[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"decompensated-cirrhosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:decompensated-cirrhosis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,41,92,117,145,165,195,224,248,270,293,317],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100533290","cirrhocare--using-smart-phone-technology-to-enhance-care-and-access-to-treatment-for-cirrhosis-100533290",false,"NCT06223893","CirrhoCare- Using Smart-phone Technology to Enhance Care and Access to Treatment for Cirrhosis","CirrhoCare, A Real-world, Randomised Controlled Study, to Determine the Clinical and Cost-effectiveness of CirrhoCare Digital Home Monitoring and Management in Patients With Decompensated Cirrhosis","CirrhoCare","Inclusion criteria:\n\n1. Adults ≥ 18 years and diagnosed with cirrhosis of any aetiology.\n2. Cirrhosis defined by standard clinical criteria, ultrasonographic findings and\u002For histology. Cirrhosis of any aetiology may be included. However, participants with cirrhosis due to autoimmune hepatitis must be on a stable corticosteroid dose for ≥3-month period before study inclusion (to be recorded on concomitant log).\n3. Cirrhosis severity-risk defined by European-Foundation Consortium Liver Failure - Acute Decompensation score (CLIF-C AD score) ≥42 points but ≤65 points at the time of screening.\n4. Hospitalisation for acute decompensation \\[determined as one or more of the following: increasing ascites, variceal haemorrhage, overt hepatic encephalopathy, spontaneous bacterial peritonitis (SBP) or hepatorenal syndrome - acute kidney injury (HRS-AKI)\\].\n5. Participants able to give informed consent.\n\nExclusion criteria:\n\n1. Participants with ACLF grade 2 and above according to the criteria published by Moreau\n2. Participants with CLIF-C AD score ≥ 66, who have a high mortality similar to ACLF ≥2 participants.\n3. Current overt hepatic encephalopathy, defined as grade II-IV hepatic encephalopathy according to the West-Haven classification, unable to give consent.\n4. Participants with active hepatocellular carcinoma (HCC) or history of HCC that is in remission for less than six months for uninodular HCC or for less than 12 months for multinodular HCC within Milan criteria.\n5. Participants with a history of significant extra hepatic disease with impaired short-term prognosis, including congestive heart failure New York Heart Association Grade III\u002FIV, COPD GOLD \\>2, chronic kidney disease with serum creatinine \\>2mg\u002FdL or under renal replacement therapy.\n6. Participants with documented refractory ascites on a palliative pathway.\n7. Participants who are active on the transplant waiting list.\n8. Participants with current extra hepatic malignancies including solid tumours and hematologic disorders.\n9. Participants with mental incapacity, significant language barriers, or any other reason considered by the investigator precluding adequate understanding, cooperation or compliance in the study.\n10. Participants with active viral infections, or yet to achieve clear response to anti-viral therapy.\n11. Any disorders likely to impact on study engagement, including severe frailty, severe addiction history (including opioids) with evidence of multiple recent relapses.\n12. Any other reason that the PI considers would make the participant unsuitable to enter CirrhoCare (e.g., participants on an end-of-life palliative care pathway).\n13. Participants enrolled in other interventional trials.","ALL","18 Years",{"count":20,"type":21},214,"ESTIMATED","INTERVENTIONAL",[24],"NA","The CirrhoCare trial is a multi-centre, open label randomised controlled trial in patients with decompensated cirrhosis. The trial aims to investigate the clinical and cost-effectiveness of CirrhoCare digital home monitoring and management with current standard of care in these patients.",[27],"Decompensated Cirrhosis","RECRUITING","2026-04-30",{"date":31,"type":32},"2026-05-07","ACTUAL",{"date":34,"type":32},"2023-11-24",{"date":36,"type":21},"2027-01-31",{"name":38,"class":39},"University College, London","OTHER",15,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":55,"conditions":56,"keywords":64,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":91},"100579393","phase-1-rtx001-autologous-engineered-macrophages-for-liver-cirrhosis-100579393","NCT06823713","RTX001 Autologous Engineered Macrophages for Liver Cirrhosis","An Open-label Phase 1\u002F2 Multicentre Study to Evaluate the Safety, Tolerability and Efficacy of RTX001 Autologous Macrophages in Participants With Liver Cirrhosis Who Have Hepatic Decompensation (EMERALD)","EMERALD","Individuals eligible to participate in this study must meet the following criteria:\n\nInclusion Criteria:\n\n1. Male or female age ≥18-75 years.