[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-on-chronic-liver-failure\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-on-chronic-liver-failure":112},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,27,0,25,[9,45,78,100,123,144,172,197,233,259,282,305,333,353,376,396,418,435,452,471,495,514,535,555,577],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100441607","the-effects-of-double-plasma-molecular-adsorption-system-in-acute-on-chronic-liver-failure-patients-100441607",false,"NCT05030571","The Effects of Double Plasma Molecular Adsorption System in Acute on Chronic Liver Failure Patients","Inclusion Criteria:\n\n1. Age 18 or more\n2. Diagnosis of Acute ontop chronic liver failure by Asian Pacific association for the study of the liver (APASL) criteria\n3. Admitted to intensive care unit\n\nExclusion Criteria:\n\n1. Pregnancy\n2. Received steroid treatment\n3. Expected dead within 24 hour\n4. WBC \\\u003C 500\u002Fmm3\n5. Allergy to DPMAS\n6. History of organ transplant\n7. Terminal illness with do not resuscitation order","ALL","18 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"NA","Acute liver failure patients posed high mortality rate despite receiving standard therapy. The severity and mortality even higher in patients with underlying liver disease. Acute liver failure cause hyperinflammatory response in early stage and immunoparalysis in later stage. The surge of proinflammatory cytokines leads to multiorgan failure and more liver injury. Subsequent immunoparalysis may lead to lethal secondary infections.\n\nLiver support system had been used in acute and acute ontop chronic liver disease for last several decades. Double plasma molecular adsorption system (DPMAS) is one of the promising non-biological liver support system that have been extensively investigated in acute ontop chronic liver failure from hepatits B viral. DPMAS circuit consist of BS330 (bilirubin adsorber) and HA330 (Cytokines adsorber). Thus, DPMAS can also remove various cytokines. The effect of DPMAS on immune function in these patients has not been explored.\n\nRecent randomized controlled trial by Srisawat et al. demonstrated improvement of mHLA-DR in septic shock patients who received polymyxin B extracorporeal therapy compare to control arm. Since liver failure show change of immunological profile resemble to sepsis. Investigators proposed that removal of toxic liver toxins and lethal cytokines by DPMAS will improve immunological profiles in acute ontop chronic liver failure patients.\n\nInvestigators plan to conduct a randomized controlled trial in acute ontop chronic liver failure patients who admitted to intensive care unit. Investigators plan to compare the immunomodulatory effects of DPMAS with standard treatments.",[26,27],"Acute-On-Chronic Liver Failure","Acute on Chronic Hepatic Failure",[29,26,30,31],"Hemoperfusion","Cytokine adsorbant therapy","HA-330","RECRUITING","2026-06-15",{"date":35,"type":36},"2026-06-16","ACTUAL",{"date":38,"type":36},"2021-01-01",{"date":40,"type":20},"2027-04-01",{"name":42,"class":43},"Chulalongkorn University","OTHER",1,{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":60,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":44},"100522161","cooley--study-acute-on-chronic-liver-failure-using-the-cytosorb-device-100522161","NCT06079021","COOLEY- Study: aCute On chrOnic Liver failurE Using the cYtosorb Device","COOLEY","Inclusion Criteria:\n\n* adult patients (≥ 18 years) admitted to the University Hospital of Antwerp (UZA), Belgium.\n\n  * Written informed consent from patient or if not possible due to encephalopathy (\\> grade 2): legal representative\n  * acute-on-chronic liver failure (ACLF) grade ≥ 2:\n\n    * Acute decompensation event (identifiable trigger)\n    * Hepatic encephalopathy grade ≥ 2\n    * Acute kidney injury (AKI) according to Kidney Disease: Improving Global Outcome (KDIGO) criteria stage 3 (≥ 3-fold increase of serum creatinine OR increase of serum creatinine to ≥ 4 mg\u002Fdl OR urine output ≤ 0.3 ml\u002Fkg\u002Fh for ≥ 24 hours OR anuria for ≥ 12 hours)\n    * Serum bilirubin ≥ 10 mg\u002Fdl\n    * Hemodynamic instability with vasopressor support (norepinephrine \\> 0.05 mcg\u002Fkg\u002Fmin)\n\nExclusion Criteria:\n\n* • known patient will against participation in the study or against the measures applied in the study\n\n  * a decision made prior to inclusion to stop further treatment of the patient within the next 24 hours\n  * no complete remission of malignancy including hepatocellular carcinoma within the past 12 months\n  * ongoing intermittent or CRRT before study inclusion",{"count":53,"type":20},20,[23],"A Prospective, Single-Center trial, in Patients With Acute on Chronic Liver Failure. Study of Standard Medical Care Plus CytoSorb® Compared to Standard Medical Care Alone in a historical group.",[26,57,58,59],"Anticoagulant Adverse Reaction","Sarcopenia","Ultrasonography",[61,62,63,64,65,66,67,68],"acute on chronic liver failure","sarcopenia","citrate anticoagulation","low molecular weight heparins","hand grip strength","skeletal muscle ultrasound","hemoadsorption","CRRT","2026-04-27",{"date":71,"type":36},"2026-05-01",{"date":73,"type":36},"2024-06-08",{"date":75,"type":20},"2027-12-31",{"name":77,"class":43},"University Hospital, Antwerp",{"id":79,"slug":80,"hasResults":12,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":21,"phases":88,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":98,"locationsCount":44},"100559336","efficacy-and-safety-of-cytokine-adsorption-and-plasma-exchange-in-patients-with-aclf-and-sepsis-100559336","NCT06562803","Efficacy and Safety of Cytokine Adsorption and Plasma Exchange in Patients With ACLF and Sepsis","Efficacy and Safety of Double Plasma Cytokine Adsorption System With Sequential Low-Dose Plasma Exchange in Treating Acute-on-Chronic Liver Failure and Sepsis: A Multi-center Randomized Controlled Study","Inclusion Criteria:\n\n1. Age between 18 and 70 years with a background of chronic liver disease, regardless of the presence of cirrhosis.\n2. Total bilirubin (TBIL) \\> 12 mg\u002FdL.\n3. International normalized ratio (INR) ≥ 1.5.\n4. Meeting the diagnostic criteria for sepsis: confirmed or suspected infection, with a sequential organ failure assessment (SOFA) score increase of ≥ 2 points. (5) High inflammatory status: IL-6 \\> 80 pg\u002Fml.\n\n(6) Diagnosis of sepsis within the past 72 hours.\n\nExclusion Criteria:\n\n1. Inherited metabolic liver disease (including Wilson's disease, hereditary hemochromatosis, and alpha-1 antitrypsin deficiency).\n2. Patients with hepatocellular carcinoma or other malignancies.\n3. Pregnant or breastfeeding women.\n4. Patients with human immunodeficiency virus (HIV) infection or other immunodeficiency diseases (including active hematological malignancies, congenital immunodeficiency syndromes, or those currently receiving high-dose systemic immunosuppressive therapy).\n5. Unstable phase of cerebrovascular events.\n6. History of organ transplantation.\n7. Patients with irreversible or terminal extrahepatic organ failure that precludes safe extracorporeal circulation or confounds the intervention: ①Terminal chronic obstructive pulmonary disease, terminal cor pulmonale, brain death, or persistent vegetative state, or Grade IV hepatic encephalopathy. ②Requirement for renal replacement therapy (RRT) at the time of screening\u002Fenrollment. ③Despite adequate fluid resuscitation, vasopressors, and steroid treatment, unable to maintain mean arterial pressure above 65 mmHg.\n8. Platelet count \\\u003C 50×10E9\u002FL, severe coagulation disorders (INR\\>3.5), or active bleeding.\n9. Known allergies to extracorporeal circulation, hemoperfusion, or other severe allergic history.\n10. Refusal by the patient or their legally authorized representative (LAR) to participate in the study, or sign the informed consent form.\n11. Inability to return for regular follow-up visits as planned in the study.\n12. Other conditions that, in the judgment of the researchers, make the patient unsuitable for enrollment.","70 Years",{"count":87,"type":20},192,[23],"This study aims to evaluate the efficacy and safety of the double plasma cytokine adsorption system with sequential low-dose plasma exchange (DPCAS+LPE) in patients with acute-on-chronic liver failure (ACLF) complicated by sepsis. The focus is on assessing the impact of the cytokine adsorption column(CA280,Jafron Biomedical Co., Ltd., Zhuhai, China) on survival rates, inflammation markers, and organ function to determine its potential value in clinical practice.\n\nThe primary research questions are: (1) Does DPCAS+LPE artificial liver therapy improve the 4-week mortality rate in ACLF patients with sepsis? (2) Does it improve the 12-week mortality rate in these patients? Additionally, the study examines the effects of this therapy on APACHE II scores, SOFA scores, vasoactive-inotropic score, MELD scores, and COSSH-ACLF II scores, as well as the cytokine adsorption efficiency of the CA280.\n\nPatients were randomly assigned to either the DPCAS+LPE group or the plasma exchange(PE) group. All patients received artificial liver therapy every other day, for a total of two sessions. Follow-up assessments were conducted before and after each therapy session, as well as at 1, 2, 3, 4, and 12 weeks.",[26,91],"Sepsis","2026-04-26",{"date":94,"type":36},"2026-04-30",{"date":96,"type":36},"2024-09-27",{"date":75,"type":20},{"name":99,"class":43},"Third Affiliated Hospital, Sun Yat-Sen University",{"id":101,"slug":102,"hasResults":12,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":21,"phases":109,"briefSummary":110,"conditions":111,"keywords":4,"overallStatus":113,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":44},"100625462","efficacy-and-safety-of-early-initiation-of-midodrine-for-control-and-prevention-of-ascites-and-its-related-complications-in-acute-on-chronic-liver-failure-100625462","NCT07422948","Efficacy and Safety of Early Initiation of Midodrine for Control and Prevention of Ascites and Its Related Complications in Acute-on-chronic Liver Failure.","Efficacy and Safety of Early Initiation of Midodrine for Control and Prevention of Ascites and Its Related Complications in Acute-on-chronic Liver Failure: A Randomized Controlled Trial.","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. ACLF\n3. Ascites (Grade II\u002FIII).\n4. Willing\u002Fable for salt restriction, labs, urine collections, and follow-ups; consent obtained.\n\nExclusion Criteria:\n\n1. SCr ≥ 1.5 mg\u002FdL OR ongoing AKI \\>stage I\n2. Persistent or uncorrectable severe hyponatremia (Na ≤120 mEq\u002FL), hyperkalemia (\\>6.0 mEq\u002FL) or any other critical electrolyte imbalance.\n3. Refractory ascites\n4. Spontaneous bacterial peritonitis\n5. Hepatic encephalopathy grade II-III.\n6. Shock, need for IV vasopressors, SBP \\\u003C90 mmHg or MAP \\\u003C65 despite fluids\u002Falbumin.\n7. Active GI bleed, uncontrolled infection\u002Fsepsis, or SBP at screening.\n8. Severe cardiomyopathy, critical valvular disease, arrhythmias contraindicating α-agonists.\n9. ACLF patients on Mechanical ventilation\u002FICU\u002Fionotropes\u002FHigh flow oxygen\n10. Pregnancy, lactation.\n11. Hypersensitivity\u002Fintolerance to midodrine.