[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"liver-failure\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:liver-failure":510},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,21,0,[8,42,66,95,115,135,162,183,209,231,269,293,315,341,363,384,407,424,445,467,488],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100643386",false,"NCT07634562","TLI- and ATG-Enabled Minimization Protocol in Liver Transplantation","A Phase 1-2 Prospective Study to Evaluate the Safety and Feasibility of Total Lymphoid Irradiation (TLI) and Anti-Thymocyte Globulin (ATG) in Liver Transplantation Recipients to Induce Immune Tolerance","TEMPO-LT","Inclusion Criteria:\n\n* Undergoing liver transplantation at Stanford University\n* No contraindications to Total Lymphoid Irradiation or rabbit antithymocyte globulin (rATG)\n\nExclusion Criteria:\n\n* Contraindications to Total Lymphoid Irradiation (e.g. pregnancy, bone marrow suppression or disease, autoimmune disease, prior radiation in the field)\n* Contraindications to rATG\n* Patients with history of hepatocellular carcinoma (HCC) or other malignancies with exception of non melanoma skin cancer in remission Model of End-Stage Liver Disease (MELD) score \\> 25 Liver transplants with severe reperfusion syndrome (hemodynamic instability requiring 3 or more pressors after reperfusion) Liver transplant with early allograft dysfunction (Orloff criteria) Diagnosis of hepatitis B Diagnosis of hepatitis C, except for patients that have been treated and eradicated of hepatitis C Virtual and\u002For flow crossmatch positive (MFI added up to 8000 for each DSA with MFI\\>1000).\n\nSubject has previously received or is receiving another organ for transplant other than liver Subject is currently on dialysis Recipient or donor is HIV positive Subject has received an ABO incompatible donor Subject has received a donor liver greater than 65 years of age Subject has an active infection at the time of transplant Subject will require immunosuppressive agent other than those prescribed in this study Subject is pregnant or lactating Subject is unlikely to comply with the visits scheduled in the protocol, including protocol biopsies Subject has any form of current substance use, psychiatric disorder or condition that may invalidate communication with the Investigators","ALL","18 Years","55 Years",{"count":20,"type":21},12,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","The unmet medical need in solid organ transplantation is to eliminate the lifelong requirement of powerful immune suppression drug combinations with their attendant side effects, and to prevent immune mediated rejection of the organ transplant. The proposed trial is designed to study if following a 'standard of care' deceased donor liver transplant host conditioning using Total Lymphoid Irradiation (TLI) and Anti-Tthymocyte Globulin (ATG) will result in operational tolerance and ultimately allow for immunosuppression drug minimization or cessation.\n\nIt has been hypothesized that the ATG and TLI conditioning regimen post liver transplant will be safe and well tolerated and will result in recipients successfully being withdrawn from immunosuppression within 2 years after liver transplantation. We will test the hypothesis that by using a conditioning regimen of ATG and TLI to induce this operational tolerance will allow immunosuppressive drug minimization and cessation while maintaining normal graft function and without the risk of graft rejection.\n\nImportance of this knowledge:\n\nOperational tolerance occurs spontaneously in a minority of liver transplant recipients; however, predictable and reproducible induction of tolerance remains an unmet need. Building on extensive experience with TLI-based tolerance induction in kidney transplantation at Stanford, this study aims to evaluate whether a non-myeloablative conditioning regimen using TLI and ATG can safely facilitate immunosuppression minimization and withdrawal in liver transplant recipients without the use of donor hematopoietic cell infusion.",[28],"Liver Failure","NOT_YET_RECRUITING","2026-06-04",{"date":32,"type":33},"2026-06-09","ACTUAL",{"date":35,"type":21},"2026-08",{"date":37,"type":21},"2031-08",{"name":39,"class":40},"Stanford University","OTHER",1,{"id":43,"slug":4,"hasResults":10,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":65},"100409902","NCT04617522","Study of Sacituzumab Govitecan in Participants With Advanced or Metastatic Solid Tumor and Moderate Liver Impairment","A Phase 1, Open-Label, Dose-Escalation Study to Determine an Appropriate Starting Dose of Sacituzumab Govitecan in Subjects With Advanced or Metastatic Solid Tumor and Moderate Liver Impairment","Key Inclusion Criteria for all Individuals:\n\n* Histologically confirmed advanced or metastatic solid tumor that is measurable or nonmeasurable.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.\n* Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation (hemoglobin ≥ 9 g\u002FdL, absolute neutrophil count (ANC) ≥1,500\u002Fmm\\^3, and platelets ≥ 100,000\u002F μL).\n* Creatinine clearance ≥ 30 mL\u002Fmin as assessed by the Cockcroft-Gault equation.\n\nKey Inclusion Criteria for Individuals with Normal Hepatic Function:\n\n* Normal hepatic function (total bilirubin ≤ ULN and aspartate aminotransferase (AST) ≤ 3.0× ULN).\n\nKey Inclusion Criteria for Individuals with Moderate Hepatic Function:\n\n* Moderate hepatic impairment (1.5 × ULN \\\u003C total bilirubin ≤ 3.0 × ULN and any level of AST).\n* For individuals with hepatic encephalopathy, the condition does not, in the Investigator's opinion, interfere with the individual's ability to provide an appropriate informed consent.\n\nKey Exclusion Criteria for all Individuals:\n\n* Have poor venous access.\n* Donated or lost 500mL or more of blood volume (including plasmapheresis) to plans to donate during the study.\n* Have had a prior anticancer biologic agent within 4 weeks prior to Day 1 or have had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to Day 1 and who have not recovered (i.e., ≤ Grade 1) from adverse events (AEs) at the time of study entry. Individuals participating in observational studies are eligible.\n* Had prior treatment with irinotecan within 4 weeks prior to Day 1.\n* Have not recovered (i.e., ≤ Grade 1) from AEs due to a previously administered agent.\n* Have an active second malignancy.\n* Have known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Individuals with previously treated brain metastases may participate provided they have stable CNS disease for at least 4 weeks prior to the first dose of study drug and all neurologic symptoms have returned to baseline, have no evidence of new or enlarging brain metastases, and are taking \\\u003C 20 mg\u002Fday of prednisone or its equivalent. All individuals with carcinomatous meningitis are excluded regardless of clinical stability.\n* Have history of cardiac disease.\n* Have active chronic inflammatory bowel disease (ulcerative colitis or Crohn's disease) or gastrointestinal (GI) perforation within 6 months of enrollment.\n* Have active serious infection (Contact medical monitor for clarification).\n* High-dose systemic corticosteroids (≥20 mg of prednisone or its equivalent) are not allowed within 2 weeks of Check-In. However, inhaled, intranasal, intra-articular, and topical steroids are allowed.\n* Use of strong inhibitor or inducer of UGT1A1.\n* Have a known history of Gilbert's disease.