>2 liters (L) supplemental oxygen at the time of screening.\n2. In shock requiring vasopressors (vasoconstrictors for the treatment of AKI such as terlipressin, midodrine, and octreotide are allowed).\n3. Allergy or other contraindication to IV albumin administration.\n4. Death, liver transplant, or renal replacement therapy (RRT) expected within 48 hours.\n5. Patient and\u002For legally authorized representative unable to provide informed consent.\n6. Hepatic encephalopathy grade 3 or 4 at the time of screening.\n7. Already received \\>200 g albumin during admission at the time of screening.\n8. Severe, active bleeding requiring 3 or more units of red blood cell transfusion in the 48 hours prior to screening.\n9. Admission to the intensive care unit at the time of screening.\n10. Mechanical ventilation at the time of screening.\n11. Presence of New York Heart Association (NYHA) class 3-4 symptoms of congestive heart failure at the time of screening.\n12. History of prior liver or kidney transplant.\n13. Pregnant or nursing status\n14. Any condition, in the opinion of the investigator, that could confound or interfere with the safe completion of study activities.",{"count":324,"type":22},50,[144],"The goal of this interventional study is to evaluate two strategies for how to provide intravenous (IV) fluids for treating patients with acute kidney injury (AKI) in cirrhosis. The main question it aims to answer is: what is the safety, efficacy, and feasibility of providing a recommendation to use a Volume Assessment Guidance Algorithm (VAGA) or give standard of care doses of IV albumin?\n\nPatients will be randomly assigned where their treating teams will receive a VAGA-based recommendation or a standard of care IV albumin recommendation.",[28,328,329],"Acute Kidney Injury","Hepatorenal Syndrome","2026-03-11",{"date":332,"type":37},"2026-03-13",{"date":334,"type":37},"2024-09-12",{"date":336,"type":22},"2027-05-01",{"name":338,"class":44},"Massachusetts General Hospital",{"id":340,"slug":341,"hasResults":12,"nctId":342,"briefTitle":343,"officialTitle":344,"acronym":4,"eligibilityCriteria":345,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":346,"targetDuration":4,"studyType":23,"phases":348,"briefSummary":349,"conditions":350,"keywords":351,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":355,"lastUpdatePostDateStruct":356,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":362,"locationsCount":45},"100529476","transitional-care-program-for-fluid-overload-in-cirrhosis-100529476","NCT06174272","Transitional Care Program for Fluid Overload in Cirrhosis","Transitional Care Program vs Standard of Care in Cirrhosis With Volume Overload: A Pilot Study","Inclusion Criteria:\n\n* Patients \\> 18 years of age.\n* Inpatient at Penn State Health, Milton S. Hershey Medical Center.\n* Diagnosis of cirrhosis.\n* Hospitalized with fluid overload (ascites and\u002For significant anasarca\u002Fedema) requiring diuretic therapy.\n* English speaking\n\nExclusion Criteria:\n\n* Placement of a TIPS.\n* Ascites from an etiology other than cirrhosis, such as malignancy, heart failure, pancreatitis, nephrotic syndrome.\n* Non-English speaking",{"count":347,"type":22},20,[144],"The goal of this clinical trial is to learn about an intensive monitoring plan (transitional care program) in patients with cirrhosis and excessive swelling that are going to be discharged from the hospital.\n\nThe main question\\[s\\] it aims to answer are:\n\n* How much time and what resources are needed to run such a program\n* How well do patients follow up with the phone calls, bloodwork, and doctor appointments?\n* Do the patients enrolled in the program have less need for hospitalization later, less kidney injury, better fluid control, and\u002For better survival compared to patients that are not in the program?\n\nParticipants will\n\n* Be given a digital scale and a binder with educational material and a log to monitor their weights after discharge from the hospital\n* Receive a phone call from the study team within 72 hours of discharge and weekly\n* Be given a follow up appointment with hepatology within 4 weeks of discharge\n\nResearchers will compare participants in this program to patients that receive normal care to see if there are differences in need for hospitalization later, kidney injury, fluid control, and\u002For survival.",[28],[352,353,354],"ascites","anasarca","edema","2026-03-06",{"date":357,"type":37},"2026-03-09",{"date":359,"type":37},"2025-02-15",{"date":361,"type":22},"2027-06-01",{"name":363,"class":44},"Milton S. Hershey Medical Center",{"id":365,"slug":366,"hasResults":12,"nctId":367,"briefTitle":368,"officialTitle":369,"acronym":370,"eligibilityCriteria":371,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":372,"targetDuration":4,"studyType":94,"phases":4,"briefSummary":373,"conditions":374,"keywords":382,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":386,"lastUpdatePostDateStruct":387,"startDateStruct":389,"completionDateStruct":391,"leadSponsor":393,"locationsCount":45},"100625994","changes-in-bile-acids-and-microbiota-in-patients-with-hepatitis-d-treated-with-bulvertide-100625994","NCT07429864","Changes in Bile Acids and Microbiota in Patients With Hepatitis D Treated With Bulvertide","Changes in Bile Acid Profile and Gut Microbiota in Patients Undergoing Treatment With Bulevirtide for Hepatitis Delta Virus Infection","Bio-Delta","Inclusion Criteria:\n\n* Patients with chronic HDV-related hepatitis or compensated liver cirrhosis (Child-Pugh class A)\n* Positive HDV RNA within the 24 weeks prior to enrollment\n* Ongoing antiviral therapy for HBV at the time of enrollment\n* First prescription of Bulevirtide 2 mg issued within 30 days prior to enrollment\n* Caucasian ethnicity\n* Age ≥18 years\n* Normocaloric omnivorous diet\n* No intake of antibiotics, probiotics, or prebiotics in the month prior to enrollment\n* Signed informed consent\n\nExclusion Criteria:\n\n* Decompensated liver cirrhosis (Child-Pugh Score B or C)\n* Patients without HBV-HDV-related infection\u002Fhepatitis\u002Fcirrhosis\n* Age ≤18 years\n* Pregnant or breastfeeding women\n* Concomitant diseases with