\n12. Significant LUTS.",{"count":108,"type":20},113,[23],"Ascites is a cardinal and debilitating complication in patients with acute-on-chronic liver failure (ACLF), significantly correlating with disease severity and poor prognosis. The underlying pathophysiology is driven by severe splanchnic arterial vasodilation, which reduces effective arterial blood volume and triggers compensatory neurohumoral activation. This cascade leads to profound sodium retention, renal vasoconstriction, and circulatory instability. Consequently, patients with ACLF frequently experience diuretic intolerance and are at elevated risk for severe complications, including electrolyte disturbances, acute kidney injury (AKI), and hepatorenal syndrome (HRS).\n\nCurrent management strategies rely heavily on diuretics and albumin; however, the efficacy of diuretics is often limited by systemic hypotension and pre-existing renal impairment, leading to frequent treatment failure or diuretic-induced complications. Existing clinical guidelines lack definitive recommendations regarding the preemptive use of vasoconstrictors to stabilize hemodynamics before ascites becomes refractory. Midodrine, an oral alpha-1 adrenergic agonist, targets this circulatory dysfunction by increasing systemic vascular resistance and improving renal perfusion. This randomized controlled trial aims to evaluate the efficacy and safety of the early initiation of midodrine in achieving better control of ascites and preventing the progression to renal complications in patients with acute-on-chronic liver failure.",[112],"Acute on Chronic Liver Failure","NOT_YET_RECRUITING","2026-02-13",{"date":116,"type":36},"2026-02-20",{"date":118,"type":20},"2026-02-05",{"date":120,"type":20},"2027-08-30",{"name":122,"class":43},"Institute of Liver and Biliary Sciences, India",{"id":124,"slug":125,"hasResults":12,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":132,"phases":4,"briefSummary":133,"conditions":134,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":44},"100608230","risk-factors-affecting-msc-efficacy-in-aclf-patients-100608230","NCT07198854","Risk Factors Affecting MSC Efficacy in ACLF Patients","Analysis of Risk Factors Affecting Mesenchymal Stem Cells Efficacy in Hepatitis B Related Acute-on-chronic Liver Failure","Inclusion Criteria:\n\n* Clinical diagnosis of acute-on-chronic liver failure; Positive serum HBV surface antigen for more than 6 months; Received MSCs infusion more than one time.\n\nExclusion Criteria:\n\n* Systemic or local malignancy; Hepatitis C virus infection; HIV infection or other immunodeficiency disease; Marked organ dysfunction (e.g., renal dysfunction); Pregnancy or lactation; Hyperthyroidism or other primary thyroid diseases; Incomplete data or lost to follow-up; Hospital stay \\\u003C 1 day.",{"count":131,"type":20},446,"OBSERVATIONAL","Mesenchymal stromal cells (MSCs) are potential therapy for many diseases, with the ability of tissue regeneration, repair and immunomodulation. Acute-on-chronic liver failure (ACLF) is a severe disease with high mortality. Previous studies showed that MSCs can improve the outcomes of Hepatitis B virus (HBV)-related ACLF patients. However, there are still some ACLF patients who have not benefited from MSC treatment. Thus, searching for risk factors affecting MSC efficacy in ACLF patients is of great significance for promotion of MSCs therapy.\n\nThis retrospective study will perform at a single center in southern China. Consecutive HBV related-ACLF patients treated with MSCs at the Third Affiliated Hospital of Sun Yat-sen University from January 2010 to October 2018 will be included. The clinical data including survival status, liver functions, complications et al. will be collected and analyzed, with the purpose of identifying the risk factors of HBV-related ACLF patients received MSCs injection and improving the efficacy of MSCs therapy furtherly.",[26],"2025-11-22",{"date":137,"type":36},"2025-11-28",{"date":139,"type":36},"2025-10-20",{"date":141,"type":20},"2026-06-30",{"name":143,"class":43},"Sun Yat-sen University",{"id":145,"slug":146,"hasResults":12,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":4,"eligibilityCriteria":150,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":151,"enrollmentInfo":152,"targetDuration":4,"studyType":21,"phases":154,"briefSummary":156,"conditions":157,"keywords":159,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":171},"100492246","phase-2-f573-for-injection-for-the-treatment-of-liver-injuryfailure-100492246","NCT05689645","F573 for Injection for the Treatment of Liver Injury\u002FFailure","F573 for Injection for the Treatment of Liver Injury\u002FFailure : Randomized, Double-blind, Placebo-controlled Phase Ⅱa Clinical Trial","Inclusion Criteria:\n\n（1）The first stage:\n\nParticipants who meet all of the following criteria will be enrolled in the study:\n\n1. Age ≥18 and ≤60 years old, gender is not limited;\n2. Patients with liver injury clinically diagnosed with hepatocyte injury or mixed liver injury or CHB patients with hepatitis B virus infection for more than 6 months (refer to the \"Chronic Hepatitis B Prevention and Treatment Guidelines (2019 edition)\"). Screening patients with CHB may provide etiological (HBsAg positive and\u002For HBV DNA positive) or clinical or pathological evidence (liver tissue biopsy results) that HBV infection has been present for more than 6 months.\n3. Serum ALT: 2\\~ 10× upper limit of normal (ULN), TBil: \\\u003C5×ULN;\n4. DILI patients: the abnormal duration of liver biochemical indexes \\[ALT, AST, ALP, gamma-glutamyltranspeptides (GGT), TBil, albumin, prothrombin time\\] does not exceed 90 days;\n5. The subject (including the partner) is willing to take effective contraceptive measures from the screening until 6 months after the last test drug administration;\n6. Sign informed consent and be able to comply with the requirements of the program; If the subject is unable to sign the informed consent form, it must be signed by a legal guardian or witness as required by the regulations.\n\n(2)The second stage:\n\nSubjects meeting all of the following criteria will be included in the study:\n\n1. Age ≥ 18 and ≤ 65 years old, with no gender restrictions;\n2. According to the \"Chinese Guidelines for the Diagnosis and Treatment of Drug-Induced Liver Injury (2023 Edition)\", patients diagnosed with drug-induced liver injury (DILI) or those diagnosed with intrahepatic cholestasis type liver injury. Patients with DILI and intrahepatic cholestasis type liver injury need to meet the following criteria separately;\n\n   1. Patients with DILI need to simultaneously meet the following conditions: ① Serum ALT \\> 3 times the upper limit of normal (ULN), and TBil \\> 2 times the ULN (the ULN of TBil refers to 17.1 μmol\u002FL according to international standards); ② Abnormal liver biochemical indicators (ALT, AST, ALP, TBil) persist for no more than 60 days;\n   2. Patients with intrahepatic cholestasis type liver injury need to simultaneously meet the following conditions: ① TBil \\> 2 times the ULN (the ULN of TBil refers to 17.1 μmol\u002FL); ② ALP \\> 1.5 times the ULN; ③ALT\\>1×ULN;\n3. The subjects (including their partners) are willing to voluntarily adopt effective contraceptive measures from the time of the initial screening until 6 months after the last administration of the investigational drug;\n4. They have signed the informed consent form and can comply with the requirements of the protocol; if the subjects are unable to sign the informed consent form, it must be signed by a legal guardian or a witness as required by the regulations.\n\nThe third stage:\n\nSubjects who meet all of the following criteria will be enrolled in the study:\n\n1\\. Age ≥18 and ≤70 years old, gender is not limited; 2. Patients diagnosed with chronic and acute liver failure with TBil≥5×ULN according to the \"Guidelines for Diagnosis and Treatment of Liver Failure (2018 Edition)\" may have hepatic encephalopathy (Grade 1-2) or ascites (grade 1-2) 4 weeks before subject screening. And 5≤AARC score ≤10 (AARC rating I-II); 3. The subject (including the partner) is willing to take effective contraceptive measures from the screening until 6 months after the last trial drug administration; 4. Sign informed consent and comply with the requirements of the program; If the subject is unable to sign the informed consent form, it must be signed by a legal guardian or witness as required by the regulations.\n\n\\-\n\nExclusion Criteria:\n\nThe first stage:\n\nSubjects meeting one of the following conditions will not be included in the trial:\n\n1. According to the investigator's judgment, the subjects were patients with cholestatic liver injury;\n2. Previous diagnosis of cirrhosis or liver hardness determination (LSM) at screening ≥ 12.4kPa;\n3. Patients with severe or life-threatening heart, lung, brain, kidney, gastrointestinal and systemic diseases, and patients with malignant tumors;\n4. There are the following laboratory test values or abnormal test values:\n\n   1. Blood routine: platelet (PLT) \\\u003C75× 109\u002FL, hemoglobin (HGB) \\\u003C90 g\u002FL;\n   2. Prothrombin activity \\\u003C40%, prothrombin time (PT) extended \\>5 s;\n   3. Left ventricular ejection fraction (LVEF) \\\u003C50%;\n5. Allergic or intolerant to the investigational drug, or allergic;\n6. The subject is unable to express his main complaint, such as mental illness and severe neurosis;\n7. Poor compliance can not partner;\n8. Pregnant women, breastfeeding women or women of childbearing age who are trying to conceive;\n9. Participants in other clinical trials within 3 months;\n10. Patients who had used liver protection drugs other than ursodeoxycholic acid or adenosylmethionine within 3 days before randomization;\n11. The researcher considers any circumstances unsuitable for inclusion.\n\nThe second stage:\n\nSubjects meeting one of the following conditions will not be included in the trial:\n\n1. The diagnosis is advanced liver cirrhosis (with complications such as ascites and hepatic encephalopathy), or liver cancer, or when liver stiffness measurement (LSM) is ≥ 18.0 kPa during screening.\n2. Patients with severe or life-threatening heart, lung, brain, kidney, gastrointestinal and systemic diseases are malignantTumor patients;\n3. There are the following laboratory test values or abnormal test values:\n\n   1. Blood routine: platelet (PLT) \\\u003C100×109\u002FL, hemoglobin (HGB) \\\u003C100 g\u002FL;\n   2. INR\\>1.4, or as determined by the investigator to meet the criteria for severe hepatitis;\n   3. Left ventricular ejection fraction (LVEF) \\\u003C50%;\n4. Allergic or intolerant to the investigational drug, or allergic;\n5. The subject is unable to express his main complaint, such as mental illness and severe neurosis;\n6. Poor compliance can not partner;\n7. Pregnant women, breastfeeding women or women of childbearing age who are trying to conceive;\n8. Participants in other clinical trials within 3 months;\n9. Patients who had used liver protection drugs other than ursodeoxycholic acid or adenosylmethionine and basic therapeutic drugs (polyene phosphatidylcholines and glutathione drugs) within 3 days before randomization;\n10. Patients who had used glucocorticoids or interferon drugs within 3 days before randomization;\n11. The researcher considers any circumstances unsuitable for inclusion.