\n\nKey Exclusion Criteria for Individuals with Normal Hepatic Impairment:\n\n* Must have pre-existing condition interfering with hepatic and\u002For renal function that could interfere with the metabolism and\u002For excretion of the study drug.\n\nKey Exclusion Criteria for Individuals with Moderate Hepatic Impairment:\n\n* Had a significant clinical exacerbation of liver disease symptoms within the 2-week period before administration of study drug (i.e., abdominal pain, nausea, vomiting, anorexia, or fever).\n* Had clinically demonstrable, tense ascites.\n* Had evidence of acute viral hepatitis within 1 month prior to administration of study drug.\n* Have evidence of hepatorenal syndrome.\n* Individuals with transjugular intrahepatic portosystemic shunt (TIPS) placement.\n* Have active Stage 3 or 4 encephalopathy.",{"count":49,"type":21},30,[24],"The goals of this clinical study are to learn more about the safety and dosing of the study drug, sacituzumab govitecan-hziy, in participants with solid tumors and moderate liver problems.",[53,28],"Advanced or Metastatic Solid Tumor","RECRUITING","2026-06-01",{"date":57,"type":33},"2026-06-02",{"date":59,"type":33},"2021-04-06",{"date":61,"type":21},"2026-12",{"name":63,"class":64},"Gilead Sciences","INDUSTRY",15,{"id":67,"slug":4,"hasResults":10,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":22,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":41},"100638137","NCT07595627","Hypothermic Machine Perfusion for Liver Graft Preservation","Prospective and Randomized Clinical Study of the Effect of Hypothermic Machine Perfusion on Liver Graft Preservation","HOPE-Liver","Donor-related inclusion criteria:\n\n* Liver donors with confirmed diagnosis of brain death.\n* Extended criteria donors (ECD).\n* Age ≥18 years.\n* Family consent for organ donation obtained.\n* Negative serology for HTLV, HIV, Chagas disease, and hepatitis B and C.\n\nRecipient-related inclusion criteria:\n\n* Adult patients (≥18 years) undergoing liver transplantation.\n* Diagnosis of end-stage liver disease or indication for liver transplantation.\n* Candidates for primary liver transplantation.\n* Ability to understand and provide written informed consen\n\nDonor-related exclusion criteria:\n\n* Presence of moderate or severe hepatic steatosis.\n* Pediatric donors.\n* Donors classified as ideal, defined by the simultaneous presence of all of the following criteria: Age \\\u003C35 years, Body mass index (BMI) \\\u003C28 kg\u002Fm², No history of cardiopulmonary resuscitation, Norepinephrine requirement \\\u003C0.5 µg\u002Fkg\u002Fmin, Liver enzymes (AST or ALT) ≥2 times the upper limit of normal, Intensive care unit stay ≤7 days\n\nRecipient-related exclusion criteria:\n\n* Complex portal vein thrombosis (grade III or IV).\n* Combined or dual organ transplantation.\n* Retransplantation.\n* Acute liver failure.\n* MELD score \\>30.\n* History of multiple prior liver or biliary surgeries.",{"count":74,"type":21},40,[76],"NA","The goal of this clinical trial is to evaluate whether hypothermic machine perfusion improves liver graft preservation and post-transplant outcomes compared to conventional static cold storage in adult patients undergoing liver transplantation. This study focuses on liver grafts from deceased donors, including those with extended criteria, which are more susceptible to ischemia-reperfusion injury and early graft dysfunction.\n\nThe main questions it aims to answer are:\n\nDoes hypothermic machine perfusion reduce ischemia-reperfusion injury and improve early graft function after liver transplantation? Does this preservation strategy improve clinical outcomes, including graft survival, complication rates, and post-transplant recovery, compared to static cold storage?\n\nResearchers will compare hypothermic machine perfusion (ex situ, oxygenated perfusion at low temperature) to standard static cold storage to assess differences in graft preservation quality and post-transplant outcomes.\n\nParticipants will:\n\nReceive a liver graft preserved either by hypothermic machine perfusion or static cold storage, according to a 1:1 randomization protocol Undergo standard liver transplantation procedures Be followed after transplantation with clinical, laboratory, imaging, and biomarker assessments at predefined time points (7 days, 30 days, 6 months, and 1 year)\n\nAdditional evaluations will include biochemical markers of liver function, inflammatory and immunological mediators, mitochondrial function assessment, and histological analysis to better characterize graft injury and recovery.",[79,28],"Liver Transplant",[81,82,83,84,85],"Hypothermic Machine Perfusion","Liver Transplantation","Ischemia-Reperfusion Injury","Ex Vivo Liver Perfusion","Extended Criteria Donors","2026-05-14",{"date":88,"type":33},"2026-05-19",{"date":90,"type":21},"2026-05-07",{"date":92,"type":21},"2028-05-07",{"name":94,"class":40},"University of Sao Paulo General Hospital",{"id":96,"slug":4,"hasResults":10,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":10,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":22,"phases":102,"briefSummary":103,"conditions":104,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":41},"100616995","NCT07312864","Safety and Tolerability Study of a Novel Bioartificial Liver in Liver Failure and Small-for-Size Syndrome","A Clinical Trial Assessing the Safety, Tolerability, and Exploratory Efficacy of a Novel Bioartificial Liver Therapy in Patients With Liver Failure or Small-for-Size Syndrome","Inclusion Criteria:\n\n* Patients diagnosed with liver failure (including acute, subacute\u002Facute-on-chronic, and chronic liver failure) or small-for-size syndrome\n\nExclusion Criteria:\n\n* Presence of severe extrahepatic systemic end-stage diseases\n* Uncontrollable infection or active bleeding\n* Pregnant or breastfeeding women\n* History of allergy or known severe hypersensitivity to CiPSC-derived cell products or blood products\n* Peripheral vascular collapse leading to inability to obtain venous access or collect blood\n* Unable or unwilling to provide informed consent or unable to comply with study requirements\n* Unwilling to receive CiPSC-based therapy",{"count":20,"type":21},[24,25],"The goal of this clinical trial is to evaluate the safety and tolerability of a novel bioartificial liver (CiPS-BAL) in patients with liver failure or small-for-size syndrome. The study will also collect preliminary data on clinical outcomes and laboratory parameters during treatment. The main questions it aims to answer are:\n\nIs the novel bioartificial liver system safe and well tolerated in patients with liver failure or small-for-size syndrome?\n\nWhat effects does the treatment have on liver function and other clinical and laboratory indicators?