short life expectancy (solid or hematologic neoplasms, heart failure NYHA III\u002FIV, COPD GOLD C-D)\n* Conditions (celiac disease, chronic inflammatory bowel diseases) or use of medications (antibiotics, probiotics, prebiotics) capable of altering gut microbiota composition",{"count":347,"type":22},"HDV is an RNA virus that infects only in the presence of HBV, affecting about 13% of HBsAg carriers. In Italy, prevalence ranges from 3.2% to 9.3%. It increases the risk of cirrhosis, fulminant hepatitis, and HCC, particularly in high-risk groups (HIV, HCV, drug users, dialysis patients). Until 2020, pegIFN was the only therapy; since 2022, bulevirtide (BLV) has been available, blocking viral entry into hepatocytes and reducing HDV RNA and liver stiffness, with efficacy in 45-48% of patients, though the optimal treatment duration remains uncertain. The gut microbiota and bile acids also play a role in fibrosis and cirrhosis progression: dysbiosis, typical in cirrhotic patients, alters bile acid metabolism and increases intrahepatic toxicity.",[375,376,377,378,226,28,379,380,381],"HBV","HBV Coinfection","HCV","HIV Infections","Fibrosis, Liver","Bile Acid Malabsorption","Microbial Colonization",[383,384,385],"gut microbiota","Bile Acids","dysbiosis","2026-02-17",{"date":388,"type":37},"2026-02-24",{"date":390,"type":37},"2025-09-24",{"date":392,"type":22},"2027-10",{"name":394,"class":44},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":396,"slug":397,"hasResults":12,"nctId":398,"briefTitle":399,"officialTitle":400,"acronym":401,"eligibilityCriteria":402,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":403,"targetDuration":4,"studyType":94,"phases":4,"briefSummary":405,"conditions":406,"keywords":408,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":411,"lastUpdatePostDateStruct":412,"startDateStruct":414,"completionDateStruct":416,"leadSponsor":418,"locationsCount":45},"100624139","cirrhotic-and-non-cirrhotic-patients-with-clinically-significant-portal-hypertension-100624139","NCT07405749","Cirrhotic and Non-cirrhotic Patients With Clinically Significant Portal Hypertension","Incidence and Predictive Factors of Elective Procedure-Related Bleeding in Cirrhotic and Non-Cirrhotic Patients With Clinically Significant Portal Hypertension","PREDIBLEED","Inclusion Criteria:\n\n* Age \\> 18 years;\n* Ability to provide informed consent;\n* Specific signs of CSPH (gastroesophageal varices, porto-systemic collaterals, liver stiffness measurement (LSM) \\> 25 KPa or spleen stiffness measurement (SSM) \\> 50 KPa);\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years;\n* Life expectancy \\\u003C 6 months;\n* Patients unable to sign informed consent.",{"count":404,"type":22},2500,"Alterations in conventional coagulation tests in patients with cirrhosis and\u002For portal hypertension do not reliably predict bleeding risk, as hemostatic balance is complex and often compensated. Many procedure-related bleeding events are driven by non-coagulatory factors, such as portal hypertension or technical aspects of the procedure. Most commonly performed procedures carry a low risk of bleeding even in the presence of elevated INR or thrombocytopenia, and no validated laboratory thresholds support prophylactic correction. Risk assessment should therefore be based on procedural factors, severity of liver disease, and systemic patient conditions, with correction of modifiable risk factors particularly before high-risk elective procedures.",[28,99,407,289],"Clinically Significant Portal Hypertension(CSPH)",[409,410],"Thrombotic events","porto-systemic collaterals","2026-02-05",{"date":413,"type":37},"2026-02-12",{"date":415,"type":22},"2026-02",{"date":417,"type":22},"2030-02",{"name":394,"class":44},{"id":420,"slug":421,"hasResults":12,"nctId":422,"briefTitle":423,"officialTitle":424,"acronym":4,"eligibilityCriteria":425,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":54,"enrollmentInfo":426,"targetDuration":4,"studyType":94,"phases":4,"briefSummary":428,"conditions":429,"keywords":431,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":411,"lastUpdatePostDateStruct":435,"startDateStruct":437,"completionDateStruct":439,"leadSponsor":441,"locationsCount":45},"100475752","3d-mre-for-assessing-cirrhosis-advanced-chronic-liver-disease-and-portal-hypertension-100475752","NCT05475015","3D-MRE for Assessing Cirrhosis, Advanced Chronic Liver Disease and Portal Hypertension","Three-dimensional MR Elastography for Assessing Cirrhosis and Portal Hypertension (CHESS2206): A Prospective Multicenter Study","Inclusion criteria were: (1) ≥18 years; (2) written informed consent; (3) confirmed ACLD of any liver disease etiology; (4) clinically indicated for HVPG measurement, with 3D-MRE performed within one month prior.\n\nExclusion criteria were: (1) hepatic or extrahepatic malignancies, or large hepatic or splenic focal diseases affecting MRE measurement; (2) MR or HVPG contraindications; (3) prior liver or splenic surgery affecting MRE measurement; (4) treatment with nonselective β-blockers (NSBB) between MRE and HVPG measurements; (5) invalid or unreliable HVPG or MRE results and (6) biliary obstruction or dilation on MR images.",{"count":427,"type":22},150,"How to construct a novel, non-invasive, accurate, and convenient method to achieve prediction of hepatic venous pressure gradient (HVPG) is an important general problem in the management of portal hypertension in cirrhosis or advanced chronic liver disease. We plan to investigate the ability of three demensional-magnetic resonance elastography (3D-MRE) to establish a risk stratification system and perform tailored management for portal hypertension in cirrhosis or advanced chronic liver disease.",[28,99,430],"Advanced Chronic Liver Disease",[432,433,434],"3D-MRE","HVPG","advanced chronic liver disease",{"date":436,"type":37},"2026-02-09",{"date":438,"type":37},"2022-08-16",{"date":440,"type":22},"2026-12-01",{"name":442,"class":44},"Shengjing