\n\nThe third stage:\n\nSubjects meeting one of the following conditions will not be included in the trial:\n\n1. Patients who have completed liver transplantation or plan to undergo liver transplantation within 1 month;\n2. Severe grade 3 ascites or stubborn ascites;\n3. Patients with ≥ grade 3 hepatic encephalopathy;\n4. Patients who received artificial liver treatment within 1 week before screening;\n5. Patients with severe underlying diseases, such as respiratory system, digestive system, circulatory system, endocrine and other diseases and malignant tumors, and patients with severe infections that cannot be controlled by drugs;\n6. During the screening period or within 1 month before screening, the results of gastroscopy or imaging (abdominal B-ultrasound, CT or MRI) examination suggest severe varicose veins with bleeding risk;\n7. Patients with acute kidney injury (AKI), defined as meeting one of the following conditions:\n\n   1. Serum creatinine (Scr) increased ≥26.5 μmol\u002FL (0.3 mg\u002FdL, 1 mg\u002FdL=88.4 μmol\u002FL) within 48 h;\n   2. The Scr increase exceeds 1.5 times or more of the base value within 7 days;\n   3. Decreased urine volume (\\\u003C0.5 mL\u002Fkg\u002Fh) for more than 6 hours;\n8. Allergic or intolerant to the investigational drug, or allergic;\n9. The subject is unable to express his main complaint, such as mental illness and severe neurosis;\n10. Poor compliance can not partner; 11 Pregnant women, breastfeeding women or women of childbearing age who are trying to conceive;\n\n12\\. Participants in other clinical trials within 3 months; 13. The researcher considers any circumstances unsuitable for inclusion.","60 Years",{"count":153,"type":20},97,[155],"PHASE2","This study was a randomized, double-blind, placebo-controlled PhaseⅡ clinical trial .\n\nThe primary objective of this study was to evaluate the safety of F573 for injection in patients with liver injury (drug-induced liver injury (DILI), chronic hepatitis B (CHB), intrahepatic cholestatic liver injury, etc.).",[158,26],"Acute Liver Failure",[160],"F573 for injection Liver Injury\u002FFailure","2025-11-17",{"date":163,"type":36},"2025-11-19",{"date":165,"type":36},"2023-03-24",{"date":167,"type":20},"2026-09-01",{"name":169,"class":170},"Beijing Continent Pharmaceutical Co, Ltd.","INDUSTRY",10,{"id":173,"slug":174,"hasResults":12,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":178,"eligibilityCriteria":179,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":180,"enrollmentInfo":181,"targetDuration":4,"studyType":132,"phases":4,"briefSummary":183,"conditions":184,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":196},"100409625","liver-transplantation-in-patients-with-cirrhosis-and-severe-acute-on-chronic-liver-failure-indications-and-outcomes-100409625","NCT04613921","Liver Transplantation in Patients With CirrHosis and Severe Acute-on-Chronic Liver Failure: iNdications and outComEs","Liver Transplantation in Patients With CirrHosis and Severe Acute-on-Chronic Liver Failure (ACLF): iNdications and outComEs","CHANCE","Inclusion Criteria:\n\n* 1\\. Male or female subject ≥18 years of age.\n\n  2\\. Subjects with diagnosis of liver cirrhosis (based on clinical, laboratory, endoscopic, and ultrasonographic features or on histology).\n\n  3\\. Subjects who have been hospitalized for acute decompensation of liver cirrhosis and referred to the transplant team:\n* Group 1: patients listed for liver transplantation with ACLF-2 or 3 at the time of listing or developing ACLF 2-3 while on the waiting list.\n* Group 2: patients listed for liver transplantation with decompensated cirrhosis without ACLF-2 or 3 and poor liver function (MELD\\>20) at the time of listing.\n* Group 3: patients having ACLF-2 or 3, are assessed for inclusion in the waiting list, but are finally not listed for liver transplantation.\n\n  4\\. Patients (or trusted person, family member or close relation if the patient is unable to express consent) who have been informed and signed their informed consent Inclusion criteria\n\nExclusion Criteria:\n\n\\-","80 Years",{"count":182,"type":20},3000,"Management of ACLF is mainly supportive. The poor outcomes lead physicians to consider liver transplantation as an option, even if controversial. In sicker recipients, LT results in immediate survival, but poor medium-term survival rates in some studies. The scarcity of deceased donors obliges to maximize LT success. Alternative strategies, as living-donor LT, should be explored. LDLT has impressive results in Eastern centers, but it is restrained in Western countries, due to potential life-threatening complications in the donor.",[185,186,26,187],"Liver Diseases","Liver Cirrhosis","Liver Transplant; Complications","2025-10-15",{"date":139,"type":36},{"date":191,"type":36},"2021-07-08",{"date":193,"type":20},"2026-12-31",{"name":195,"class":43},"European Foundation for Study of Chronic Liver Failure",106,{"id":198,"slug":199,"hasResults":12,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":203,"eligibilityCriteria":204,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":205,"targetDuration":206,"studyType":132,"phases":4,"briefSummary":207,"conditions":208,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":232},"100450503","cytosorb-treatment-of-critically-ill-patients-registry-100450503","NCT05146336","CytOSorb TreatMent Of Critically Ill PatientS Registry","CytOSorb TreatMent Of Critically Ill PatientS Registry: International Registry on the Use of CytoSorb in the Critical Care Setting","COSMOS","Inclusion Criteria:\n\n1. Planned OR actual CytoSorb® 300 mL device utilization\n2. Informed consent for prospective registry participation\n\nExclusion Criteria:\n\n1. Use of the CytoSorb® 300 mL device for antithrombotic removal only\n2. Intraoperative use of CytoSorb® 300 mL device during cardiac surgery only\n3. The occurrence of a complication or other medically justified circumstance that arises after written informed consent has been obtained from the patient and before or during the planned therapy and as a result of which the use of CytoSorb® 300 mL Adsorber is contraindicated or no longer appropriate.",{"count":182,"type":20},"3 Months","Registry intended to provide a data repository and reporting infrastructure for the surveillance of CytoSorb device use in real-world critical care settings, and to serve as an objective, comprehensive, and scientifically-based resource to measure and improve the quality of patient care",[209,210,211,212,213,214,112,158,215,216,217,218,219,187,220,221,222,91],"Septic Shock","Acute Respiratory Distress Syndrome","Trauma","Rhabdomyolysis","Cardiogenic Shock","Pancreatitis","Burns","Chimeric Antigen Receptor T-Cell Therapy (CAR-T) Cytokine Release Syndrome (CRS)","Extracorporeal Life Support","Postoperative Endocarditis","Hemophagocytic Lymphohistiocytoses","Infectious Disease","Postoperative Vasoplegic Syndrome","Drug Overdose","2025-09-10",{"date":225,"type":36},"2025-09-11",{"date":227,"type":36},"2022-06-22",{"date":229,"type":20},"2032-09",{"name":231,"class":170},"CytoSorbents, Inc",28,{"id":234,"slug":235,"hasResults":12,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":239,"eligibilityCriteria":240,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":241,"enrollmentInfo":242,"targetDuration":4,"studyType":21,"phases":243,"briefSummary":245,"conditions":246,"keywords":247,"overallStatus":113,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":4},"100603055","phase-1-national-collaborative-centre-for-hepatic-regenerative-medicine-nc-chrm-phase-i-study-on-safety-and-efficacy-of-mesenchymal-stem-cell-msc-therapy-in-non-viral-acute-on-chronic-liver-failure-aclf-100603055","NCT07131540","National Collaborative Centre for Hepatic Regenerative Medicine (NC-CHRM): Phase I Study on Safety and Efficacy of Mesenchymal Stem-Cell (MSC) Therapy in Non-Viral Acute-on-Chronic Liver Failure (ACLF)","National Collaborative Centre for Hepatic Regenerative Medicine (NC-CHRM): To Study the Safety and Efficacy of Mesenchymal Stem-Cell Therapy in the Management of Non-viral ACLF Patients: Phase-I Clinical Study","NC-CHRM","Inclusion Criteria:\n\n* ACLF patients with Model for End-Stage Liver Disease (MELD) \\>18 or APASL ACLF Research Consortium (AARC) grade 2 or more with (no or single extrahepatic organ dysfunction or failure having no option of liver transplant).\n\nExclusion Criteria:\n\n* Age \\\u003C18 or \\>65 yrs\n* Patients with active sepsis\n* Patients with hepatic venous outflow tract obstruction (HVOTO) or Extrahepatic portal vein obstruction (EHPVO)\n* Hepatocellular carcinoma (beyond Milan) or any extrahepatic malignancy\n* Active bleed (mucosal or variceal) or severe coagulopathy (platelets \\\u003C20,000 or INR\\>4)\n* Patients with refractory shock requiring norepinephrine \\>0.5ug\u002Fkg\u002Fmin\n* Patients with severe Acute Respiratory Distress Syndrome (ARDS) with Pa02\u002FFi02 \\\u003C150\n* Patients with retroviral infections\n* Autoimmune hepatitis\n* Viral etiology of liver disease\n* Co-existent Hepatitis B, Hepatitis C, HIV\n* Chronic kidney disease\n* Multiorgan failure or disseminated intravascular coagulation (DIC)\n* Patients improving on standard medical treatment\n* Patients on immunosuppressive medications\n* Pregnancy or active breastfeeding\n* Known severe cardiopulmonary diseases (structural or valvular heart disease, coronary artery disease, coronary pulmonary disease, chronic kidney disease)\n* Lack of informed consent","65 Years",{"count":171,"type":20},[244],"PHASE1","Liver disease deaths are rising, but transplants remain scarce in India. With over 100,000 needed annually and only \\~2,500 performed, non-transplant options are urgently needed. Regenerative therapy, especially MSCs, shows promise but lacks validation, particularly for non-viral Acute on Chronic Liver Failure (ACLF). The proposed NC-CHRM aims to develop and validate MSC-based therapy to promote native liver regeneration and offer a safe, effective, transplant-free treatment.",[26],[248,249,250],"ACLF","MSC","Liver failure","2025-08-21",{"date":253,"type":36},"2025-08-28",{"date":255,"type":20},"2026-01",{"date":257,"type":20},"2031-12",{"name":122,"class":43},{"id":260,"slug":261,"hasResults":12,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":239,"eligibilityCriteria":265,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":241,"enrollmentInfo":266,"targetDuration":4,"studyType":21,"phases":268,"briefSummary":269,"conditions":270,"keywords":271,"overallStatus":113,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":44},"100603037","phase-2-national-collaborative-centre-for-hepatic-regenerative-medicine-nc-chrm-evaluating-mesenchymal-stem-cell-therapy-in-non-viral-acute-on-chronic-liver-failure-aclf-patient--phase-ii-trial-100603037","NCT07131306","National Collaborative Centre for Hepatic Regenerative Medicine (NC-CHRM): Evaluating Mesenchymal Stem Cell Therapy in Non-viral Acute on Chronic Liver Failure (ACLF) Patient- Phase-II Trial","National Collaborative Centre for Hepatic Regenerative Medicine (NC-CHRM): To Study the Safety and Efficacy of Mesenchymal Stem-Cell (MSC) Therapy in the Management of Non-viral ACLF Patients: Phase-II Clinical Study","Inclusion Criteria:\n\n* ACLF patients with Model for End-Stage Liver Disease(MELD)\\>18 or APASL ACLF Research Consortium(AARC) grade 2 or more with (no or single extrahepatic organ dysfunction or failure having no option of liver transplant).