\n\nResearchers will treat participants with the CiPS-BAL system, which uses hepatocytes derived from chemically induced pluripotent stem cells (CiPS) within a bioartificial liver device.",[28,105],"Small-for-Size Syndrome","2026-04-15",{"date":108,"type":33},"2026-04-20",{"date":110,"type":33},"2025-12-01",{"date":112,"type":21},"2028-12-31",{"name":114,"class":40},"Beijing Friendship Hospital",{"id":116,"slug":4,"hasResults":10,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":121,"enrollmentInfo":122,"targetDuration":4,"studyType":22,"phases":124,"briefSummary":125,"conditions":126,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":41},"100585622","NCT06904755","Safety and Effectiveness of Mesenchymal Stem Cells in Blood Purification for the Treatment of Liver Failure","Clinical Study on Safety and Effectiveness of Mesenchymal Stem Cells in Blood Purification for the Treatment of Liver Failure","Inclusion Criteria:\n\n1. Age range from 18 to 65 years old;\n2. Patients with acute liver failure in the early and intermediate stages caused by various reasons;\n3. Total bilirubin (TBil) ≥ 171μmol\u002FL or an increase of ≥ 17.1μmol\u002FL per day;\n4. Prothrombin activity (PTA) between 20% and 40% (or INR between 1.5 and 2.6);\n5. No hepatic encephalopathy or encephalopathy below grade II (including grade II);\n6. Elevated inflammatory markers (IL-6 \u002F TNF-α \u002F CRP, etc.);\n7. The subjects are able to communicate well with the researchers and can complete the study in accordance with the study regulations;\n8. The subjects must be informed of this study and voluntarily sign a written informed consent form before the experiment.\n\nExclusion Criteria:\n\n1. Patients with severe active bleeding or diffuse intravascular coagulation;\n2. Patients with a high degree of allergy to blood products or drugs used during treatment, such as plasma, heparin, and protamine;\n3. Patients with circulatory failure;\n4. Patients with a MELD score \\> 30;\n5. Patients with other severe heart diseases, lung diseases, blood diseases, autoimmune diseases, or diabetes;\n6. Subjects who may be unable to complete this study for other reasons or who the researchers believe should not be included.","65 Years",{"count":123,"type":21},10,[24],"The goal of this clinical trial is to learn if mesenchymal stem cells in blood purification works to treat liver failure in adults. It will also learn about the safety and effectiveness of mesenchymal stem cells in blood purification. The main questions it aims to answer are:1.Does mesenchymal stem cells in blood purification improve the condition of patients with liver failure? 2.What medical problems do participants have when taking mesenchymal stem cells in blood purification? Participants will receive routine medical treatment and blood purification treatment with mesenchymal stem cells.These cells work outside the body and do not enter the body. We will: 1.Collect samples from participants such as blood, Urine and feces. 2.record post-treatment outcomes such as survival rate at 4 weeks after treatment, conversion rate to liver transplantation, Inflammatory, survival rate at 7days, 14days, 8 weeks and 12 weeks after treatment, and liver disease indicators(prothrombin time activity percentage, lactic aicd, blood ammonia, α-fetoprotein, ferritin).",[28],"2026-04-11",{"date":106,"type":33},{"date":130,"type":33},"2024-04-23",{"date":132,"type":21},"2026-12-30",{"name":134,"class":40},"Kebo Zhong",{"id":136,"slug":4,"hasResults":10,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":10,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":144,"phases":4,"briefSummary":145,"conditions":146,"keywords":147,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":161},"100544220","NCT06366048","A Study on Relationship Between Resected Normal Liver Parenchymal Volume（RNLV）and Post-Hepatectomy Liver Failure (PHLF)","A Model Based on Resected Normal Liver Parenchymal Volume（RNLV）to Predict the Risk of Post-Hepatectomy Liver Failure (PHLF)","RNLV","Inclusion criteria:\n\n* selective hepatectomies;\n* histologically confirmed as HCC and ICC\n* complete and accessible data\n\nExclusion criteria:\n\n* any history of Associated Liver Partition and Portal vein ligation for Staged hepatectomy (ALPPS)\n* any history of portal vein embolism (PVE)\n* any history of tumor rupture\n* emergency surgery\n* pathologically diagnosed with neither HCC nor ICC\n* concomitant resection of gastrointestinal organs, spleenectomy or other organs",{"count":143,"type":21},1600,"OBSERVATIONAL","The post-hepatotectomy liver failure (PHLF) is still the most worrisome complication of hepatic resection. Surgeons have always been making efforts to preoperatively predict PHLF using kinds of techniques, scoring systems, and variables. The investigators of this study tried to create an individual predictive model based on the variable, resected normal parenchymal volume (RNLV), then assessing the performance and value of the model in clinical practice.",[28],[148,149,150],"resected normal parenchymal volume (RNLV)","postoperative hepatectomy liver failure (PHLF)","future liver remnant (FLR)","2026-04-09",{"date":153,"type":33},"2026-04-14",{"date":155,"type":33},"2022-12-01",{"date":157,"type":21},"2026-12-31",{"name":159,"class":160},"National Natural Science Foundation of China","OTHER_GOV",3,{"id":163,"slug":4,"hasResults":10,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":22,"phases":171,"briefSummary":172,"conditions":173,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":181,"locationsCount":41},"100495042","NCT05726032","Empagliflozin in Patients With Cirrhosis and Ascites","Effects of Empagliflozin on Natriuresis and Volume Overload in Patients With Cirrhosis and Ascites","EMPA Liver","Inclusion Criteria:\n\n1. Patients with cirrhosis and ascites on a stable dose of diuretics (spironolactone +\u002F- loop-diuretics based on AASLD guidelines)10 and who do not require large volume paracenteses\n2. eGFR \\>= 30mL\u002Fmin\u002F1.73 m2\n3. \\>=18 years old\n\nExclusion Criteria:\n\n1. Hospitalization due to a complication of cirrhosis in the previous 8 weeks (e.g. variceal hemorrhage, encephalopathy, acute kidney injury, spontaneous bacterial peritonitis)\n2. Direct bilirubin \\>=3 mg\u002FdL\n3. Systolic blood pressure \\\u003C 100 mmHg\n4. Active malignancy including hepatocellular carcinoma undergoing treatment\n5. History of bladder dysfunction, incontinence, pyelonephritis, urosepsis, or frequent urinary tract infections\n6. Use of SGLT-2 inhibitors in the last 10 days, or previous use with intolerance\n7. Type 1 diabetes\n8. History of frequent hypoglycemic episodes\n9. Use of a non-loop diuretic aside from aldosterone antagonists or amiloride as they are not standard of care in patients with cirrhosis and could potentially increase the risk of hypovolemia when combined with the standard treatment for ascites along with SGLT2 inhibitor.\n10. Hepatic hydrothorax requiring thoracentesis in the prior 8 weeks\n11. Hepatic encephalopathy grade II or greater at the time of enrollment\n12. Patients who have had TIPS placed\n13. Previous liver transplant\n14. Participation in another trial with an investigational drug within the 30 days prior to informed consent\n15. Pregnancy or breastfeeding\n16. Inability to give written informed consent or follow study protocol (e.g. clinically-significant psychiatric, addictive, or neurological disease)\n17. Change in diuretic dose in the prior 2 weeks\n18. Patients with hospitalization for alcoholic hepatitis in the past 6 months\n19. Significant worsening of creatinine (more than 50% increase) in the past 4 weeks\n20. MELD-Na \\> or equal to 20\n21. Hemoglobin \\\u003C8",{"count":170,"type":21},20,[25],"A proof-of-concept placebo-controlled trial to explore the acute and 14-day effects of empagliflozin on natriuresis and total body water in patients with cirrhosis and ascites. We will additionally investigate its effect on neurohumoral activation, and renal hemodynamics.",[174,28],"Cirrhosis","2026-02-17",{"date":177,"type":33},"2026-02-19",{"date":179,"type":33},"2023-09-11",{"date":55,"type":21},{"name":182,"class":40},"Yale