Hospital",{"id":444,"slug":445,"hasResults":12,"nctId":446,"briefTitle":447,"officialTitle":448,"acronym":449,"eligibilityCriteria":450,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":54,"enrollmentInfo":451,"targetDuration":4,"studyType":23,"phases":452,"briefSummary":454,"conditions":455,"keywords":463,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":480,"lastUpdatePostDateStruct":481,"startDateStruct":483,"completionDateStruct":485,"leadSponsor":487,"locationsCount":490},"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.",{"count":92,"type":22},[453,25],"PHASE1","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.",[456,28,457,458,459,460,461,462],"End-stage Liver Disease (ESLD)","Cirrhosis, Decompensated","Liver Diseases","Fibrosis and Cirrhosis of Liver","Decompensated Liver Cirrhosis","Decompensated Cirrhosis","Steatotic Liver Disease",[464,465,466,467,468,460,469,470,471,472,473,474,475,476,477,478,479,462],"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","2026-01-27",{"date":482,"type":37},"2026-01-28",{"date":484,"type":37},"2024-10-15",{"date":486,"type":22},"2028-11-29",{"name":488,"class":489},"Resolution Therapeutics Limited","NETWORK",14,{"id":492,"slug":493,"hasResults":12,"nctId":494,"briefTitle":495,"officialTitle":496,"acronym":497,"eligibilityCriteria":498,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":499,"targetDuration":4,"studyType":94,"phases":4,"briefSummary":501,"conditions":502,"keywords":504,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":510,"lastUpdatePostDateStruct":511,"startDateStruct":513,"completionDateStruct":515,"leadSponsor":517,"locationsCount":45},"100619316","diagnosis-of-lymphohistiocytic-hemophagocytosis-in-intensive-care-100619316","NCT07343037","Diagnosis of Lymphohistiocytic Hemophagocytosis in Intensive Care","Diagnosis of Lymphohistiocytic Hemophagocytosis in Intensive Care: Relevance of the Hscore and Search for the Best Diagnostic Markers","SAMICU","Inclusion Criteria:\n\n* Adult patient (≥18 years old)\n* Patient admitted to the intensive care unit at Hautepierre Hospital, Strasbourg University Hospital, between January 1, 2014, and December 31, 2024\n* At least 3 biological signs of HLH:\n\n  * ferritin \\> 2000 ng\u002FmL\n  * triglycerides \\> 1.5 g\u002FL\n  * at least one cytopenia (leukocytes ≤ 5000 G\u002FL, platelets ≤ 110 G\u002FL, hemoglobin ≤ 9.2 g\u002FdL).\n\nExclusion Criteria:\n\nRefusal to participate in the study",{"count":500,"type":22},100,"Patients with hepatocellular insufficiency and\u002For cirrhosis are at risk of developing invasive fungal infections, particularly in critical care settings.\n\nIn international recommendations, voriconazole is positioned as the first-line treatment for invasive aspergillosis. However, this molecule-and the azole class of antifungals-is associated with frequent hepatic toxicity. Available since 2018, isavuconazole appears to be better tolerated in patients without pre-existing liver dysfunction.\n\nThe aim of this study is to retrospectively evaluate the validity of the hscore in intensive care and resuscitation patients.",[503,28],"Hepatic Insufficiency",[503,28,505,506,507,508,509],"Lymphohistiocytic hemophagocytosis","Hepatocellular insufficiency","Invasive aspergillosis","Azole antifungals","Liver dysfunction.","2026-01-06",{"date":512,"type":37},"2026-01-15",{"date":514,"type":37},"2025-08-29",{"date":516,"type":22},"2026-08-29",{"name":518,"class":44},"University Hospital, Strasbourg, France",{"id":520,"slug":521,"hasResults":12,"nctId":522,"briefTitle":523,"officialTitle":524,"acronym":4,"eligibilityCriteria":525,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":526,"targetDuration":4,"studyType":23,"phases":528,"briefSummary":529,"conditions":530,"keywords":531,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":536,"startDateStruct":537,"completionDateStruct":539,"leadSponsor":541,"locationsCount":45},"100556515","phase-2-study-of-tremelimumab-and-durvalumab-medi4736-t300d-in-advanced-hepatocellular-carcinomas-with-child-pugh-b-cirrhosis-100556515","NCT06526104","Study of Tremelimumab and Durvalumab (MEDI4736) (T300+D) in Advanced Hepatocellular Carcinomas With Child-Pugh-B Cirrhosis","Phase II Single Arm Study of Tremelimumab and Durvalumab (MEDI4736) (T300+D) in Advanced Hepatocellular Carcinomas With Child-Pugh-B Cirrhosis (STRIDE in CP-B)","Inclusion Criteria:\n\n1. Patients diagnosed with HCC based on pathologic diagnosis from biopsy or radiographic diagnosis on CT liver or MRI liver (i.e., Barcelona Clinic Liver Cancer (BCLC) stage B and not candidate for locoregional therapies or BCLC stage C)10\n2. Patients with Child-Pugh-B7 or -B8 liver cirrhosis11\n3. ECOG performance status score 0-1\n4. Patients with Hepatitis B Virus (HBV) infection are required to receive effective antiviral therapy and have a viral load less than 500 IU\u002FmL at screening; antiviral therapy is not required for patients with Hepatitis C Virus (HCV) infection.\n5. Adequate organ and bone marrow function:\n\n   1. Absolute neutrophil counts ≥1000\u002FuL\n   2. Platelets ≥60 × 100\u002FuL\n   3. Hemoglobin ≥8.0 g\u002FdL\n   4. ALT and AST ≤5× upper limit of normal each\n   5. Bilirubin ≤3 mg\u002FdL,\n   6. International normalized ratio (INR) ≤2.3 or prothrombin time ≤6 seconds above control)\n   7. Measured creatinine clearance (CL) \\>40 mL\u002Fmin or Calculated creatinine clearance CL\\>40 mL\u002Fmin by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance:\n\n   Males:\n\n   Creatinine CL (mL\u002Fmin)=Weight (kg) x (140 - Age) \u002F72 x serum creatinine (mg\u002FdL)\n\n   Females:\n\n   Creatinine CL (mL\u002Fmin)=Weight (kg) x (140 - Age) x 0.85 \u002F72 x serum creatinine (mg\u002FdL)\n6. Body weight \\>30 kilogram (kg)\n7. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization (e.g., Health Insurance Portability and Accountability Act in the US) obtained from the patient\u002Flegal representative prior to performing any protocol-related procedures, including screening evaluations.\n8. Age \\>18 years at time of study entry or adult male or female (according to age of majority as defined as ≥18 years)\n9. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.\n10. Must have a life expectancy of at least 12 weeks.\n11. At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 target lesion (TL) at baseline.