\n\nExclusion Criteria:\n\n* Age \\\u003C18 or \\>65 yrs\n* Patients with active sepsis\n* Patients with hepatic venous outflow tract obstruction (HVOTO) or Extrahepatic portal vein obstruction (EHPVO)\n* Hepatocellular carcinoma (beyond Milan) or any extrahepatic malignancy\n* Active bleed (mucosal or variceal) or severe coagulopathy (platelets \\\u003C20,000 or INR\\>4)\n* Patients with refractory shock requiring norepinephrine \\>0.5ug\u002Fkg\u002Fmin\n* Patients with severe Acute Respiratory Distress Syndrome (ARDS) with Pa02\u002FFi02 \\\u003C150\n* Patients with retroviral infections\n* Autoimmune hepatitis\n* Viral etiology of liver disease\n* Co-existent Hepatitis B, Hepatitis C, HIV\n* Chronic kidney disease\n* Multiorgan failure or Disseminated Intravascular Coagulation (DIC)\n* Patients improving on standard medical treatment\n* Patients on immunosuppressive medications\n* Pregnancy or active breastfeeding\n* Known severe cardiopulmonary diseases (structural or valvular heart disease, coronary artery disease, coronary pulmonary disease, chronic kidney disease)\n* Lack of informed consent",{"count":267,"type":20},100,[155],"Liver disease deaths are rising, but transplants remain scarce in India. With over 100,000 needed annually and only \\~2,500 performed, non-transplant options are urgently needed. Regenerative therapy, especially MSCs, shows promise but lacks validation, particularly for non-viral ACLF. The proposed NC-CHRM aims to develop and validate MSC-based therapy to promote native liver regeneration and offer a safe, effective, transplant-free treatment.",[26],[112,272,248,273],"Mesenchymal Stem Cells","Liver Regeneration","2025-08-19",{"date":276,"type":36},"2025-08-20",{"date":278,"type":20},"2027-01",{"date":280,"type":20},"2031-08",{"name":122,"class":43},{"id":283,"slug":284,"hasResults":12,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":239,"eligibilityCriteria":288,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":241,"enrollmentInfo":289,"targetDuration":4,"studyType":21,"phases":290,"briefSummary":292,"conditions":293,"keywords":294,"overallStatus":113,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":303,"locationsCount":304},"100598732","phase-3-national-collaborative-centre-for-hepatic-regenerative-medicine-nc-chrm-evaluating-mesenchymal-stem-cell-msc-therapy-in-non-viral-acute-on-chronic-liver-failure-aclf-patients---phase-iii-trial-100598732","NCT07075315","National Collaborative Centre for Hepatic Regenerative Medicine (NC-CHRM): Evaluating Mesenchymal Stem-Cell (MSC) Therapy in Non-viral Acute on Chronic Liver Failure (ACLF) Patients - Phase-III Trial","National Collaborative Centre for Hepatic Regenerative Medicine (NC-CHRM): To Study the Safety and Efficacy of Mesenchymal Stem-Cell Therapy in the Management of Non-viral ACLF Patients: Phase-III Clinical Study","Inclusion Criteria:\n\n* ACLF patients with Model for End-Stage Liver Disease (MELD) score \\>18 or APASL ACLF Research Consortium (AARC) grade 2 or more with (no or single extrahepatic organ dysfunction or failure having no option of liver transplant.\n\nExclusion Criteria:\n\n* Age \\\u003C18 or \\>65 yrs\n* Patients with active sepsis\n* Patients with Hepatic Venous Outflow Tract Obstruction(HVOTO) or Extrahepatic Portal Vein Obstruction (EHPVO)\n* Hepatocellular carcinoma (beyond Milan) or any extrahepatic malignancy\n* Active bleed (mucosal or variceal) or severe coagulopathy (platelets \\\u003C20,000 or INR\\>4)\n* Patients with refractory shock requiring norepinephrine \\>0.5ug\u002Fkg\u002Fmin\n* Patients with severe Acute Respiratory Distress Syndrome (ARDS) with Pa02\u002FFi02 \\\u003C150\n* Patients with retroviral infections\n* Autoimmune hepatitis\n* Viral etiology of liver disease\n* Co-existent Hepatitis B, Hepatitis C, HIV\n* Chronic kidney disease\n* Multiorgan failure or Disseminated Intravascular Coagulation\n* Pregnancy or active breastfeeding\n* Known severe cardiopulmonary diseases (structural or valvular heart disease, coronary artery disease, coronary pulmonary disease, chronic kidney disease)\n* Lack of informed consent",{"count":267,"type":20},[291],"PHASE3","Liver disease deaths are rising, but transplants remain scarce in India. With over 100,000 needed annually and only \\~2,500 performed, non-transplant options are urgently needed. Regenerative therapy, especially mesenchymal stem cells (MSCs), shows promise but lacks validation, particularly for non-viral ACLF. The proposed NC-CHRM aims to develop and validate MSC-based therapy to promote native liver regeneration and offer a safe, effective, transplant-free treatment.",[26],[295,248,296,239],"Acute on chronic Liver Failure","Mesenchymal Stem Cell","2025-08-12",{"date":299,"type":36},"2025-08-17",{"date":301,"type":20},"2028-01",{"date":257,"type":20},{"name":122,"class":43},3,{"id":306,"slug":307,"hasResults":12,"nctId":308,"briefTitle":309,"officialTitle":310,"acronym":311,"eligibilityCriteria":312,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":313,"enrollmentInfo":314,"targetDuration":4,"studyType":21,"phases":316,"briefSummary":317,"conditions":318,"keywords":321,"overallStatus":113,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":326,"startDateStruct":328,"completionDateStruct":330,"leadSponsor":331,"locationsCount":4},"100584492","phase-2-a-tango-phase-2-study-100584492","NCT06890039","A-TANGO Phase 2 Study","Phase II, Double-blind, Randomized, Placebo-controlled, Multicentre Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of TAK-242 and (G-CSF) in Subjects With (sAH) and (ACLF)","A-TANGO","Inclusion Criteria:\n\n* Patients accepted for inclusion into the study must meet all of the following criteria:\n\n  1. Male and female subjects ≥18 of age and ≤75 years of age\n  2. Compliance with acceptable contraceptive methods.\n  3. With a diagnosis of severe alcoholic hepatitis that is resistant to steroid therapy as defined by a Lille score of \\>0.45 and\u002For in whom steroids are contraindicated.\n  4. Eligible subjects will have Grade 1-3 ACLF with a maximum of three organ failures using the CLIF-C OF score AND the CLIF-C ACLF-CRP score of \\>35 and \\\u003C60.\n\nExclusion Criteria:\n\n* Patients with any of the following criteria are to be excluded:\n\n  * Refusal to give informed consent\n  * Mechanical ventilation due to respiratory failure and\u002For need for renal replacement therapy and or requiring inotropes for circulatory support with a noradrenaline requirement of \\>0.5ug\u002Fkg\u002Fmin to maintain mean arterial pressure \\> 70mmHg\n  * Subject has received any investigational drug within 30 days of randomization\n  * Subject has any of the following conditions:\n\n    * history of liver transplantation\n    * postoperative decompensation after partial hepatectomy\n    * liver failure without underlying chronic liver injury\n  * Any untreated infections (\\\u003C48h antibiotic therapy) including gram-positive infections, active tuberculosis or coinfection with HIV.\n  * Chronic or pre-existing kidney failure, survival prognosis of \\\u003C6 months due to severe co-morbid conditions that might confound study results or compromise subject safety\n  * Methemoglobinemia, clinically-significant disseminated intravascular coagulation, uncontrolled bleeding, sickle cell anemia\n  * Uncontrolled seizures, Creutzfeldt-Jakob disease, glucose-6-phosphate dehydrogenase deficiency.\n  * Active malignancy, premalignant hematological disorders (e.g., myelodysplastic syndrome, chronic myeloid leukemia) or multiorgan failure (≥ 4 organ failures).\n  * Pregnancy or nursing women\n  * Allergy to eggs","75 Years",{"count":315,"type":20},78,[155],"The purpose of this research is to know if a new combination of drugs (TAK-242 and G-CSF) in combination with standard therapy for acute-on-chronic liver failure (ACLF) is more effective than standard therapy for ACLF treatment and is safe.\n\nDescription of the population to be studied: ACLF is a syndrome that occurs in patients with chronic liver disease, with or without previously diagnosed cirrhosis, which is characterized by acute hepatic decompensation. Cirrhosis is a chronic disease of the liver marked by degeneration of cells, inflammation, and thickening and scarring (fibrosis) of liver tissue. Hepatic decompensation is a sudden decline in liver function. It is characterized by severe liver damage and complications like jaundice (yellowing of the skin or whites of the eyes), ascites (a condition where excess fluid accumulates in the abdominal cavity and in abdominal organs) and encephalopathy (a group of symptoms that result from damage or dysfunction in the brain, causing a range of cognitive and neurological impairments). It may result in liver failure, one or more organ failures other than liver (renal, brain, coagulation, respiratory, cardiovascular), and is associated with increased mortality within 28-days and up to 3 months from onset. Grade 1 ACLF has a \\>15% risk of mortality at 28 days.\n\nPurpose of the study: The investigational medication, TAK-242, is aimed at stopping an \"over-reaction\" of the immune system (the body's defense system) while G-CSF encourages your liver cells to grow. In patients with severe inflammation of the liver due to alcohol \\[severe alcoholic hepatitis (sAH)\\] and ACLF, this over-reaction may cause the liver and other organs in the body to suddenly stop working (organ failure). The hypothesis of the study is that by blocking this over-reaction and encouraging your liver cells to grow your condition may improve.",[26,319,320],"Alcoholic Hepatitis","Liver Cirrhosis, Alcoholic",[322,323,248,324],"Novel combinatorial therapy","Improve hepatocyte proliferation","Liver disease","2025-07-23",{"date":327,"type":36},"2025-07-29",{"date":329,"type":20},"2025-09-01",{"date":193,"type":20},{"name":332,"class":170},"Yaqrit Ltd",{"id":334,"slug":335,"hasResults":12,"nctId":336,"briefTitle":337,"officialTitle":338,"acronym":4,"eligibilityCriteria":339,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":313,"enrollmentInfo":340,"targetDuration":4,"studyType":21,"phases":342,"briefSummary":343,"conditions":344,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":44},"100579997","comparison-of-blood-products-required-using-two-different-rotem-cut-offs-before-invasive-procedures-in-cirrhosis-and-acute-on-chronic-liver-failure-aclf-patients-with-severe-coagulopathy-100579997","NCT06831565","Comparison of Blood Products Required Using Two Different ROTEM Cut-offs Before Invasive Procedures in Cirrhosis and Acute on Chronic Liver Failure (ACLF) Patients With Severe Coagulopathy","Comparison of Blood Products Required Using Two Different ROTEM Cut-offs Before Invasive Procedures in Cirrhosis and Acute on Chronic Liver Failure (ACLF) Patients With Severe Coagulopathy: A Randomized Controlled Trial","Inclusion Criteria:\n\n1. Cirrhosis and ACLF ( as per definition)\n2. Planned to undergo invasive procedures\n3. Severe Coagulopathy- INR\\>2.0 or Platelets \\\u003C30k or Fibrinogen\\\u003C100mg\u002Fdl .