University",{"id":184,"slug":4,"hasResults":10,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":188,"eligibilityCriteria":189,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":190,"targetDuration":4,"studyType":22,"phases":192,"briefSummary":194,"conditions":195,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":208},"100396884","NCT04447911","Effects of the SGLT2 Inhibitor Empagliflozin in Patients With Euvolemic and Hypervolemic Hyponatremia","Effects of the SGLT2 Inhibitor Empagliflozin in Patients With Euvolemic and Hypervolemic Hyponatremia - a Multicentric Randomized Double-blind Placebo-controlled Trial (the EMPOWER Study)","EMPOWER","Inclusion Criteria:\n\n\\- chronic eu- OR hypervolemic non hyperosmolar (\\\u003C300 mOsm\u002Fkg) hyponatremia (heparin plasma sodium \\\u003C135 mmol\u002FL on day of inclusion)\n\nExclusion Criteria:\n\n* known hypersensitivity or allergy to class of drugs or the investigational product,\n* severe symptomatic hyponatremia in need of treatment with 3% NaCl-solution or in need of intensive\u002Fintermediate care treatment at time of inclusion\n* clinical hypovolemia\n* Severe reduction of eGFR \\\u003C20 mL\u002Fmin\u002F1,73 m2 (KDIGO G4 and G5) or end stage renal disease\n* Chronic liver insufficiency with Child Pugh Score ≥10 or decompensated liver cirrhosis (jaundice, hepatorenal syndrome, encephalopathy, bleeding, …)\n* Hepatic impairment defined as aspartate transaminase (AST) or alanine transaminase (ALT) \\>3x the upper limit of normal (ULN); or total bilirubin \\>2x ULN at time of enrolment\n* uncontrolled hypothyroidism\n* uncontrolled adrenal insufficiency\n* systolic blood pressure \\\u003C90mmHg\n* contraindication for lowering blood pressure\n* diabetes mellitus type 1 or pancreatic diabetes mellitus\n* treatment with SGLT2 inhibitors, lithium chloride, vaptans, demeclocycline or urea on inclusion day\n* severe immunosuppression (leucocytes \\\u003C2 G\u002Fl)\n* peripheral arterial disease stage III-IV of the Fontaine Classification\n* fasting or other reasons preventing medication intake\n* previous enrolment into the current study\n* participation in another intervention study\n* pregnancy, breastfeeding, intention to become pregnant during the course of the study or lack of safe contraception.\n* end of life care",{"count":191,"type":21},172,[193],"PHASE4","Hyponatremia is the most common electrolyte derangement occurring in hospitalized patients. It is usually classified as hypovolemic, euvolemic or hypervolemic. The most common aetiology of euvolemic hyponatremia is the syndrome of inappropriate antidiuresis (SIAD). Hypervolemic hyponatremia is common in patients with congestive heart failure (CHF) (10-27%) and liver cirrhosis (up to approximately 50%). In SIAD, the regulation of arginine vasopressin (AVP) secretion is impaired which leads to free water retention. In CHF and liver cirrhosis, the effective arterial blood volume is decreased leading to non-osmotic baroreceptor mediated AVP release and consecutive free water retention.\n\nCurrent treatments of euvolemic and hypervolemic hyponatremia, including the most used treatment fluid restriction, are of limited efficacy. Sodium-Glucose-Co-Transporter 2 (SGLT2) inhibitors reduce glucose reabsorption in the proximal tubule, resulting in glucosuria and consecutive osmotic diuresis. A placebo-controlled randomized trial of our group has shown that a short-term, i.e. a 4-days administration of the SGLT2 inhibitor empagliflozin (Jardiance)® in addition to fluid restriction was effective in increasing the serum sodium concentration in 87 patients with SIAD-induced hyponatremia. The effect of empagliflozin (Jardiance)® without additional fluid restriction is however not yet known. Large randomized controlled trials have shown that SGLT2 inhibitors reduced hospitalization for heart failure in patients with, and more recently without type 2 diabetes. No studies have investigated the effect of SGLT2 inhibitors in hypervolemic hyponatremia.\n\nTo evaluate the effect of empagliflozin (Jardiance)® in eu- and hypervolemic hyponatremia, a randomized placebo-controlled study is needed.",[196,197,28,198],"Hyponatremia","SIADH","Kidney Failure","2025-11-14",{"date":201,"type":33},"2025-11-17",{"date":203,"type":33},"2021-02-04",{"date":205,"type":21},"2027-02",{"name":207,"class":40},"University Hospital, Basel, Switzerland",6,{"id":210,"slug":4,"hasResults":10,"nctId":211,"briefTitle":212,"officialTitle":212,"acronym":213,"eligibilityCriteria":214,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":215,"targetDuration":4,"studyType":22,"phases":217,"briefSummary":218,"conditions":219,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":41},"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":216,"type":21},24,[24],"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.",[220,28,221],"Liver Diseases","Cirrhosis, Liver","2025-11-03",{"date":224,"type":33},"2025-11-04",{"date":226,"type":33},"2025-08-04",{"date":228,"type":21},"2028-02-04",{"name":230,"class":40},"University of Chicago",{"id":232,"slug":4,"hasResults":10,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":10,"sex":16,"minAge":237,"maxAge":238,"enrollmentInfo":239,"targetDuration":4,"studyType":22,"phases":241,"briefSummary":242,"conditions":243,"keywords":249,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":41},"100597053","NCT07053488","CRISPR-Edited HLA Donor Liver Transplant to Reduce Rejection","A Phase 1\u002F2, Open-Label, Single-Arm Study to Evaluate the Safety, Immunogenicity Reduction, Transplant Function, and Feasibility of Ex Vivo CRISPR-Cas9 Gene-Edited Donor Liver Transplantation Targeting HLA Class I (HLA-A, HLA-B) and Class II (Via CIITA) Genes.","Inclusion Criteria:\n\n* Adults aged 16-85 (inclusive) with end-stage liver disease or acute liver failure who are eligible for liver transplantation.\n* Require a liver transplant and have been allocated a donor liver graft (from a deceased donor) that will be used in the study after gene editing.\n* No immediately available fully HLA-matched donor (since the study targets patients who would otherwise receive an HLA-mismatched organ; standard allocation generally does not consider HLA matching for liver, so most patients will qualify).\n* Medically suitable for transplant surgery and able to tolerate standard immunosuppressive therapy (no contraindications to transplant such as uncontrolled infection or other active serious disease that would preclude surgery).\n* Informed Consent: Able to understand the investigational nature of the trial and provide written informed consent. Patients (and their legal representatives if applicable) must consent to the use of a genetically modified organ and to long-term follow-up including multiple biopsies and immune monitoring.\n* Willingness to comply with all study procedures and availability for the duration of follow-up (including frequent monitoring visits).\n\nExclusion Criteria:\n\n* Active uncontrolled infection (e.g., sepsis, active tuberculosis) that would severely increase transplant risk or confound interpretation of immune-related outcomes.\n* Uncontrolled HIV or chronic viral infections that are not well-managed. (Note: Patients with hepatitis B or C may be included if adequately treated or under control, as these are common in liver failure, but such patients should not have active, replicating virus at transplant if possible.)