\n\nExclusion Criteria:\n\n1. Patients who are candidates for curative treatments\n2. History of uncontrolled hepatic encephalopathy in the past 6 months; patients who are stable on medical therapy are eligible.\n3. Active substance abuse or alcohol abuse at the time of consent or enrollment, which in the opinion of the treating physician would interfere with the safety of the patient and\u002For adherence to the study protocol.\n4. Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen.\n5. Prior systemic therapy for locally advanced or metastatic HCC\n6. Participation in another clinical study with an investigational product during the last 1 month.\n7. Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.\n8. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable. \\\u003C\\\u003Camend as required based on any combination studies with other anticancer agents\\>\\>\n9. Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug\n10. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.\n11. History of allogenic organ transplantation\n12. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g., colitis or Crohn's disease\\], diverticulitis \\[with the exception of diverticulosis\\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \\[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\\]). The following are exceptions to this criterion:\n\n    1. Patients with vitiligo or alopecia\n    2. Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement.\n    3. Any chronic skin condition that does not require systemic therapy\n    4. Patients without active disease in the last 5 years may be included but only after consultation with the study physician.\n    5. Patients with celiac disease controlled by diet alone.\n13. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent\n14. History of leptomeningeal carcinomatosis\n15. History of active primary immunodeficiency\n16. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab or tremelimumab. The following are exceptions to this criterion:\n\n    1. Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)\n    2. Systemic corticosteroids at physiologic doses not to exceed \\\u003C\\\u003C10 mg\u002Fday\\>\\> of prednisone or its equivalent.\n    3. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)\n17. Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 90 days after the last dose of IP.\n18. Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy or180 days after the last dose of durvalumab and tremelimumab combination therapy.\n19. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.\n20. Prior randomisation or treatment in a previous durvalumab and\u002For tremelimumab clinical study regardless of treatment arm assignment.\n21. Known allergy or hypersensitivity to IP or any excipient.\n22. History of another primary malignancy except for:\n\n    1. Malignancy treated with curative intent with no known active disease ≥2 years before the first dose of study intervention and of low potential risk for recurrence.\n    2. Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or lentigo maligna that has undergone potentially curative therapy.",{"count":527,"type":22},32,[25],"This is a single-arm, phase II study of patients with advanced liver cancer or hepatocellular carcinoma (HCC) who are eligible for first-line treatment with T300+D. The invesitgators hypothesize that T300+D will be safe and tolerated in CP-B patients with HCC. HCC mostly affects disadvantaged populations with higher rates among racial\u002Fethnic minorities, who are often not included in clinical trials (i.e., Hispanics, Blacks, underserved, low socioeconomic status) and present with more severe disease. Given there is not much data in the US patient cohort, this study provides a chance to gain that knowledge.",[226,28],[532,533,534],"Tremelimumab","Durvalumab","Child-Pugh-B Cirrhosis","2026-01-02",{"date":510,"type":37},{"date":538,"type":37},"2024-12-02",{"date":540,"type":22},"2027-12-01",{"name":542,"class":44},"The University of Texas Health Science Center at San Antonio",{"id":544,"slug":545,"hasResults":12,"nctId":546,"briefTitle":547,"officialTitle":548,"acronym":549,"eligibilityCriteria":550,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":551,"enrollmentInfo":552,"targetDuration":4,"studyType":94,"phases":4,"briefSummary":554,"conditions":555,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":557,"lastUpdatePostDateStruct":558,"startDateStruct":560,"completionDateStruct":562,"leadSponsor":563,"locationsCount":164},"100403243","intraabdominal-hypertension-and-occurrence-of-microaspiration-in-cirrhotics-under-mechanical-ventilation-100403243","NCT04530760","Intraabdominal Hypertension and Occurrence of Microaspiration in Cirrhotics Under Mechanical Ventilation","Impact of Intraabdominal Hypertension on Microaspiration Incidence in Cirrhotic Patients","ATOMIC","Inclusion Criteria:\n\n* adult patients\n* Cirrhosis\n* intubation and mechanical ventilation\n\nExclusion Criteria:\n\n* pregnancy\n* oliguric patients\n* impossibility to measure intravesical pressure","99 Years",{"count":553,"type":22},226,"The study aims to demonstrate the relationship between intra-abdominal hypertension (IAH) and abundant microaspirations in mechanically ventilated cirrhotic.",[556,28],"Critical Illness","2025-12-16",{"date":559,"type":37},"2025-12-23",{"date":561,"type":37},"2021-10-08",{"date":39,"type":22},{"name":564,"class":44},"University Hospital, Lille",{"id":566,"slug":567,"hasResults":12,"nctId":568,"briefTitle":569,"officialTitle":570,"acronym":571,"eligibilityCriteria":572,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":195,"enrollmentInfo":573,"targetDuration":4,"studyType":23,"phases":575,"briefSummary":576,"conditions":577,"keywords":580,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":586,"lastUpdatePostDateStruct":587,"startDateStruct":588,"completionDateStruct":590,"leadSponsor":592,"locationsCount":45},"100614980","echocardiography-guided-cirrhosis-and-liver-failure-intensive-care-protocol-sepsis-100614980","NCT07286643","Echocardiography-guided Cirrhosis and Liver Failure-Intensive Care Protocol Sepsis","Point-of-care Echocardiogram (POCUS) Guided Resuscitation Versus Conventional Goal- Directed Therapy in the Management of Cirrhosis With Severe Sepsis or Septic Shock: A Randomised Controlled Trial","ECLIPSE-I","Inclusion Criteria:\n\n1. Critically ill patient with cirrhosis of any etiology\n2. Sepsis-related Hypotension (MAP \\\u003C65mmHg or SBP \\\u003C90mmHg)\n3. 