\n\nExclusion Criteria:\n\n1. Ongoing bleeding\n2. Bleeding in past 48 hours before procedure\n3. Antiplatelet or anticoagulant therapy ( stopped \\\u003C 7 days before)",{"count":341,"type":20},934,[23],"Coagulation system in cirrhotics patients is a fragile state , which is rebalanced hemostasis. Standard tests (INR\u002FaPTT) stop measuring at first stage of coagulation ,when the clot first form. VETs measure the whole process such as ROTEM, TEG and comparing these two tests to assess for transfusion of blood products for invasive procedures. . ROTEM provides information both on anti coagulant and procoagulant status where as conventional tests provide only anti coagulant status Invasive procedures can be low risk or high risk or Non surgical vs surgical, Procedure related bleed occurs in 7% of patients with cirrhosis and associated with higher 28 day mortality. MELD, CTP ,AKI , SEPSIS increase the risk of procedure related bleed. Hence for invasive procedures investigator is using relaxing threshold for blood product transfusion in cirrhosis, ACLF patients. As use of ROTEM when compared to conventional tests reduces the need for blood transfusion. Investigator want to proceed with further relaxation of cutoff values of Coagulation parameters and use High cutoff vs low cut off for blood transfusion need.",[26],"2025-06-27",{"date":347,"type":36},"2025-07-01",{"date":349,"type":36},"2025-03-19",{"date":351,"type":20},"2026-02-28",{"name":122,"class":43},{"id":354,"slug":355,"hasResults":12,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":4,"eligibilityCriteria":359,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":241,"enrollmentInfo":360,"targetDuration":4,"studyType":21,"phases":361,"briefSummary":362,"conditions":363,"keywords":365,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":370,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":374,"locationsCount":44},"100495172","phase-1-micro-encapsulated-hepatocyte-intraperitoneal-transplantation-in-liver-failure-adults-100495172","NCT05727722","Micro-encapsulated Hepatocyte Intraperitoneal Transplantation in Liver Failure Adults","A Phase I Safety and Tolerability Dose Escalation Study of Micro-encapsulated Hepatocytes Intraperitoneal Transplantation Therapy for Adult Liver Failure Patients.","Inclusion Criteria:\n\nA. Chronic liver failure (CLF) group:\n\nThe progressive liver function decline or decompensation after liver cirrhosis:\n\n1. Body weight\\>40kg;\n2. Aged between 18 to 65 years old;\n3. Serum Total bilirubin was higher than the normal range and lower than 10 times the upper limit of normal value (ULN);\n4. With or without significantly decreased serum albumin value, lower than 35;\n5. With or without significantly decreased platelet (PLT) value, prothrombin activity (PTA)≤40% (or international normalized ratio (INR)≥1.5), other reasons excluded;\n6. With or without refractory ascites or portal hypertension;\n7. With or without a stage I or II hepatic encephalopathy;\n8. No obvious improvement after more than 3 days' regular clinical treatments.\n\nOR B. Acute-on-chronic liver failure (ACLF) group:\n\nWith known or unknown basic liver diseases, subjects undergoing acute liver failure syndrome (clinical manifestations indicated as an early stage liver failure).\n\n1. Body weight\\>40kg;\n2. Aged between 18 to 65 years old;\n3. With obvious fatigue, accompanied by other gastrointestinal symptoms such as anorexia, vomiting, and abdominal distension;\n4. Complicated with ascites and\u002For hepatic encephalopathy within 4 weeks after being diagnosed;\n5. Progressive aggravation of jaundice, total serum bilirubin≥85umol\u002FL；\n6. Coagulation disorders, INR\\>1.5 or PTA\\\u003C40%;\n7. No obvious improvement after more than 3 days' regular clinical treatments.\n\nExclusion Criteria:\n\n1. With obvious brain edema, cerebral hernia, or indicated intracranial hemorrhage;\n2. Diagnosed or suspected as primary or metastatic liver cancer;\n3. With uncorrectable oxygenation index (PaO2\u002FFiO2)\\\u003C200;\n4. With disseminated intravascular coagulation;\n5. Active hemorrhage;\n6. Uncontrollable infection, including ascites infection such as spontaneous bacterial peritonitis;\n7. Uncorrectable decrease in PLT (\\\u003C20×109\u002FL);\n8. HIV and\u002For SARS-CoV-Ⅱ positive;\n9. Drug abuse within 1 year;\n10. Systemic hemodynamic instability;\n11. Combined with pregnancy or lactation;\n12. Other situations excluded by clinician;",{"count":171,"type":20},[244],"This is a prospective single-center dose escalation study of the administration of the microencapsulated hepatocyte therapy in adult liver failure. The purpose of the study is to determine the maximum tolerated dose of microencapsulated hepatocytes in liver failure patients and its effectiveness in treating the disease. We previously generated proliferating human hepatocytes (ProliHH) through dedifferentiation of PHH and engineered them into encapsulated liver organoids (eLO), providing an unlimited cell source for hepatocyte transplantation.",[26,364],"Chronic Liver Failure",[26,364,366,367,368],"cell transplantation","hepatocyte transplantation","micro-encapsulate","2025-06-23",{"date":345,"type":36},{"date":372,"type":36},"2024-03-01",{"date":351,"type":20},{"name":375,"class":43},"RenJi Hospital",{"id":377,"slug":378,"hasResults":12,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":4,"eligibilityCriteria":382,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":313,"enrollmentInfo":383,"targetDuration":4,"studyType":21,"phases":385,"briefSummary":386,"conditions":387,"keywords":4,"overallStatus":113,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":389,"startDateStruct":391,"completionDateStruct":393,"leadSponsor":394,"locationsCount":4},"100586531","phase-2-chinese-phase-ii-trail-of-as1501-in-acute-on-chronic-liver-failure-aclf-patients-100586531","NCT06916585","Chinese Phase II Trail of AS1501 in Acute-on-chronic Liver Failure (ACLF) Patients","A Phase II Clinical Trial to Evaluate the Safety and Efficacy of Injectable AS1501 in the Treatment of Acute-on-chronic Liver Failure (ACLF)","Inclusion Criteria:\n\n* The age range for signing the informed consent form is between 18 and 75 years old\n* According to the \"Diagnosis and Treatment Guidelines for Liver Failure (2018 Edition)\" issued by the Liver Failure and Artificial Liver Group of the Infectious Diseases Branch of the Chinese Medical Association and the Severe Liver Disease and Artificial Liver Group of the Hepatology Branch of the Chinese Medical Association, it has been diagnosed with chronic acute liver failure, with specific indicators including:\n\n  1. Patients with chronic liver disease (chronic hepatitis B, autoimmune hepatitis, drug-induced hepatitis, etc.) and the acute attack factor is drugs;\n  2. Serum TBil ≥ 10 × ULN or average daily increase ≥ 17.1 μ mol\u002FL;\n  3. Meet any of the following three criteria: A has a tendency to bleed, PTA ≤ 40% (or INR ≥ 1.5); B combined with hepatic encephalopathy; C combined with hepatorenal syndrome or ascites.\n* Screening was conducted in the early stage of liver failure and did not meet the criteria for liver transplantation;\n* Early manifestations of liver failure:\n\nExtreme fatigue, accompanied by severe gastrointestinal symptoms such as anorexia, vomiting, and bloating; ALT and\u002For AST continue to significantly increase, and jaundice progressively deepens (TBil\\>171 μ mol\u002FL or daily increase\\>17.1 μ mol\u002FL); There is a tendency for bleeding, with 30%\\\u003CPTA ≤ 40% (or 1.5 ≤ INR\\\u003C1.9); No complications or other extrahepatic organ failure.\n\n* During the screening period, serum TRAIL levels increased and were ≥ 3 times higher than normal human TRAIL levels;\n* Can understand the informed consent form, voluntarily participate and sign the informed consent form;\n* Capable of completing experiments in accordance with the research protocol;\n* The subjects (including partners) are willing to voluntarily adopt effective contraceptive measures within 6 months after the last administration of the investigational drug.\n\nExclusion Criteria:\n\n* Patients with a history of allergies or severe allergies to protein drugs (CTCAE v5.0 score\\>grade 3);\n* Patients who have completed liver transplantation or plan to undergo liver transplantation within one month.\n* ACLF patients in the middle and late stages; Severe grade III ascites or refractory ascites accompanied by stage III-IV hepatic encephalopathy.\n* Individuals who have received artificial liver treatment within one week prior to screening.\n* Individuals with malignant tumors or a history of malignant tumors in the past; Patients with lung cancer, liver cancer, pancreatic cancer, gastrointestinal tract and other tumors were diagnosed by imaging (ultrasound, CT or MRI) and tumor markers (AFP, CEA, CA125 or CA199, etc.) during the screening period or within one month before the screening period.\n* Individuals who have undergone gastroscopy or imaging (abdominal B-ultrasound, CT, or MRI) during the screening period or within one month prior to screening, and whose results indicate a risk of severe varicose veins with bleeding.\n* Subjects with acute kidney injury (AKI) defined by KDIGO criteria: (1) Scr elevation ≥ 26.5 μ mol\u002FL (0.3mg\u002FdL, 1mg\u002FdL=88.4 μ mol\u002FL) within 48 hours; (2) Scr increases by 1.5 times or more than the baseline value within 7 days; (3) Decreased urine output (\\\u003C0.5ml\u002Fkg\u002Fh) and lasting for more than 6 hours.\n* There are the following laboratory test values or abnormal test values: a. Blood routine: platelet count (PLT)\\\u003C75 × 109\u002FL, hemoglobin (HGB)\\\u003C80g\u002FL; b. PT-INR\\>1.9 or PTA\\\u003C30%; c. Left ventricular ejection fraction (LVEF)\\\u003C50%; Blood creatinine\\>1.5 × ULN.\n* Patients with severe respiratory dysfunction, difficulty breathing, or failure.\n* Severe infections that cannot be controlled by concomitant medications, including infections of major organs such as the abdominal cavity, lungs, urinary tract, and skin.\n* HIV positive individuals, or active tuberculosis or syphilis infected individuals.\n* Individuals with a history of unstable ischemic heart disease, congestive heart failure, myocardial infarction, stroke, severe arrhythmia, etc.\n* Subjects with uncontrolled severe hypertension or diabetes.\n* Pregnant or lactating women, or those who test positive for pregnancy.\n* Participants in clinical trials of other drugs or medical devices within 30 days prior to randomization or within five drug half lives.\n* Having undergone trauma or major surgery (e.g. requiring general anesthesia) within 28 days prior to the first administration of the investigational drug. Note: Participants who plan to undergo surgical procedures under local anesthesia are eligible to participate in the study.\n* Any serious underlying medical or mental condition (such as alcohol or drug abuse), dementia, or change in mental state; Or any issues that may impair the subject's ability to receive or tolerate planned treatment at the research center, understand informed consent, or issues that the researcher deems taboo to participate in the study or confound the evaluation or study results specified in the protocol.