\n* Multi-organ transplant requirement: Patients needing more than a liver alone (e.g., liver-kidney dual transplant) are excluded, as the trial is only evaluating single organ (liver) outcomes.\n* Pregnancy or breastfeeding: Female participants of childbearing potential must have a negative pregnancy test prior to transplant and must agree to use effective contraception. The effects of a gene-edited organ transplant on a fetus\u002Finfant are unknown, and immunosuppressive drugs can also harm a pregnancy.\n* Severe concurrent illness not related to liver disease that would limit survival to \\\u003C1 year or make the patient an unsuitable candidate (e.g., advanced heart failure, uncontrolled diabetes with complications, etc.).\n* Allergy or hypersensitivity to study-related products: If any components used in the ex vivo gene editing (such as a specific vehicle or enzyme) have known severe allergies in the recipient, they will be excluded. (For instance, although unlikely, if a patient had a documented severe immune reaction to Streptococcus pyogenes Cas9 or similar proteins, they would not be enrolled.)\n* Inability to follow the protocol or comply with follow-up: this includes psychiatric, social or logistical factors that would prevent adhering to the intense monitoring schedule (for example, lack of reliable transportation or support).","16 Years","85 Years",{"count":240,"type":21},90,[24,25],"This early-phase clinical trial will assess the use of ex vivo CRISPR-Cas9 genome editing on donor liver grafts to reduce immunogenicity before transplantation. Donor livers will have HLA-A and HLA-B genes knocked out, and HLA class II expression disabled (by targeting the CIITA transactivator gene), aiming to create a \"hypoimmunogenic\" organ less prone to rejection. The edited liver is then transplanted into patients with end-stage liver disease. The primary focus is on safety and feasibility - determining whether a CRISPR-edited liver can be transplanted successfully and function normally - as well as evaluating reductions in immune response (acute rejection, anti-donor T cell activation) and graft function over time.",[220,244,245,28,246,247,248],"Liver Cancer","Liver Cirrhosis","Liver Metastases","Liver Transplant Rejection","Liver Steatoses",[250,251,252,253,79,254,255,256,257,258,259],"End-Stage Liver Disease requiring transplantation","Prevention of Allograft Rejection in Liver Transplantation","CRISPR-Cas9","Gene Editing","Organ Transplantation","Immunogenicity Reduction","HLA Knockout","Hypoimmunogenic Graft","Allograft Rejection","Universal Donor Organ","2025-06-26",{"date":262,"type":33},"2025-07-08",{"date":264,"type":33},"2025-06-01",{"date":266,"type":21},"2028-12-28",{"name":268,"class":40},"AMERICAN ORGAN TRANSPLANT AND CANCER RESEARCH INSTITUTE LLC",{"id":270,"slug":4,"hasResults":10,"nctId":271,"briefTitle":272,"officialTitle":272,"acronym":273,"eligibilityCriteria":274,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":275,"targetDuration":4,"studyType":144,"phases":4,"briefSummary":277,"conditions":278,"keywords":280,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":285,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":41},"100585928","NCT06908746","Efficacy and Safety of Citrate Anticoagulation in CRRT for Patients With Liver Failure\u002FDysfuncTION, the CAUTION Trial! A Retrospective Study on Etiology of Liver Failure and Their Complications","Caution","Inclusion Criteria:\n\n* Critically ill patients diagnosed with AKI requiring CRRT. Caution Protocol V1.0 24-07-2024\n* Documented liver failure or significant liver dysfunction (e.g., elevated liver enzymes, bilirubin levels, or clinical diagnosis of liver failure) and clincal diagnosis of shock (NE of 0.25 μg\u002Fkg\u002Fmin and or association of second vasopressor).\n* Age ≥ 18 years.\n\nExclusion Criteria:\n\n* NA",{"count":276,"type":21},100,"Study design A retrospective cohort study will be conducted to compare the efficacy and safety of citrate anticoagulation in CRRT among patients with liver failure\u002Fdysfunction and severe shock.\n\nObjectives\n\n1. Primary Objective: To determine if the etiology of liver failure impacts the incidence of citrate-related complications in patients undergoing CRRT.\n2. Secondary Objectives: To compare the efficacy of citrate anticoagulation in terms of renal recovery, filter lifespan, and patient survival between those with liver failure\u002Fdysfunction and severe shock.",[28,279],"AKI - Acute Kidney Injury",[281,282,283],"CRRT","liver failure","AKI","2025-04-02",{"date":286,"type":33},"2025-04-03",{"date":288,"type":33},"2024-09-30",{"date":290,"type":21},"2025-12-31",{"name":292,"class":40},"University Hospital, Antwerp",{"id":294,"slug":4,"hasResults":10,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":4,"eligibilityCriteria":298,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":121,"enrollmentInfo":299,"targetDuration":4,"studyType":22,"phases":301,"briefSummary":302,"conditions":303,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":307,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":41},"100515319","NCT05989958","The Safety ,Tolerability and Efficacy Study of HepaCure in Chinese Subjects with Acute-On-Chronic Liver Failure","A Multicenter, Randomized, Controlled, Open-Label Phase 1\u002F2 Clinical Study to Evaluate the Safety, Tolerability and Efficacy of HepaCure Plus DPMAS Versus DPMAS Alone in Chinese Subjects with Acute-On-Chronic Liver Failure","Inclusion Criteria:\n\n1. Able to communicate effectively with investigators and sign the informed consent form (ICF) voluntarily.\n2. Age: ≥ 18 years and ≤ 65 years.\n3. Body weight: ≥ 40kg;\n4. Met the criteria of ACLF in the early and middle stages in screening period (Guidelines for the Diagnosis and Treatment of Liverfilture (2018 Edition)): base on chronic liver disease, acute jaundice deepened and coagulation dysfunction caused by various inducements, manifested as extreme fatigue, with obvious gastrointestinal symptoms such as anorexia, vomiting, abdominal distention, etc; Progressive deepening of jaundice, serum TBil ≥ 171 μmol\u002FL or increase ≥ 17.1 μmol\u002FL daily or ≥10 × upper limit of normal value; with bleeding tendencies or manifestations (bleeding spots or ecchymosis), or 20%\\\u003CPTA ≤ 40% (or 1.5 ≤ INR\\\u003C2.6), and other reasons excluded.\n\nExclusion Criteria:\n\n1. Subjects with primary or metastatic liver cancer.\n2. Subjects with severe esophageal\u002Fgastric varices and high risk of bleeding, with positive red signs, or with previous active bleeding, as indicated by gastroscopy or imaging examination results.\n3. Serum creatinine was greater than 132.6 μmol\u002FL.\n4. Subjects with serious uncontrolled infections, including sepsis, septic shock, severe pneumonia (refers to the diagnostic criteria of the American Society of Infectious Diseases\u002FAmerican Thoracic Society for adult severe pneumonia in 2007), abdominal infection (exist Peritonitis manifestations or white blood cells in ascites\\>0.1 × 10 9\u002FL after reasonable antibiotic treatment), etc;",{"count":300,"type":21},92,[24,25],"This is a multicenter, randomized, controlled, open-label phase 1\u002F2 clinical study conducted in China to evaluate the efficacy, safety and tolerability of hiHep cell-based bio-artificial liver support system (HepaCure) plus DPMAS versus DPMAS alone in Chinese subjects with acute-on-chronic liver failure（ACLF）.