18-65 yrs of age -\n\nExclusion Criteria:\n\n1. Already on vasopressors\u002Finotropes\n2. Severe pre-existing cardiopulmonary disease like porto-pulmonary hypertension (PPH), known coronary artery disease, congenital or valvular heart disease, prosthetic cardiac valves, dilated or restrictive cardiomyopathy.\n3. Poor chest wall window due to left pleural effusion, left pneumothorax, small intercostal spaces that restrict performance of a POCUS.\n4. Active bleeding like variceal bleed\n5. Cerebrovascular events\n6. Chronic renal disease - End Stage Renal Disease (ESRD)\u002F patient on renal replacement therapy\n7. Admission to ICU following liver transplantation, burns, cardiac surgery\n8. Previous transjugular intra hepatic portosystemic shunt (TIPS),\n9. Hepatocellular carcinoma\n10. Pregnant or lactating women\n11. Informed consent refused by patient or attendants\n12. Active COVID-19 infection",{"count":574,"type":22},140,[144],"* Point-of-care echocardiography is used to guide septic shock resuscitation in patients with severe sepsis in the intensive care unit (ICU), but without systematic evidence for efficacy in critically patients with Cirrhosis and Severe Sepsis.\n* Due to portal hypertension, these patients have a hyperdynamic circulation, increased capillary permeability, splanchnic arteriolar vasodilation, reduced effective circulating blood volume and may have latent cirrhotic cardiomyopathy (CCM).\n* Hence assessment of volume status and cardiac reserve using conventional central venous pressure (CVP) or mean arterial pressure (MAP) remains difficult.\n\nNovelty:\n\n* In two recent trials, the role of 5% albumin vs PlasmalyteTM (FRISC study)(1) and 20% albumin vs. PlasmalyteTM (ALPS study) (2) were reported as the primary resuscitation fluid. Neither trial showed a clear long term survival benefit of albumin over balanced salt solution (BSS). In fact, the ALPS trial reported that there was increased risk of pulmonary edema with use of 20% albumin as fluid resuscitation.\n* A major limitation of such trial data is that the focus is on choice of fluid rather than looking at hemodynamic goals of resuscitation, resulting in protocolized overzealous fluid administration.\n* This may result in albumin-related pulmonary edema, and precipitation of overt heart failure in patients with silent CCM.\n* POC-Echo-based fluid resuscitation can prevent pulmonary edema and consequently respiratory failure, while ensuring renal and tissue perfusion.\n* It is unclear if choice of fluid or appropriate targets of resuscitation drive the survival benefit in the intensive care management of cirrhosis with severe sepsis.\n\nObjectives:\n\n* The investigators will conduct an ICU based randomised controlled feasibility trial comparing two measures of resuscitation: Echocardiography (ECHO) Guided septic shock resuscitation vs. a modified Goal-Directed Fluid Therapy (GDT) as recommended by sepsis guidelines which use protocol fluids.\n* The study will validate the role of POC-Echo parameters as volume assessment tools (cardiac index, systemic vascular resistance index) to determine endpoints of fluid resuscitation and need for vasopressors.\n* Lastly, the study aims to determine the presence of CCM in this population, and its impact on clinical outcomes.\n\nMethods POC-ECHO will be done within 1 hours of admission to the liver ICU and at 24h, 48 h and 72 hours in patients with cirrhosis with systolic blood pressure of \\\u003C90 mmHg or a mean arterial pressure \\\u003C65 mmHg. Resuscitation target is maintenance of MAP ≥65 mmHg with use of fluids and\u002For vasopressors. Clinical, cardiac biomarkers, and survival data based on resuscitation fluids will be prospectively collected. CCM will be defined as per CCM Consortium (2020) criteria.\n\nExpected outcome.\n\nThe key questions to be answered in the resuscitation of critically ill patients with cirrhosis and sepsis induced hypotension are:\n\n1. What should be best method of ensuring adequate fluid resuscitation i.e. fluid resuscitation protocol?\n2. Which measurable clinical parameter can be used to determine adequacy of fluid resuscitation, and as a predictor of mortality outcomes at 7 and 28 days?\n3. Whether early fluid resuscitation translates into better clinical outcome in decreasing duration of hospital and intensive care unit (ICU) stay, prevention of AKI and prevention of secondary sepsis?",[28,578,579],"Cirrhotic Cardiomyopathy","Septic Shock",[581,582,583,584,585],"echocardiography","cardiac output monitoring","hemodynamics","fluid resuscitation.","POCUS","2025-12-13",{"date":557,"type":37},{"date":589,"type":22},"2026-01-01",{"date":591,"type":22},"2028-12-30",{"name":593,"class":44},"Post Graduate Institute of Medical Education and Research, Chandigarh",{"id":595,"slug":596,"hasResults":12,"nctId":597,"briefTitle":598,"officialTitle":598,"acronym":4,"eligibilityCriteria":599,"healthyVolunteers":12,"sex":18,"minAge":600,"maxAge":195,"enrollmentInfo":601,"targetDuration":4,"studyType":23,"phases":603,"briefSummary":604,"conditions":605,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":606,"lastUpdatePostDateStruct":607,"startDateStruct":609,"completionDateStruct":611,"leadSponsor":613,"locationsCount":45},"100514766","molecular-mechanism-of-exercise-in-cirrhosis-100514766","NCT05982769","Molecular Mechanism of Exercise in Cirrhosis","Inclusion\n\n* Adult patients age 21-65 years of both genders\n* Diagnosis of cirrhosis by either liver biopsy, clinical, biochemical or imaging criteria\n* Child's score 5-10\n* Model for End Stage Liver Disease (MELD) score less than 21\n* Abstinence from alcohol and\u002For other recreational drugs for at least 6 months\n* Absence of concurrent illnesses (renal, cardiac, pulmonary, cerebrovascular, malignancy) or medication (anabolic steroids, corticosteroids) intake that affect skeletal muscle mass, diabetes mellitus (avoid altered muscle protein metabolism), or use of anticoagulants.