\n* Researchers believe that other conditions are not suitable for participating in this study.",{"count":384,"type":20},96,[155],"\\*\\*Document Name: This Trial is a Phase II Clinical Study.docx\\*\\* \\*\\*Document Content:\\*\\*\n\n* This trial is a Phase II clinical study, conducted in two stages:\n* \\*\\*Phase IIa:\\*\\* A sentinel, single-arm design will be employed. A total of 12 early ACLF subjects are expected to be enrolled in the 0.5 mg\u002Fkg dose group. The first 2 subjects will serve as sentinels and be enrolled sequentially to receive a single intravenous dose. If no drug-related SAEs (Serious Adverse Events) occur in these 2 sentinel subjects within 2 weeks after the first dose, the remaining 10 subjects will be enrolled. Otherwise, the dose will be reduced for further exploration. After receiving a single intravenous dose, subjects will undergo a 20-day washout period. If no drug-related ≥Grade 3 AEs (Adverse Events) occur during this 20-day washout period, and safety\u002Ftolerability is jointly confirmed by the investigator and sponsor, the subject will enter the multiple-dose phase (once weekly \\[Day 21 as the first dose of multiple administration\\], for 4 consecutive weeks). If any drug-related ≥Grade 3 AE occurs, the dose will be reduced for further exploration, with the specific dose determined by the sponsor and investigator. If a subject drops out during the washout period after a single dose, additional subjects may be enrolled to ensure at least 12 subjects enter the multiple-dose phase.\n* After all 12 early ACLF subjects in the 0.5 mg\u002Fkg dose group complete continuous dosing, the DMC (Data Monitoring Committee) will assess the safety of this dose group. If any of the following occur in the 0.5 mg\u002Fkg group, the DMC will discuss whether to proceed with dose escalation:\n\n\\> 1) ≥1\u002F3 of subjects experience drug-related Grade 3 SAEs; \\> 2) Any drug-related Grade 4 or higher SAEs.\n\n* If the DMC determines that dose escalation criteria are met, an additional 12 early ACLF subjects will be enrolled to receive the 1 mg\u002Fkg dose group. The same enrollment rules as the 0.5 mg\u002Fkg group apply: the first 2 subjects are sentinels receiving a single intravenous dose. If no drug-related SAEs occur in these sentinels within 2 weeks post-dose, the remaining 10 subjects will be enrolled. Post-single-dose administration, subjects will undergo a 20-day washout period. If no drug-related ≥Grade 3 AEs occur during this period, and safety\u002Ftolerability is confirmed, subjects will enter the multiple-dose phase (once weekly \\[Day 21 as the first dose\\], for 4 consecutive weeks). Dropouts during the washout period may be replaced to ensure at least 12 subjects enter the multiple-dose phase.\n* After completing the 0.5 mg\u002Fkg and 1 mg\u002Fkg dose exploration studies, the investigator and sponsor may determine the recommended dose for Phase IIb based on cumulative safety, efficacy, and potential PK\u002FPD results. Additional dose groups or alternative administration frequencies may also be explored.\n* \\*\\*Phase IIb:\\*\\* A randomized (1:1), double-blind, placebo-controlled design will be used. A total of 72 ACLF subjects are expected to receive either AS1501 at the appropriate dose\u002Ffrequency or placebo to further evaluate the efficacy and safety of AS1501 injection. The specific design will be finalized based on Phase IIa results and agreed upon by the investigator and sponsor.",[26],"2025-04-07",{"date":390,"type":36},"2025-04-09",{"date":392,"type":20},"2025-04-15",{"date":75,"type":20},{"name":395,"class":43},"Shenzhen Third People's Hospital",{"id":397,"slug":398,"hasResults":12,"nctId":399,"briefTitle":400,"officialTitle":401,"acronym":402,"eligibilityCriteria":403,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":85,"enrollmentInfo":404,"targetDuration":4,"studyType":21,"phases":405,"briefSummary":406,"conditions":407,"keywords":408,"overallStatus":113,"whyStopped":4,"lastUpdateSubmitDate":411,"lastUpdatePostDateStruct":412,"startDateStruct":413,"completionDateStruct":414,"leadSponsor":416,"locationsCount":4},"100584097","phase-2-umbilical-cord-derived-mesenchymal-stem-cell-infusion-for-treating-aclf-100584097","NCT06884904","Umbilical Cord-derived Mesenchymal Stem Cell Infusion for Treating ACLF","Umbilical Mesenchymal Stem Cells in the Treatment of Acute-on-Chronic Liver Failure：A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase IIb\u002FIII Seamless Adaptive Design Clinical Study","MSCTACLF","Inclusion Criteria:\n\n1. Age between 18 and 70 years (inclusive) at the time of signing the informed consent form, regardless of gender.\n2. Patients with hepatitis B virus (HBV)-associated acute-on-chronic liver failure (ACLF) meeting the following criteria: Total bilirubin (TBil) ≥12 mg\u002FdL (equivalent to 205 μmol\u002FL); International normalized ratio (INR) ≥1.5 or prothrombin activity (PTA) ≤40%;\n3. All participants and their partners agree to use effective non-pharmacological contraception during the trial and for 6 months after trial completion, with no plans for conception during this period.\n4. Voluntarily participate in the clinical study and sign the informed consent form.\n\nExclusion Criteria:\n\n1. History of allergy to any component of the investigational drug or bovine-derived products.\n2. Acute, subacute, or chronic liver failure unrelated to HBV, or ACLF caused by: Concurrent hepatitis A, C, or E virus infection; Autoimmune liver disease; Biliary obstruction.\n3. Presence of any of the following complications: \\\u003C1\\> Active gastrointestinal bleeding (e.g., hematemesis and\u002For melena) or high- risk esophageal\u002Fgastric varices (confirmed by endoscopy or imaging within 3 months prior to screening). \\\u003C2\\> Imaging evidence (ultrasound or CT) of cavernous transformation of the portal vein or portal vein occlusion. \\\u003C3\\> History of transjugular intrahepatic portosystemic shunt (TIPS). \\\u003C4\\> Grade 3 or 4 hepatic encephalopathy. \\\u003C5\\> Serum creatinine ≥2 mg\u002FdL. \\\u003C6\\> Respiratory insufficiency (e.g., dyspnea, cyanosis) with peripheral oxygen saturation ≤93% at rest.\n4. Severe underlying diseases, including: \\\u003C1\\>Septic shock (requiring vasopressors to maintain mean arterial pressure ≥65 mmHg despite adequate fluid resuscitation, with blood lactate \\>2 mmol\u002FL). \\\u003C2\\> Uncontrolled cardiac conditions: Myocardial ischemia or infarction (CTCAE v5.0 Grade ≥II), Arrhythmias requiring intervention, NYHA Class III-IV heart failure. \\\u003C3\\> Active malignancy (solid or hematologic). \\\u003C4\\> Diagnosed pulmonary hypertension or suspected pulmonary embolism. \\\u003C5\\> IgA deficiency, Henoch-Schönlein purpura, hemophilia, or idiopathic thrombocytopenia. \\\u003C6\\> Immunodeficiency disorders (e.g., HIV infection, congenital\u002Facquired immune deficiency).\n5. Current systemic corticosteroid therapy for other diseases.\n6. Psychiatric or other conditions deemed by the investigator to interfere with study assessments.\n7. Planned or active registration for liver transplantation, or anticipated transplantation within 3 months.\n8. History of liver transplantation.\n9. Alcohol or substance abuse: Chronic alcohol use (\\>5 years with ethanol intake ≥40 g\u002Fday for males or ≥20 g\u002Fday for females), Heavy alcohol use (\\>80 g\u002Fday ethanol) within 2 weeks prior to screening, Abstinence \\\u003C6 months.\n10. Participation in another clinical trial within 3 months prior to screening (excluding screen failures or withdrawal before dosing).\n11. Pregnancy, lactation, or positive pregnancy test at screening.\n12. Any other condition that, in the investigator's judgment, may confound study results, pose risks, or compromise the participant's best interests.",{"count":384,"type":20},[155,291],"This study is a multicenter, randomized, double-blind, placebo-controlled adaptive design Phase IIb\u002FIII clinical trial. It employs a seamless adaptive design, divided into Phase IIb and Phase III, focusing on patients with acute-on-chronic liver failure (ACLF). Eligible patients meeting the inclusion criteria and not disqualified were randomized in a 2:2:1:1 ratio during Phase IIb to receive either a high-dose experimental group (4.0×10\\^6\u002Fkg of injectable mesenchymal stem cells derived from umbilical cord), a low-dose group (2.0×10\\^6\u002Fkg), a high-dose placebo control group (with equivalent volume of solvent calculated at 4.0×10\\^6\u002Fkg), or a low-dose placebo control group (with equivalent volume of solvent calculated at 2.0×10\\^6\u002Fkg). In Phase III, patients were randomized in a 1:1 ratio to the experimental group (injectable umbilical cord-derived mesenchymal stem cells) or the control group. All groups received standard treatment alongside either the experimental drug (experimental group) or placebo (control group) to evaluate and confirm the efficacy and safety of injectable umbilical cord-derived mesenchymal stem cells in treating acute-on-chronic liver failure.",[26],[409,410],"acute-on-chronic liver failure","mesenchymal stem cells","2025-03-13",{"date":349,"type":36},{"date":392,"type":20},{"date":415,"type":20},"2028-04-14",{"name":417,"class":43},"National Engineering Center of Cell Products",{"id":419,"slug":420,"hasResults":12,"nctId":421,"briefTitle":422,"officialTitle":422,"acronym":4,"eligibilityCriteria":423,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":424,"targetDuration":4,"studyType":21,"phases":426,"briefSummary":427,"conditions":428,"keywords":4,"overallStatus":113,"whyStopped":4,"lastUpdateSubmitDate":429,"lastUpdatePostDateStruct":430,"startDateStruct":432,"completionDateStruct":433,"leadSponsor":434,"locationsCount":44},"100578997","comparison-of-efficacy-and-safety-of-ceftazidime-avibactam-versus-extended-infusions-of-high-dose-meropenem-in-patients-of-aclf-with-nosocomial-infections-100578997","NCT06818565","Comparison of Efficacy and Safety of Ceftazidime Avibactam Versus Extended Infusions of High Dose Meropenem in Patients of ACLF With Nosocomial Infections.","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. ACLF as per APASL criteria\n3. ACLF patients with nosocomial infections caused by carbapenem resistant organism (defined as suspected or documented evidence of infection after 48 hours of hospitalization) requiring antibiotics.\n\nExclusion Criteria:\n\n1. Severe septic shock with MOF requiring escalation of antibiotics\n2. Patients having known allergies to meropenem or Ceftazidime Avibactam\n3. Culture sensitivity showing isolate non susceptible to study drug being investigated.\n4. Already on either regimen, receiving meropenem or Ceftazidime Avibactam \\>48 hours.\n5. On mechanical ventilator support PF ratio \\\u003C 300.