\n\nPhase 1 is a multicenter, open label study to evaluate the safety and tolerability of single dose and multiple doses of HepaCure with different treatment duration plus DPMAS in ACLF subjects respectively.\n\nPhase 2 is a multicenter, randomized and controlled open label study to evaluate the efficacy, safety and tolerability of HepaCure plus DPMAS and LPE in ACLF subjects",[304,28,305],"Acute on Chronic Hepatic Failure","Hepatitis","2025-02-21",{"date":308,"type":33},"2025-02-25",{"date":310,"type":33},"2023-09-22",{"date":312,"type":21},"2026-09",{"name":314,"class":64},"Hexaell Biotech Co., Ltd.",{"id":316,"slug":4,"hasResults":10,"nctId":317,"briefTitle":318,"officialTitle":319,"acronym":4,"eligibilityCriteria":320,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":321,"enrollmentInfo":322,"targetDuration":4,"studyType":22,"phases":323,"briefSummary":324,"conditions":325,"keywords":328,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":332,"lastUpdatePostDateStruct":333,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":339,"locationsCount":41},"100579536","NCT06825572","MSC-EVs in Acute\u002F Acute-on-Chronic Liver Failure After Liver Transplantation","Mesenchymal Stem Cells-Derived Extracellular Vesicles (MSC-EV) in Acute\u002FAcute-on-Chronic Liver Failure After Liver Transplantationa：a Prospective, Randomized, Controlled Clinical Study","Inclusion Criteria:\n\n* aged 18-70 years;\n* Acute on chronic liver failure-which is characterized by acute hepatic insult manifesting as jaundice (serum total bilirubin \\[TBil\\] ≥ 10×ULN umol\u002FL) and coagulopathy (international normalized ratio \\[INR\\] ≥ 1.5 or prothrombin activity \\\u003C 40%), complicated within 4 weeks by ascites and\u002For encephalopathy as determined by physical examination, in patients with previously diagnosed or undiagnosed chronic liver disease; Requiring liver transplantation due to acute on chronic liver failure;\n* Obtain the patients' consent after informing patients of the purpose and method of the clinical trial;\n\nExclusion Criteria:\n\n* Past history of malignant disease\n* Active uncontrolled infection;\n* Combined transplantation\n* EBV-negative;\n* HIV or HCV positive;\n* Retransplantation;","70 Years",{"count":49,"type":21},[24],"Acute liver failure (ALF) refers to a potentially reversible disorder that was the result of severe liver injury, with an onset of encephalopathy within 8 weeks of symptom appearance and in the absence of pre-existing liver disease. Acute-on-chronic liver failure refers to a liver failure syndrome in which some patients with chronic liver disease with relatively stable liver function suffer from acute liver decompensation and liver failure due to the effects of various acute injury factors. Liver transplantation is the only curative treatment for this type of end-stage liver disease. The potential of MSCs to repair or regenerate damaged tissue and suppress immune responses makes them promising in the treatment of liver diseases, especially in the field of liver transplantation. Many studies have shown that MSC-based therapies can reduce the symptoms of liver disease due to their paracrine effects. Therefore, compared to the cells they derive from, mesenchymal stem cells-derived extracellular vesicles (MSC-EV) are gradually gaining attention for their enhanced safety, as they do not replicate or cause microvascular embolism, and can be easily stored without losing their properties. It represents a novel and effective cell-free therapeutic agent as alternative to cell-based therapies for liver diseases, and liver failure was also concerned. This study was designed to evaluate the safety and tolerability of MSC-EV in acute-on-chronic liver failure after liver transplantation.",[28,326,327],"Mesenchymal Stem Cell","Extracellular Vesicles",[329,330,331],"MSC-EV","Liver transplantation","Liver failure","2025-02-09",{"date":334,"type":33},"2025-02-13",{"date":336,"type":21},"2025-04-01",{"date":338,"type":21},"2026-09-30",{"name":340,"class":40},"Third Affiliated Hospital, Sun Yat-Sen University",{"id":342,"slug":4,"hasResults":10,"nctId":343,"briefTitle":344,"officialTitle":344,"acronym":345,"eligibilityCriteria":346,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":347,"targetDuration":4,"studyType":144,"phases":4,"briefSummary":348,"conditions":349,"keywords":351,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":355,"lastUpdatePostDateStruct":356,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":361,"locationsCount":4},"100575439","NCT06772298","Study of Oxidized Albumin in Liver Transplant Patients","SALT","Inclusion Criteria:\n\n* Patients on waiting list for liver transplantation\n\nExclusion Criteria:\n\n* none",{"count":123,"type":21},"The overall goal is to describe the oxidation state of albumin before, during and after liver transplantation. This is a pilot observational study in which the oxidative state in 10 patients undergoing liver transplantation will be described. Samples for analysing the oxidation state of albumin, general oxidative damage and anti-oxidant state, the activation of the complement system and factors involved in coagulation will be obtained before transplantation, before and after reperfusion of the portal vein and on postop days 1, 2 and about 30.",[28,245,350],"Liver Transplant Disorder",[352,353,354],"Oxidised albumin","Complement","Coagulation","2025-01-08",{"date":357,"type":33},"2025-01-13",{"date":359,"type":21},"2025-02-01",{"date":157,"type":21},{"name":362,"class":160},"Region Stockholm",{"id":364,"slug":4,"hasResults":10,"nctId":365,"briefTitle":366,"officialTitle":367,"acronym":4,"eligibilityCriteria":368,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":121,"enrollmentInfo":369,"targetDuration":4,"studyType":22,"phases":371,"briefSummary":372,"conditions":373,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":376,"lastUpdatePostDateStruct":377,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":41},"100476513","NCT05484908","Efficacy and Safety of ALSS Treatment for ICIs-LF in Patients With HCC","Efficacy and Safety of Artificial Liver Support System Treatment for Immune Checkpoint Inhibitors Related Liver Failure in Patients With Hepatocellular Carcinoma","Inclusion Criteria:\n\n1. Age from 18 to 65 years old;\n2. Clinical diagnosis of chronic hepatitis b virus infection (positive hepatitis b surface antigen or positive hepatitis b virus DNA \\> 0.5 year);\n3. Clinical diagnosis of hepatocellular carcinoma and receive immune checkpoint inhibitors treatment. The last treatment of immune checkpoint inhibitors is less than three months from inclusion;\n4. The level of hepatitis b virus DNA \\\u003C 2000 IU\u002FmL；\n5. Serum aspartate aminotransferase\u002Falanine aminotransferase \\> 20 times upper limit of normal；serum total bilirubin\\>10 times upper limit of normal；\n6. Prothrombin time international ratio \\> 1.5;\n7. Platelets \\> 50\\*10 E9\u002FL;\n8. Without intrahepatic bile duct dilation due to tumor progression.