\n* abdominal or liver CT scan within 1 year of enrollment for stratification Exclusion\n* Active alcohol consumption within 6 weeks of enrollment\n* Pedal edema (grade 2) above the ankle will be excluded to avoid complications of the muscle biopsy.\n* Liver transplant\n* Active Malignancy\n* Recent GI bleed (4 weeks)\n* Hepatic Encephalopathy within previous 6 months\n* Grade 2 or greater active esophageal varices\n* Active infection\n* Large Ascites as defined by clinical imaging\n* Advanced disease cardiac or pulmonary disease\n* Use of medications affecting muscle protein turnover including corticosteroids or medications used to prevent clotting\n* Clinical lab values that indicate potential poor clotting as determined by the PI\n* Inability to obtain informed consent; judged likely to be unable to perform exercise or unlikely to complete the study in the opinion of the investigators\n* End stage kidney disease as determined by glomerular filtration rate (eGFR) \\\u003C 15 ml\u002Fmin\u002F1.73m2 or dialysis\n* Patients who in the opinion of the PI are unsafe for exercise (failure to pass stress test)","21 Years",{"count":602,"type":22},40,[144],"This study aims to investigate the effects of 12 weeks of resistance or endurance exercise on patients with cirrhosis. Cirrhotic patients are prone to muscle loss (sarcopenia) and ammonia build up due to liver dysfunction. The liver which in healthy patients is able to process ammonia through ureagenesis is unable to do so in cirrhosis and ammonia is taken up either by the brain causing confusion or the skeletal muscle causing muscle loss or sarcopenia. Primary sarcopenia occurs in older individuals and can be mitigated by exercise. Secondary sarcopenia occurs in response to disease such as cancer, chronic kidney disease, multiple sclerosis, and cirrhosis of all etiologies. Resistance exercise is an excellent stimulator for muscle protein synthesis and is widely used to build muscle mass and strength but has little benefit to cardiovascular function. Endurance exercise has shown to be safe in cirrhosis however there is no set prescription for cirrhosis as there is for other disease. Endurance exercise is known to promote improved cardiovascular health, improve fatigue, and generates less ammonia build up than resistance exercise. In patients with low muscle mass it is possible that endurance exercise alone will be enough to improve muscle mass. There have been few studies on exercise and cirrhosis, those that exist have shown benefits with endurance exercise. However there are even more limited studies on resistance exercise and few to no studies on the molecular mechanisms behind exercise in cirrhosis. Study visits are described fully in the protocol and consent form. After passing a screening visit patients will undergo a maximal exercise\u002Ffitness test (pre-baseline test) and other body composition measurements. After the screening and pre-baseline visit randomization will occur (2:2:1 endurance, resistance, or SOC) arrangements will be made to have the appropriate exercise equipment given to patients. Once the exercise equipment has arrived a baseline study visit will occur. After the baseline visit the endurance exercise group will cycle 3 days per week for 60 minutes under the supervision of the study team. The resistance exercise group will perform a whole body resistance workout 2 days per week for approximately 60 minutes under the supervision of a study team member.\n\nPatients in all groups will have the fitness test repeated at weeks 4, 8 and 12. After the 12 weeks of exercise the baseline visits will be repeated and after 2 weeks patients will complete one final fitness test to examine the effects of de-training.",[28],"2025-11-24",{"date":608,"type":37},"2025-11-25",{"date":610,"type":37},"2023-06-01",{"date":612,"type":22},"2027-08-10",{"name":614,"class":44},"The Cleveland Clinic",{"id":616,"slug":617,"hasResults":12,"nctId":618,"briefTitle":619,"officialTitle":619,"acronym":4,"eligibilityCriteria":620,"healthyVolunteers":12,"sex":18,"minAge":600,"maxAge":195,"enrollmentInfo":621,"targetDuration":4,"studyType":23,"phases":623,"briefSummary":624,"conditions":625,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":606,"lastUpdatePostDateStruct":626,"startDateStruct":627,"completionDateStruct":629,"leadSponsor":631,"locationsCount":45},"100452053","hmb-enriched-amino-acids-to-reverse-muscle-loss-in-cirrhosis-100452053","NCT05166499","HMB Enriched Amino Acids to Reverse Muscle Loss in Cirrhosis","Inclusion Criteria:\n\n* Diagnosis of cirrhosis of the liver\n* Child-Pugh score of 5-8\n\nExclusion Criteria:\n\n* Recent gastrointestinal bleeding (\\\u003C3m)\n* Active infection\n* Overt encephalopathy\n* Renal failure on dialysis\n* Pedal edema\n* Uncontrolled diabetes (HbA1C \\> 7.9mg\u002FdL)\n* Advanced cardiac, lung, kidney disease\n* Metastatic cancer\n* Medications that alter muscle protein metabolism\n* Pregnancy\n* Recent bowel resection or gastric bypass surgery,\n* INR \\>1.7, platelets \\\u003C60,000\u002Fml, serum creatinine \\>2mg\u002FdL\n* Medications that interfere with blood clotting",{"count":622,"type":22},24,[144],"Loss of skeletal muscle mass or sarcopenia is the most common and potentially reversible complication in cirrhosis that increases morbidity and mortality before, during and after liver transplantation. No proven treatments exist for the prevention or reversal of sarcopenia in cirrhosis, primarily because the mechanisms responsible for this are unknown. Based on compelling preliminary studies and those of the co investigator, investigators hypothesize that the mechanism of reduced skeletal muscle mass in cirrhosis is due to a myostatin mediated impaired mTOR (mechanistic target of rapamycin) signaling resulting in reduced protein synthesis and increased autophagy. Investigators further postulate that leucine, a direct stimulant of mTOR, will reverse the impaired mTOR phosphorylation in the skeletal muscle of cirrhotics. The consequent increase in protein synthesis reduced autophagy will result