\n6. Patients on immunosuppression medication\n7. HCC or other malignancies\n8. CKD\n9. CAD\n10. Pregnancy or Lactation\n11. Post Liver Transplantation\n12. Refusal to consent\n13. PLWHA",{"count":425,"type":20},150,[23],"Acute on chronic liver failure patients are at high risk for nosocomial infections due to liver dysfunction, which impairs immune responses and increases vulnerability to infections. Key factors contributing to nosocomial infections in ACLF patients include ascites, use of invasive devices, and recent hospitalization, frequent need for broad spectrum antibiotics. Multidrug resistance is a growing issue, making treatment more challenging, common pathogens involved are gram negative bacteria such as Escherichia Coli and Klebsiella pneumoniae. Surveillance data show increasing carbapenem resistant enterobacterales (CRE) infection rates in cirrhotics, with high morbidity and mortality rates. The impact of these nosocomial infections is profound, significantly worsen outcomes in ACLF patients, leading to prolonged hospitalizations, increased health care costs and higher mortality rates. Early detection and effective antibiotic stewardship are essential to manage antibiotic resistance and improve patient outcomes. In this study we aim to compare efficacy and safety of Ceftazidime avibactam versus extended infusions of high dose Meropenem in patients of ACLF with nosocomial infections.",[26],"2025-02-07",{"date":431,"type":36},"2025-02-10",{"date":431,"type":20},{"date":193,"type":20},{"name":122,"class":43},{"id":436,"slug":437,"hasResults":12,"nctId":438,"briefTitle":439,"officialTitle":440,"acronym":4,"eligibilityCriteria":441,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":442,"targetDuration":4,"studyType":21,"phases":444,"briefSummary":445,"conditions":446,"keywords":4,"overallStatus":113,"whyStopped":4,"lastUpdateSubmitDate":447,"lastUpdatePostDateStruct":448,"startDateStruct":449,"completionDateStruct":450,"leadSponsor":451,"locationsCount":44},"100578782","phase-2-efficacy-and-safety-of-continuous-infusion-of-terlipressin-vs-bolus-terlipressin-in-aclf-patients-with-acute-esophageal-variceal-bleed-100578782","NCT06815770","Efficacy and Safety of Continuous Infusion of Terlipressin vs Bolus Terlipressin in ACLF Patients With Acute Esophageal Variceal Bleed","Efficacy and Safety of Continuous Infusion of Terlipressin vs Bolus Terlipressin in ACLF Patients With Acute Esophageal Variceal Bleed: Pilot Study","Inclusion Criteria:\n\n1. Adult patients (age ≥ 18 years) diagnosed with ACLF presenting with due to esophageal varices bleeding.\n\nExclusion Criteria:\n\n1. Age \\\u003C 18 years\n2. History of coronary heart disease or ventricular arrhythmia,\n3. Stroke or transient ischemic attack,\n4. Bronchial asthma,\n5. Epilepsy,\n6. Pregnancy,\n7. Rebleeding.\n8. HCC\n9. Gastric variceal bleed",{"count":443,"type":20},60,[155,291],"Acute portal hypertension, as measured by rapid rise in hepatic venous pressure gradient (HVPG) can lead to further dreaded complications, including acute variceal bleeding (AVB) AVB: 6-week mortality rates of around 15-20% in patients with chronic liver disease without ACLF.The overall prevalence of UGH in cirrhotic patients with AD was 34.4% and 35.7% in patients with ACLF.AVB is a well-recognized precipitant leading to the occurrence and development of ACLF. AVB is a well-recognized precipitant leading to the occurrence and development of ACLF. Medical therapy for esophageal variceal bleeding (EVB) aims to reduce the splanchnic blood flow and portal pressure. The most common vasoactive agents include terlipressin, vasopressin, somatostatin, and octreotide.",[112],"2025-02-06",{"date":429,"type":36},{"date":431,"type":20},{"date":351,"type":20},{"name":122,"class":43},{"id":453,"slug":454,"hasResults":12,"nctId":455,"briefTitle":456,"officialTitle":457,"acronym":4,"eligibilityCriteria":458,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":85,"enrollmentInfo":459,"targetDuration":4,"studyType":21,"phases":461,"briefSummary":462,"conditions":463,"keywords":4,"overallStatus":113,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":465,"startDateStruct":467,"completionDateStruct":469,"leadSponsor":470,"locationsCount":44},"100578185","goal-directed-ammonia-lowering-therapy-in-hyperammonemic-aclf-patients-with-no-overt-he-to-reduce-major-adverse-liver-related-outcomes-goal-trial-100578185","NCT06808009","Goal Directed Ammonia Lowering Therapy in Hyperammonemic ACLF Patients With no Overt HE to Reduce Major Adverse Liver Related Outcomes (GOAL Trial)","Goal Directed Ammonia Lowering Therapy in Hyperammonemic ACLF Patients With no Overt HE to Reduce Major Adverse Liver Related Outcomes (GOAL Trial)- A Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age 18-70 years\n2. ACLF as per APASL criteria (AARC grade I\u002FII)\n3. Baseline ammonia levels of ≥135ug\u002Fdl or 79.5umol\u002Fl\n4. Given informed consent\n\nExclusion Criteria:\n\n* 1\\. Overt HE 2. AARC grade III 3. Confirmed or suspected bacterial infection 4. Extrahepatic organ failure 5. Renal dysfunction lasting for more than 48 hours or need for vasoconstrictors 6. Paralytic ileus 7. Patients with hepatocellular carcinoma beyond Milan criteria or any other neoplastic disorder 8. Pregnant and lactating women 9. Use of lactulose, rifaximin or LOLA in past 48h 10. Uncontrolled DM, HT, CAD 11. Patients with allergy or other contraindications of the used drugs",{"count":460,"type":20},90,[23],"SIRS in ACLF exacerbate adverse effects of ammonia - sarcopenia, infections, immune dysfunction, HE and organ dysfunction Persistent or incident hyperammonemia during first week of hospitalization in patients with ACLF is associated with increased risk of organ failure and death. Prospective studies on the efficacy of ammonia lowering therapies on major adverse liver related outcomes (MALO) (any of AARC III, bacterial infection, overt HE grade or death) in hyperammonemic ACLF patients with no overt HE are limited. In this study we aim to to compare the safety and efficacy of ammonia lowering therapy (goal directed lactulose and rifaximin) compared to SMT to prevent major liver related outcomes (MALO) (any of AARC III, bacterial infection, overt HE grade or death) in hyperammonemic ACLF patients with no overt HE.",[112],"2025-02-03",{"date":466,"type":36},"2025-02-04",{"date":468,"type":20},"2025-02-05",{"date":351,"type":20},{"name":122,"class":43},{"id":472,"slug":473,"hasResults":12,"nctId":474,"briefTitle":475,"officialTitle":476,"acronym":4,"eligibilityCriteria":477,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":241,"enrollmentInfo":478,"targetDuration":4,"studyType":132,"phases":4,"briefSummary":480,"conditions":481,"keywords":483,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":487,"lastUpdatePostDateStruct":488,"startDateStruct":490,"completionDateStruct":492,"leadSponsor":494,"locationsCount":44},"100408337","combination-of-dpmas-and-low-volume-pe-for-patients-with-hbv-related-aclf-100408337","NCT04597164","Combination of DPMAS and Low Volume PE for Patients With HBV Related ACLF","Double Plasma Molecular Adsorption System With Sequential Low-Dose Plasma Exchange in Patients With Hepatitis B Virus-Related Acute-on-Chronic Liver Failure: A Prospective Cohort Study","Inclusion Criteria:\n\n1. Clinical diagnosis of chronic hepatitis b virus infection (positive hepatitis b surface antigen or positive hepatitis b virus DNA \\> 0.5 year);\n2. Age from 18 to 65 years old;\n3. Clinical diagnosis of liver failure (serum total bilirubin level \\> 10 times upper limit of normal; prothrombin time activity \\\u003C 40% and ≥20%, or prothrombin time international ratio ≤ 2.6 and \\> 1.5);\n4. Platelets \\> 50\\*10 E9\u002FL.\n\nExclusion Criteria:\n\n1. Other active liver diseases;\n2. Hepatocellular carcinoma or 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;\n6. Other important organ dysfunctions or transplantation;\n7. Severe complications including severe infection, gastrointestinal bleeding, hepatic encephalopathy, hepatorenal syndrome;\n8. Patients can not follow-up;\n9. Investigator considering inappropriate.",{"count":479,"type":20},200,"This study is to investigate investigate the safety and efficacy of Double plasma molecular adsorption system with sequential low-dose plasma exchange in treating hepatitis B virus-related acute-on-chronic liver failure.",[482,26],"Hepatitis B, Chronic",[484,409,485,486],"hepatitis b virus","double plasma molecular adsorption system","plasma exchange","2024-11-26",{"date":489,"type":36},"2024-11-29",{"date":491,"type":36},"2020-12-22",{"date":493,"type":20},"2024-12-31",{"name":99,"class":43},{"id":496,"slug":497,"hasResults":12,"nctId":498,"briefTitle":499,"officialTitle":500,"acronym":4,"eligibilityCriteria":501,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":241,"enrollmentInfo":502,"targetDuration":4,"studyType":132,"phases":4,"briefSummary":504,"conditions":505,"keywords":507,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":487,"lastUpdatePostDateStruct":509,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":513,"locationsCount":44},"100386365","long-term-prognosis-of-patients-with-hepatitis-b-related-acute-on-chronic-liver-failure-100386365","NCT04310787","Long-term Prognosis of Patients With Hepatitis B Related Acute-on-chronic Liver Failure","The Investigation on Long-term Outcomes and Prognostic Factors of Patients With Hepatitis B Related Acute-on-chronic Liver Failure","Inclusion Criteria:\n\n* Age from 18 to 65 years old;\n* The diagnosis consistent with hepatitis b associated chronic acute liver failure；\n* After hospitalization, the survival time \\> 90 days；\n* The inpatient clinical data are complete.\n\nExclusion Criteria:\n\n* Human immunodeficiency virus infection or congenital immune deficiency diseases;\n* Liver cancer and other tumors, autoimmune liver disease, genetic and metabolic liver disease, or other serious diseases that significantly affect patient survival;\n* Other conditions that the researchers judged not appropriate for inclusion.",{"count":503,"type":20},300,"This study is to investigate the long-term outcomes and prognostic risk factors in patients recovered from hepatitis B virus related acute on-chronic liver failure.",[506,26],"Hepatitis B",[506,26,508],"Prognosis",{"date":489,"type":36},{"date":511,"type":36},"2020-05-15",{"date":493,"type":20},{"name":99,"class":43},{"id":515,"slug":516,"hasResults":12,"nctId":517,"briefTitle":518,"officialTitle":519,"acronym":520,"eligibilityCriteria":521,"healthyVolunteers":12,"sex":16,"minAge":522,"maxAge":241,"enrollmentInfo":523,"targetDuration":4,"studyType":21,"phases":524,"briefSummary":525,"conditions":526,"keywords":527,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":487,"lastUpdatePostDateStruct":530,"startDateStruct":531,"completionDateStruct":533,"leadSponsor":534,"locationsCount":44},"100356408","three-types-of-nucleotidenucleoside-analogues-treatment-in-hbv-related-aclf-100356408","NCT03920618","Three Types of Nucleotide\u002FNucleoside Analogues Treatment in HBV Related ACLF","Study on Three Types of Nucleotide\u002FNucleoside Analogues Treatment in Patients With Hepatitis b Virus Related Acute-on-chronic Liver Failure","HBV","Inclusion Criteria:\n\n1. Positive hepatitis b surface antigen or hepatitis b virus DNA \\> 0.5 year;\n2. Age from 12 to 65 years old;\n3. Serum total bilirubin level \\> 10 times upper limit of normal;\n4. Prothrombin time activity \\\u003C 40% or prothrombin time international ratio \\> 1.5；\n5. Do not receive nucleotide\u002Fnucleoside analogues treatment in the past half year.