\n\nExclusion Criteria:\n\n1. Other active liver diseases;\n2. Other malignancy;\n3. Pregnancy or lactation;\n4. Human immunodeficiency virus infection or congenital immune deficiency diseases;\n5. Severe diabetes, autoimmune diseases; unstable infarction due to cardio-cerebrovascular events; other important organ dysfunctions or transplantation;\n6. Active bleeding, disseminated intravascular coagulation, thrombosis, or thrombotic disease;\n7. Patients received artificial liver support system treatment in one week before inclusion;\n8. Patients can not follow-up;\n9. Investigator considering inappropriate",{"count":370,"type":21},60,[76],"This study aims to investigate the efficacy and safety of artificial liver support system treatment for immune checkpoint inhibitors related liver failure in patients with hepatocellular carcinoma.",[374,28,375],"Immune-Mediated Hepatitis","Hepatocellular Carcinoma","2024-11-26",{"date":378,"type":33},"2024-11-29",{"date":380,"type":33},"2022-08-12",{"date":382,"type":21},"2024-12-31",{"name":340,"class":40},{"id":385,"slug":4,"hasResults":10,"nctId":386,"briefTitle":387,"officialTitle":388,"acronym":389,"eligibilityCriteria":390,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":391,"targetDuration":4,"studyType":144,"phases":4,"briefSummary":393,"conditions":394,"keywords":395,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":399,"startDateStruct":401,"completionDateStruct":403,"leadSponsor":404,"locationsCount":406},"100496469","NCT05744635","Assessment of the Pharmacokinetic Profile of Tacrolimus Medications and Their Relation to Effectiveness and Safety in Liver Transplant Patients","Assessment of the Pharmacokinetic Profile of Tacrolimus Medications in Liver Transplant Patients","LTA","Inclusion Criteria:\n\n1. Patients ≥ 18 years of age\n2. Patients after liver- or simultaneous liver and kidney transplantation\n3. Having received a tacrolimus containing immunosuppressant therapeutic regimen at least for four weeks (induction therapy), and TL is within 5-20 ng\u002Fml before inclusion\n4. Patients signed an informed consent form for use of their pseudonymised clinical data within the present non-interventional trial.\n\nExclusion Criteria:\n\n1. Participation in any clinical trial, 30 days prior to inclusion\n2. The patients received liver allograft more than 6 months before inclusion\n3. Hospitalisation due to infection, acute rejection, or graft disfunction 2 weeks prior to enrolment\n4. Chronic graft insufficiency in the patient's history\n5. Use of medications 2 weeks prior to enrolment, or the need for continuous use of medications that are known to significantly affect the pharmacokinetics of tacrolimus containing medications (as CYP3A4 inducers: rifampin, carbamazepine, phenobarbital, and phenytoin, or CYP3A4 inhibitors: erythromycin, ketoconazole, clarithromycin, and verapamil containing medication)\n6. Presence of the following comorbidities:\n\n   1. Diseases affecting adherence to therapy (Chronic neurologic conditions, Psychiatric diseases)\n   2. Diseases affecting drug absorption and metabolism (Inflammatory bowel disease, Chronic inflammatory diseases of bile ducts, Presence of ascites due to any disease)\n7. Patients on waiting list for re-transplantation",{"count":392,"type":21},110,"The goal of this observational study is oo compare the pharmacokinetic parameters of different tacrolimus containing medications in liver transplant patients. The main question\\[s\\] it aims to answer are:\n\n* Differences in pharmacokinetic parameters of tacrolimus containing medicinal products (TL, TDD and their ratio - C\u002FD)\n* Changes in liver function parameters compared to baseline.\n* Change in the estimated glomerular filtration rate (eGFR) compared to baseline.\n* To assess the possible relation of liver function parameters and eGFR to C\u002FD (blood concentration and daily dosage)\n* Incidence of acute graft rejection during the study\n* Incidence of BK and cytomegalovirus (CMV) infection during the study\n* To assess the intraindividual variability of the TL, TDD and the ratios of these parameters (C\u002FD)\n* To assess the patient-adherence of therapy based on the BAASIS questionnaire, and prescription filled by individual patients, based on electronic health-care record.\n\nParticipants will not have to undergo any additional clinical visits or tests except which are required in routine clinical care",[28],[330,396,397],"Immunosuppression","Tacrolimus","2024-08-21",{"date":400,"type":33},"2024-08-22",{"date":402,"type":33},"2023-05-10",{"date":55,"type":21},{"name":405,"class":64},"Chiesi Hungary Ltd.",2,{"id":408,"slug":4,"hasResults":10,"nctId":409,"briefTitle":410,"officialTitle":410,"acronym":411,"eligibilityCriteria":412,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":413,"targetDuration":4,"studyType":144,"phases":4,"briefSummary":414,"conditions":415,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":419,"completionDateStruct":421,"leadSponsor":422,"locationsCount":41},"100533300","NCT06224023","Predictive Values of Presepsin Levels in ASciteS in Patients With Chronic Liver Failure","PASS","Inclusion Criteria:\n\n* patient with ascites and chronic liver failure\n* no contraindications and technical possibility to perform diagnostic paracentesis\n* age above 18 years old\n* informed consent\n\nExclusion Criteria:\n\n* contraindications to paracentesis or technical impossibility to perform paracentesis\n* absence of informed consent",{"count":49,"type":21},"The investigators aim to study the predictive value of presepsin in ascites in newly admitted patients with chronic liver failure.",[416,28,221],"Ascites Hepatic","2024-08-20",{"date":398,"type":33},{"date":420,"type":33},"2024-08-01",{"date":382,"type":21},{"name":423,"class":40},"Carol Davila University of Medicine and Pharmacy",{"id":425,"slug":4,"hasResults":10,"nctId":426,"briefTitle":427,"officialTitle":427,"acronym":4,"eligibilityCriteria":428,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":429,"enrollmentInfo":430,"targetDuration":4,"studyType":144,"phases":4,"briefSummary":432,"conditions":433,"keywords":435,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":438,"lastUpdatePostDateStruct":439,"startDateStruct":440,"completionDateStruct":442,"leadSponsor":443,"locationsCount":41},"100556984","NCT06532214","Clinical Retrospective Study Analysis of Postoperative Complications Following Hepatectomy","Inclusion Criteria:\n\n* 1\\. Patients aged 18-80 years 2.Patients who underwent liver resection surgery at the participating centers\n\nExclusion Criteria:\n\n* Exclusion criteria are as follows:\n\n  1. Prior cancer treatments such as transarterial chemoembolization, ablation, or targeted therapy.\n  2. Repeat liver resection surgeries.\n  3. Presence of other malignancies.\n  4. Concurrent end-stage diseases including active infections, respiratory failure, decompensated heart failure, and autoimmune disease exacerbations.