in an increase in skeletal muscle mass. Investigators will test these hypotheses by quantifying the response to acute and long term (3 month) administration of hydroxymethyl butyrate (HMB) enriched essential amino acid compared with an isonitrogenous isocaloric non-essential balanced amino acid mixture (does not stimulate protein synthesis) in cirrhotic patients. Fractional protein synthesis rate (FSR) in skeletal muscle, responses of the molecular regulatory pathways of skeletal muscle protein synthesis, and autophagy flux will be quantified in the acute and long term protocols. Tracer studies using L-\\[D5\\]-phenylalanine (Phe) as a primed constant infusion (prime 2µmol.kg-1.hr-1; constant 0.05 µmol.kg-1.hr-1) with and L \\[ring-D2\\] tyrosine, forearm plethysmography, and sequential skeletal muscle biopsies (total of 3 per study subject) will be used to quantify these outcomes. Anthropometric, clinical and body composition measures will be additional outcome measures for the long term intervention. Expression of regulatory signaling proteins, myostatin, IGF-1 (insulin like growth factor) , phospho-Akt, phospho-AMPK (activated protein kinase), phospho-mTOR and phospho-p70s6k will be quantified by Western immunoblots. Autophagy flux will be measured by quantifying expression of the autophagosome proteins.",[28],{"date":608,"type":37},{"date":628,"type":37},"2021-11-30",{"date":630,"type":22},"2026-12-30",{"name":614,"class":44},{"id":633,"slug":634,"hasResults":12,"nctId":635,"briefTitle":636,"officialTitle":637,"acronym":638,"eligibilityCriteria":639,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":640,"targetDuration":4,"studyType":23,"phases":642,"briefSummary":643,"conditions":644,"keywords":649,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":650,"lastUpdatePostDateStruct":651,"startDateStruct":652,"completionDateStruct":654,"leadSponsor":656,"locationsCount":45},"100551068","phase-1-a-study-of-siplizumab-in-aild-and-lt-patients-100551068","NCT06455280","A Study of SIPLIZUMAB in AILD and LT Patients","A 12-Month, Open-Label Study Evaluating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Siplizumab as Induction Therapy in Patients With Autoimmune Liver Diseases Undergoing Liver Transplantation (SET-SAIL)","SET-SAIL","Inclusion Criteria:\n\n1. Able to provide informed consent\n2. Age ≥ 18 years old\n3. Clinical diagnosis of AIH and\u002For PSC\n4. Listed for liver transplantation\n5. Epstein-Barr virus (EBV) seropositive within 12 months of screening\n\nExclusion Criteria:\n\n1. Presence or history of significant liver disease other than AIH or PSC, including viral hepatitis, alcohol-related liver disease and biopsy-proven non-alcoholic steatohepatitis\n2. Prior transplant\n3. Listed for multiorgan transplant\n4. Acute liver failure\n5. Known malignancy, including cholangiocarcinoma and hepatocellular carcinoma\n6. Other investigational products in the last 30 days or 5 half lives\n7. Pregnant\u002Flactating or unwilling to use contraception\n8. Leukopenia (WBC less than 2,000\u002Fmm3\n9. Absolute lymphocyte count \\\u003C 200\u002Fmm3\n10. Sero-positive for HIV-1\n11. Hepatitis C Virus (HCV) antibody or RNA positive (within 6 months of screening)\n12. HBsAg, hepatitis B virus (HBV) DNA or HBcAb positive (within 6 months of screening)\n13. Alcohol use exceeding 30g\u002Fday for men or 20g\u002Fday for women, and\u002For known phosphatidylethanol (PETH) level \\>80 in the 3 months prior to LT\n14. Untreated latent TB infection as detected by QuantiFERON Gold Plus Interferon Gamma Release Assay (IGRA) (or current standard interferon gamma release assay for TB)\n15. Receipt of any live-attenuated vaccine within 2 months of transplant.\n\nADDITIONAL exclusion criteria to be reviewed at the time of transplant\n\n1. Renal failure with dialysis or with estimated glomerular filtration rate (eGFR) \\\u003C 30 at the time of LT\n2. Model for end-stage liver disease (MELD)-Na score \\>30\n3. Donor features of Donation after Cardiac Death (DCD), HCV Ab or nucleic acid testing (NAT+), HBcAb or HBsAg+, or blood types A, B, and O incompatible organ",{"count":641,"type":22},8,[453],"There is a significant unmet need for safe and effective therapeutic approaches to prevent immune-mediated graft injury and its complications in liver transplant (LT) recipients with autoimmune liver disease (AILD) including autoimmune hepatitis and primary sclerosing cholangitis. Siplizumab is an anti-cluster of differentiation 2 (CD2) monoclonal antibody that has demonstrated a favorable safety profile of siplizumab in over 779 human subjects and has been shown to target memory T cells-a key driver in the immune processes surrounding rejection and autoimmunity post LT in AILD. The purpose of this pilot, open-label phase 1 study is to determine the safety of siplizumab for induction in patients with AILD undergoing LT.\n\nUp to eight (8) subjects will receive siplizumab 0.6 mg\u002Fkg\u002Fdose on the day of transplant (Day 0) and Day 4 post-transplant, for a total of two doses.\n\nAll subjects will be followed in the study for 12 months post-LT.",[645,646,647,648,147,28],"Autoimmune Liver Disease","Liver Transplant Disorder","Autoimmune Hepatitis","Primary Sclerosing Cholangitis",[645,646,647,648,147,28],"2025-11-19",{"date":606,"type":37},{"date":653,"type":37},"2024-09-11",{"date":655,"type":22},"2028-03-31",{"name":657,"class":44},"Elizabeth C. Verna",{"id":659,"slug":660,"hasResults":12,"nctId":661,"briefTitle":662,"officialTitle":662,"acronym":663,"eligibilityCriteria":664,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":665,"targetDuration":4,"studyType":23,"phases":666,"briefSummary":667,"conditions":668,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":670,"lastUpdatePostDateStruct":671,"startDateStruct":673,"completionDateStruct":675,"leadSponsor":677,"locationsCount":45},"100583037","phase-1-the-microbiota-augmentation-to-reestablish-commensal-organisms-marco-trial-100583037","NCT06871111","The Microbiota Augmentation to Reestablish Commensal Organisms (MARCO) Trial","MARCO","Inclusion Criteria:\n\n* Age 18 years or older\n* Diagnosis of liver disease, liver failure, and\u002For cirrhosis\n* All patients will be hospitalized and have a hepatology consult in place.