\n\nExclusion Criteria:\n\n1. Other active liver diseases;\n2. Hepatocellular carcinoma or other malignancy;\n3. Pregnancy or lactation;\n4. Human immunodeficiency virus infection or congenital immune deficiency diseases;\n5. Severe diabetes, autoimmune diseases;\n6. Other important organ dysfunctions;\n7. Using glucocorticoid;\n8. Patients can not follow-up;\n9. Investigator considering inappropriate.","12 Years",{"count":425,"type":20},[23],"This study is to investigate the clinical efficacy of three types of nucleotide\u002Fnucleoside analogues in treatment of HBV-related acute-on-chronic liver failure.",[506,26],[484,409,528,529],"nucleotide","nucleoside",{"date":489,"type":36},{"date":532,"type":36},"2019-02-21",{"date":493,"type":20},{"name":99,"class":43},{"id":536,"slug":537,"hasResults":12,"nctId":538,"briefTitle":539,"officialTitle":540,"acronym":4,"eligibilityCriteria":541,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":151,"enrollmentInfo":542,"targetDuration":4,"studyType":21,"phases":544,"briefSummary":545,"conditions":546,"keywords":4,"overallStatus":113,"whyStopped":4,"lastUpdateSubmitDate":547,"lastUpdatePostDateStruct":548,"startDateStruct":550,"completionDateStruct":552,"leadSponsor":554,"locationsCount":44},"100558849","safety-and-efficacy-of-continuous-infusion-of-terlipressin-with-norepinephrine-versus-norepinephrine-alone-in-improving-outcomes-of-acute-kidney-injury-in-acute-on-chronic-liver-failure-with-septic-shock-100558849","NCT06556472","Safety and Efficacy of Continuous Infusion of Terlipressin With Norepinephrine Versus Norepinephrine Alone in Improving Outcomes of Acute Kidney Injury in Acute on Chronic Liver Failure With Septic Shock","Safety and Efficacy of Continuous Infusion of Terlipressin With Norepinephrine Versus Norepinephrine Alone in Improving Outcomes of Acute Kidney Injury in Acute on Chronic Liver Failure With Septic Shock - A Randomised Controlled Trial","Inclusion Criteria:\n\n1. Age\\>18 years and \\\u003C60 yrs\n2. ACLF as per APASL\n3. AKI according to KDIGO Criteria\n4. septic shock requiring norepinephrine (\\\u003C0.05mcg\u002Fkg\u002Fmin).\n\nExclusion Criteria:\n\n1. Septic shock requiring 2 vasopressors (Norephinephrine reuirement \\> 0.05mcg\u002Fkg\u002Fmin)\n2. Symptomatic cardiopulmonary disease\n3. Chronic kidney disease\n4. Peripheral vascular disease\n5. Hepatocellular carcinoma outside Milan criteria\n6. Prior use of terlipressin in last 48 hours\n7. Patients with hypovolemic or hemorrhagic shock\n8. Patients already meeting criteria for dialysis or with history of dialysis in last 7 days\n9. Intrinsic kidney disease, Acute tubular necrosis with urinary output \\\u003C 400 ml \u002Fday or obstructive uropathy\n10. History of immunosuppressive drugs\n11. Pregnancy\n12. Human immunodeficiency virus 1 and 2\n13. Portal vein thrombus",{"count":543,"type":20},126,[23],"ACLF is defined differently in APASL,EASL and AASLD.APASL talks of reversibility in ACLF as per its definition and constitution of Homogenous population with ACLF.The definition of ACLF as per APASL is an acute hepatic insult manifesting as jaundice (serum bilirubin ≥ 5 mg\u002FdL (85 micromol\u002FL) and coagulopathy (INR ≥ 1.5 or prothrombin activity \\\u003C 40%) complicated within 4 weeks by clinical ascites and\u002For encephalopathy in a patient with previously diagnosed or undiagnosed chronic liver disease\u002Fcirrhosis, and is associated with a high 28-day mortality.\n\nAt the onset of septic shock there is initially an increased secretion of Arginine vasopressin. However, this initial rise is short lasting, and the vasopressin levels come back to normal or low serum levels with continued hypotension. However, even normal levels are too low for the degree of hypotension in septic shock. This causes a relative deficiency of vasopressin in septic shock. The exact time when this fall happens is not known and it is likely to be variable. Vasopressin was therefore tried as an agent in septic shock. Terlipressin is a synthetic analogue of vasopressin. It has a greater selectivity for the V1 receptor.\n\nCurrently, Norepinephrine is recommended as the first vasopressor to be started in general in septic shock population.(3) Catecholamines are the clinically used vasopressor agents of choice for supporting arterial blood pressure and ensuring adequate organ perfusion.\n\nDevelopment of adrenergic hyposensitivity with loss of catecholamine presser effects is seen in advanced stages of Vasodilatory Shock. Progressively increasing catecholamine therapy frequently enters into a vicious cycle of major adverse side effects resulting in continuous clinical deterioration necessitating further catecholamine excess.",[112],"2024-08-13",{"date":549,"type":36},"2024-08-16",{"date":551,"type":20},"2024-08-15",{"date":553,"type":20},"2025-08-31",{"name":122,"class":43},{"id":556,"slug":557,"hasResults":12,"nctId":558,"briefTitle":559,"officialTitle":560,"acronym":4,"eligibilityCriteria":561,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":85,"enrollmentInfo":562,"targetDuration":4,"studyType":21,"phases":563,"briefSummary":564,"conditions":565,"keywords":566,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":568,"lastUpdatePostDateStruct":569,"startDateStruct":571,"completionDateStruct":573,"leadSponsor":575,"locationsCount":44},"100515004","phase-1-human-umbilical-cord-mesenchymal-stem-cell-transplantation-for-the-treatment-of-acute-on-chronic-liver-failure-100515004","NCT05985863","Human Umbilical Cord Mesenchymal Stem Cell Transplantation for The Treatment of Acute-on-Chronic Liver Failure","Clinical Research of Human Umbilical Cord Mesenchymal Stem Cell Transplantation for The Treatment of Acute-on-Chronic Liver Failure","Inclusion Criteria:\n\n1. 18 years old ≤ age ≤ 70 years old, gender is not limited.\n2. Meet the APASL definition of ACLF: acute liver injury in patients with previously diagnosed or undiagnosed chronic liver disease or cirrhosis, manifested as jaundice (total bilirubin levels of 5 mg\u002Fdl or more) and coagulopathy (INR of 1.5 or more, or prothrombin activity of less than 40%） complicated within 4 weeks by clinical ascites, encephalopathy, or both.\n3. Willing to sign the informed consent form.\n\nExclusion Criteria:\n\n1. Patients with acute kidney injury, upper gastrointestinal hemorrhage, hepatic encephalopathy above grade II (inclusive) or uncontrolled infection at baseline;\n2. Before the onset of liver failure, the previous indicators of the patient included PLT\\\u003C50×10\\^9\u002FL or Child-Pugh score\\>9;\n3. Combined with liver cancer or other malignant tumors;\n4. Patients with previous liver transplantation or planned liver transplantation within 3 months;\n5. Severe organic disease of primary extrahepatic organs;\n6. Those who have a history of venous thrombosis or pulmonary embolism are judged by the investigator to be ineligible to participate in this trial;\n7. Pregnant, breastfeeding women or those who plan to have a baby in the near future;\n8. Those who are highly allergic or have a history of severe allergies;\n9. Those who have received immunosuppressant and immune enhancer treatment within 1 month;\n10. Drug abuse in the past 5 years;\n11. Alcohol withdrawal symptoms;\n12. A history of severe mental disorders within 24 months before screening, including uncontrolled major depression or controlled or uncontrolled psychosis;\n13. Those who have participated or are participating in other clinical trials within three months before screening, or have previously received stem cell therapy;\n14. Other conditions that the investigator thinks that the patient is not suitable to participate in this study.",{"count":425,"type":20},[244,155],"This study is a randomized double-blind placebo-controlled multicenter clinical trial to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell (UC-MSC) transplantation for the treatment of acute-on-chronic liver failure (ACLF). UC-MSC therapy may improve the clinical outcomes of patients with ACLF. The trial would provide scientific evidence for UC-MSC transplantation as a potential treatment for ACLF.",[26],[272,26,567],"Therapeutics","2024-05-06",{"date":570,"type":36},"2024-05-07",{"date":572,"type":36},"2023-09-30",{"date":574,"type":20},"2028-12-30",{"name":576,"class":43},"Beijing 302 Hospital",{"id":578,"slug":579,"hasResults":12,"nctId":580,"briefTitle":581,"officialTitle":581,"acronym":4,"eligibilityCriteria":582,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":241,"enrollmentInfo":583,"targetDuration":4,"studyType":21,"phases":585,"briefSummary":586,"conditions":587,"keywords":4,"overallStatus":113,"whyStopped":4,"lastUpdateSubmitDate":588,"lastUpdatePostDateStruct":589,"startDateStruct":591,"completionDateStruct":592,"leadSponsor":593,"locationsCount":44},"100537367","an-open-label-randomized-controlled-trial-comparing-the-role-of-therapeutic-plasma-exchange-in-ameliorating-secondary-organ-dysfunctions-in-patients-with-aclf-and-develop-biomarkers-of-treatment-response-100537367","NCT06276907","An Open-label Randomized Controlled Trial Comparing the Role of Therapeutic Plasma-exchange in Ameliorating Secondary Organ Dysfunctions in Patients With ACLF and Develop Biomarkers of Treatment Response","Inclusion Criteria:\n\n1. Patients with ACLF with AARC grade 2 or more with or without single secondary organ failure.\n\nExclusion Criteria:\n\n1. 1\\. Patients with age less than 18 years or more than 65 years\n2. Patients with HVOTO or EHPVO\n3. Hepatocellular carcinoma (beyond Milan) or any extrahepatic malignancy\n4. Active bleed (mucosal or variceal) or severe coagulopathy (platelets \\\u003C20,000 or INR\\>4)\n5. Patients with refractory shock requiring norepinephrine \\>0.5ug\u002Fkg\u002Fmin\n6. Patients with retroviral infections\n7. Pregnancy or active breastfeeding\n8. Known severe cardiopulmonary diseases (structural or valvular heart disease, coronary artery disease, coronary pulmonary disease, chronic kidney disease)\n9. Lack of informed consent",{"count":584,"type":20},190,[23],"Rationale: Current understanding of the pathophysiology of ACLF suggests that unresolved injury, poor infection control, and liver regeneration result in persistent systemic inflammation and cytokine storm, which subsequently lead to systemic inflammatory response syndrome (SIRS) resulting in multiple organ failures, septic shock and deaths in ACLF. Nearly 74% of ACLF patients initially diagnosed without SIRS, sepsis, or organ failure developed SIRS by day 7 which increases the onset of secondary organ failure and sepsis with high short-term mortality. The emerging use of plasma exchange has shown some potential benefits in terms of dampening systemic inflammation and improvement of outcomes in some ACLF patients. However, there is currently no randomized controlled trial exploring the potential role in ameliorating secondary organ dysfunctions in patients with ACLF is not known. Hence in the current objective, we want to study the role of plasma exchange in the management of sec. organ failure in ACLF patients in a randomized controlled trial and identify the biomarker to access the treatment response to therapy.",[112],"2024-02-23",{"date":590,"type":36},"2024-02-26",{"date":372,"type":20},{"date":75,"type":20},{"name":122,"class":43}]