\n  5. Inadequate clinical data availability in medical records.","80 Years",{"count":431,"type":21},2000,"Hepatectomy is a crucial surgical method for treating liver diseases such as liver cancer, hepatic hemangiomas, and biliary stones. Although hepatectomy has achieved significant therapeutic effects, postoperative complications remain an inevitable issue. Complications following hepatectomy include liver failure, hepatic vascular thrombosis, wound infection at the hepatic incision, and bile leakage, among others. These complications pose a serious threat to patients' health and life, and also increase the waste of medical resources and the cost of treatment. Currently, research on postoperative complications of hepatectomy mainly focuses on small sample studies from a single center, and most studies only focus on a specific complication, lacking comprehensive and systematic analysis. Therefore, it is necessary to conduct a retrospective study analysis of complications related to hepatectomy to more comprehensively and objectively understand the incidence, risk factors, prevention, and treatment of postoperative complications, providing clinical doctors with more scientific treatment plans and guidance.",[28,434],"Liver Dysfunction",[436,282,437],"hepatectomy","Post-hepatectomy liver failure","2024-07-29",{"date":420,"type":33},{"date":441,"type":33},"2024-01-01",{"date":290,"type":21},{"name":444,"class":40},"Nanfang Hospital, Southern Medical University",{"id":446,"slug":4,"hasResults":10,"nctId":447,"briefTitle":448,"officialTitle":449,"acronym":4,"eligibilityCriteria":450,"healthyVolunteers":451,"sex":16,"minAge":17,"maxAge":121,"enrollmentInfo":452,"targetDuration":4,"studyType":22,"phases":453,"briefSummary":454,"conditions":455,"keywords":456,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":462,"completionDateStruct":464,"leadSponsor":465,"locationsCount":41},"100452397","NCT05170971","Fecal Microbiota Transplantation for Liver Failure","The Clinical Efficacy and Safety of Fecal Microbiota Transplantation in Patients With Acute-on-chronic Liver Failure","Inclusion Criteria:\n\n* Patients willing to sign informed consent\n* Patients aged 18-65\n* According to the diagnosis standard of liver failure in the guide for diagnosis and treatment of liver failure (2018 Edition), the eligible patients are included, that is, on the basis of chronic liver disease, the syndrome with acute jaundice deepening and coagulation dysfunction as the manifestation of liver failure caused by various inducements can be combined with complications such as Hepatoencephalopathy, ascites, electrolyte disorder, infection, hepatorenal syndrome, hepatopulmonary syndrome, etc And extrahepatic organ failure. The patient's jaundice deepened rapidly, the serum TBIL ≥ 10 × ULN or the daily rise ≥ 17.1 μ mol \u002F L; there was bleeding, PTA ≤ 40% (or INR ≥ 1.5)\n\nExclusion Criteria:\n\n* Patients with severe heart failure, COPD, cerebrovascular accident, nephrotic syndrome, etc;\n* Patients with gastrointestinal bleeding, pulmonary infection, septicemia, etc\n* Patients with liver cancer, lung cancer, lymphoma and other malignant tumors\n* Patients taking anticoagulants, mental diseases and immune diseases for a long time\n* Pregnant or lactating women.",true,{"count":370,"type":21},[76],"To investigate the safety, adverse reactions and therapeutic effects of fecal microbiota transplantation on patients with liver failure;to investigate the effect of fecal microbiota transplantation on the intestinal microecology and \"gut-liver axis immune system\" of liver failure, and further optimization of fecal microbiota transplantation technology.",[28],[457,458,282],"fecal microbiota transplantation","gut-liver axis","2024-03-08",{"date":461,"type":33},"2024-03-12",{"date":463,"type":33},"2021-05-01",{"date":157,"type":21},{"name":466,"class":160},"Ningbo Medical Center Lihuili Hospital",{"id":468,"slug":4,"hasResults":10,"nctId":469,"briefTitle":470,"officialTitle":470,"acronym":4,"eligibilityCriteria":471,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":321,"enrollmentInfo":472,"targetDuration":4,"studyType":144,"phases":4,"briefSummary":473,"conditions":474,"keywords":475,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":479,"lastUpdatePostDateStruct":480,"startDateStruct":482,"completionDateStruct":484,"leadSponsor":486,"locationsCount":4},"100536995","NCT06272071","A Multicenter Prospective Clinical Cohort Study on the Pathogen Spectrum of Severe Hepatitis (Liver Failure) Complicated With Infection","Inclusion Criteria:\n\n1. Patients agreed to participate in the study and signed an informed consent form;\n2. Sex is not limited and age is 18-70 years old;\n3. HBsAg positive for more than 6 months, or hepatitis E IgM positive, or hepatitis E RNA positive;\n4. Progressive deepening of jaundice in a short period of time (serum total bilirubin greater than 10 times the upper limit of normal or rising ≥17.1 umol\u002FL per day);\n5. Sgnificant bleeding tendency with PTA ≤ 40% and exclusion of other non-hepatic factors.\n\nExclusion Criteria:\n\n1. Patients with severe hepatitis caused by other non-hepatophilic viral infections;\n2. Patients who were considered by the investigator to be unsuitable for participation in the study.",{"count":431,"type":21},"The goal of this observational study is to expound the population and characteristics of pathogenic microorganisms with co-infection, draw the pedigree of pathogenic microorganisms, and evaluate its influence on disease outcome in patients with severe hepatitis (liver failure). The main questions it aims to answer are:\n\n* Mapping of infectious agents in patients with severe hepatitis (liver failure)\n* Constructing early warning predictive models to explore how to give an individualized regimen of integrated immune function.",[28],[476,477,478],"Severe hepatitis","Pathogen pedigree of infection","cohort study","2024-03-01",{"date":481,"type":33},"2024-03-04",{"date":483,"type":21},"2024-03",{"date":485,"type":21},"2026-11",{"name":487,"class":40},"Zhejiang University",{"id":489,"slug":4,"hasResults":10,"nctId":490,"briefTitle":491,"officialTitle":492,"acronym":493,"eligibilityCriteria":494,"healthyVolunteers":10,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":495,"targetDuration":497,"studyType":144,"phases":4,"briefSummary":498,"conditions":499,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":500,"lastUpdatePostDateStruct":501,"startDateStruct":503,"completionDateStruct":505,"leadSponsor":507,"locationsCount":509},"100496166","NCT05740696","Registry Study for Optimal Management of Liver Failure in the Chinese Population","Registry Study for Optimal Management of Liver Failure in the Chinese Population (RESOLVE-C)","RESOLVE-C","Inclusion Criteria:\n\nPatients with a diagnosis consistent with liver failure and pre-liver failure:\n\n* Extreme weakness with significant gastrointestinal symptoms such as anorexia, vomiting and abdominal distention;\n* Elevated alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) with progressive jaundice (TBil≥85.5 μmol\u002FL);\n* Bleeding tendency with PTA ≤ 60% or INR ≥ 1.5.\n\nExclusion Criteria:\n\n* An event or complication that, in the judgment of the investigator, significantly affects the assessment of clinical status.",{"count":496,"type":21},500,"2 Years","Liver failure is the most severe form of liver damage caused by viral, alcoholic, drug-related and ischemia-reperfusion factors, often combined with extrahepatic organ damage, resulting in a high mortality rate. This study intends to construct a real-world case registry database of inpatients with liver failure based on an electronic clinical data collection system through a multicenter collaborative network to study the clinical characteristics, epidemiology of bacterial and fungal infections, the impact of sarcopenia on clinical prognosis, and optimization of treatment strategies such as antiviral and artificial liver in Chinese inpatients with liver failure. The cohort and experience generated from this study will be used as a support for a series of future studies to focus on clinical issues such as infection, end-stage liver disease combined with organ failure, and early warning of critically ill patients.",[28],"2023-02-22",{"date":502,"type":33},"2023-02-23",{"date":504,"type":33},"2023-01-06",{"date":506,"type":21},"2028-12-30",{"name":508,"class":40},"First Affiliated Hospital Xi'an Jiaotong University",14,""]