\n* They will be identified as having liver disease, liver failure, and\u002For cirrhosis based on a combination of at least one of the following:\n\n  * Labs demonstrating elevated liver chemistries (AST and ALT), elevated serum bilirubin levels, prolonged INR, or radiologic evidence of cirrhosis (e.g. nodular liver contour);\n  * Liver biopsy results; and\u002For\n  * Clinical or radiologic evidence of portal hypertension (e.g. splenomegaly, known varices, ascites, or hepatic venous pressure gradient ≥ 10mmHg).\n  * All diagnoses will be confirmed by the attending hepatologist's interpretation and consult note attestation.\n* Admitted to the hospital for hepatic decompensation\n* MELD score ≤ 30 at time of enrollment\n* Subject has ≤ 700µM butyrate and ≤ 10µM deoxycholate in fecal sample\n\nExclusion Criteria:\n\n* MELD score \\>30 at time of enrollment\n* Patients receiving any antibiotics for treatment of an infection.\n* Chronic or prophylactic antibiotic administration other than rifaximin, ciprofloxacin, or trimethoprim-sulfamethoxazole.\n\n  -Rifaximin will be either temporarily held or switched to another non-antibiotic therapy (e.g. lactulose or sodium benzoate) during the treatment phase of the trial. Potential subjects in whom the treating hepatologist deem it unsafe to pause or switch from Rifaximin therapy during the 7-10 day treatment phase will be excluded from the study.\n* Patients who are currently admitted to the intensive care unit for vasoactive support or mechanical ventilation.\n* Patients meeting the North American Consortia for Study of End Stage Liver Disease (NACSELD) criteria for acute-on-chronic liver failure (ACLF) with ≥ 2 organ failures by NACSELD-ACLF criteria at time of enrollment.\n* Patients with known intestinal barrier dysfunction, including active GI bleeding, enteropathy (including celiac disease), clinically active inflammatory bowel disease (Crohn's or Ulcerative Colitis), ischemic colitis, microscopic colitis, graft versus host disease (GVHD), or gastrointestinal malignancy.\n\n  o Active inflammatory bowel disease (IBD) will be defined based on a combination of:\n  * Symptoms (diarrhea and\u002For abdominal pain without another explanation)\n  * Laboratory evidence of inflammation (e.g. elevated CRP or fecal calprotectin without another explanation); and\n  * Either radiologic, endoscopic, and\u002For histologic evidence of active IBD.\n  * If IBD is suspected, this will be investigated with the general GI consult service prior to approaching for enrollment.\n  * If patients carry a diagnosis of IBD but do not meet the above criteria, they will be eligible for enrollment unless their IBD is managed with a systemic immunosuppression medication (e.g. anti-TNF-alpha therapy).\n  * If any form of the above intestinal disorders is suspected, they will be investigated with the general GI consult service prior to approaching for enrollment.\n* Profoundly immunocompromised patients, including patients with primary immunodeficiency, solid organ transplant recipients, any history of hematopoietic stem cell transplant (HSCT), ongoing cancer treatment, neutropenia \\\u003C 500 cells\u002Fmm3, HIV untreated or with CD4 \\\u003C 200 cells\u002Fmm3, immunosuppressive medications, including rituximab, anti-cytokine therapy, anti-rejection medications, chronic corticosteroids (a dose ≥ 20mg of prednisone daily for ≥ 1 month), biologic therapy for autoimmune condition.\n* Patients with delayed gastrointestinal motility as evidenced by ≤ 2 bowel movements per week at the time of enrollment.\n* Patients who are allergic to both ampicillin\u002Fsulbactam and meropenem.\n\n  * These are the two empiric antibiotic therapies that every strain is susceptible to.\n  * If a patient is allergic to only one of these medications, they may still be approached for enrollment.\n* A history of allergy to any of the investigational products\u002Fcomponents.\n* Patients with liver disease from Hepatitis C.\n* Patients with existing inflammatory arthritis.\n* History of total colectomy.\n* Patients who do not intend to continue their care on a routine basis at the University of Chicago beyond 6 months from the time of enrollment.\n* Patients with untreated psychiatric conditions, including illicit substance use disorders, that may interfere with reliable follow-up.\n* Unable to participate based on medical judgement of the care team.\n* Special populations:\n\n  * Women of childbearing age will have a:\n\n    * Negative serum pregnancy test at screening\n    * Use a medically acceptable and highly effective method of birth control for at least 6 weeks following completion of treatment.\n  * Another investigational drug or LBP:\n\n    * Prior use will be permitted;\n    * Concurrent use will preclude enrollment;\n    * Use will be restricted for the duration of the study (12 months after commensal consortia completion)\n  * Patients who are prescribed ACE-inhibitors and receive a consortium containing C. comes will receive more frequent blood pressure monitoring.\n  * Patients who are prescribed metformin will require either:\n\n    * Switch to another medication for diabetes control; or\n    * More frequent Vitamin B12 monitoring at 1, 3, 6, and 12 months of enrollment.\n* If a Vitamin B12 deficiency is discovered, it will be repleted as clinically indicated.",{"count":622,"type":22},[453],"The Microbiota Augmentation to Reestablish Commensal Organisms (MARCO) trial is a single center prospective adaptive phase 1b clinical trial in patients who are hospitalized with complications of liver disease and have low fecal metabolite levels (butyrate and deoxycholic acid). The study intervention is 1 of 9 novel live Commensal Consortia each containing eight commensal bacterial strains derived from healthy donors. The primary objective of the study is to determine safety and tolerability of Commensal Consortia administration.",[458,669,28],"Liver Failure","2025-11-03",{"date":672,"type":37},"2025-11-04",{"date":674,"type":37},"2025-08-04",{"date":676,"type":22},"2028-02-04",{"name":187,"class":44}]