\n2. Patient confirms willingness\u002Fability to comply with all study procedures.\n3. Diagnosis of liver cirrhosis based on at least one of:\n\n   1. Clinical and radiological features that correlate with a diagnosis of cirrhosis.\n   2. Transient elastography (Fibroscan) \\>15 kPa.\n   3. Previous liver biopsy confirming histological features of cirrhosis.\n4. Aetiology of liver disease of steatotic liver disease including MASLD or Met-ALD or ALD\n\n   a. Participants with alcohol-related liver disease (ALD or Met-ALD) only if they are confirmed to not be drinking alcohol above Met-ALD limits defined in this protocol. (N.B. No more than 34% of the total treated participants in this protocol will be ALD \\[excludes Met-ALD\\]).\n5. Hospitalised as an inpatient for a recent major hepatic decompensation event including ascites, hepatic encephalopathy, variceal bleed, HRS-AKI or SBP, this being the only hospitalisation for an hepatic decompensation event hospitalisation within the last 6 months, and where recent is defined as within 6 weeks of hospital discharge.\n6. Outpatient: Medically refractory ascites (ONLY), that recurs (i.e., second therapeutic LVP) within a 6-month period. Medically refractory ascites is defined by the repeated (≥2) need for LVP (i.e., therapeutic, not diagnostic) at least once per 8 weeks despite best medical attempts to control the ascites by sodium restriction and diuretic treatment, as confirmed by the Investigator. Onset is defined as the date of the second therapeutic LVP.\n7. Confirmatory PEth alcohol test \\\u003C200 ng\u002Fml\n8. MELD score of 12-20 taken within two weeks of 'qualifying' decompensation event.\n9. No known contradictions to filgrastim or leukapheresis procedure.\n10. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n11. Willing and able to give signed informed consent, and if applicable assent.\n\nParticipants are excluded from the study if any of the following criteria apply:\n\nExclusion Criteria:\n\n1. Liver cirrhosis due to:\n\n   1. any viral hepatitidies, or\n   2. autoimmune and cholestatic aetiologies including, but not limited to, primary biliary cholangitis and primary sclerosing cholangitis.\n2. Acute liver disease in the absence of underlying liver cirrhosis, including, but not limited to, drug induced liver injury.\n3. Any current organ failure requiring more than outpatient supportive care, and not associated with the participant's qualifying hepatic decompensation event.\n4. Known splenomegaly ≥16 cm.\n5. Thrombocytopenia \\\u003C50×109\u002FL.\n6. Presence or suspicion of any of the following co-morbidities:\n\n   1. History of liver transplantation or other organ transplant.\n   2. ACLF.\n   3. Sepsis (with positive microbial cultures) or as defined by the Principal Investigator, unless stable and is at least 4 weeks after having completed a full course of IV antibiotics.\n   4. Known human immunodeficiency virus.\n   5. Known syphilis.\n   6. Known human T-lymphotropic virus 1.\n   7. Pulmonary embolism.\n   8. Hepatocellular carcinoma, or any active malignant disease within the last five years, (excluding non-melanoma skin cancer, cervical carcinoma in situ, superficial bladder cancer, benign polyps etc.).\n   9. Co-hepatic morbidities e.g., portal vein thrombosis.\n   10. Participants with hepatic hydrothorax are excluded unless it is a small hydrothorax, not clinically apparent, that is detected incidentally by radiologic evaluation that does not require clinical intervention.\n   11. Chronic renal impairment (on dialysis) or unresolved AKI.\n   12. Acute or chronic heart failure (New York Heart Association Grade III\u002FIV).\n   13. Porto-pulmonary hypertension.\n   14. Severe chronic lung disease e.g., chronic obstructive pulmonary disease or interstitial lung disease where the forced expiratory volume in the first second (FEV1) is less than 50% and\u002For FEV1\u002Fforced vital capacity is less than 60%.\n   15. Hepatopulmonary syndrome.\n   16. Previous or current treatment with multiple infusions of albumin for therapeutic intent. \\[Use of albumin infusion at the time of large volume paracentesis for circulatory support is allowed.\\]\n   17. Significant untreated\u002Funstable psychiatric disease.\n   18. Transjugular intrahepatic portosystemic shunt (TIPSS).\n7. As judged by the Investigator, any evidence of intercurrent illness that is either life threatening or of clinical significance such that it might limit compliance with study procedures.\n8. Current or planned use of immunomodulators or immunosuppressive medication; note: low doses of corticosteroids up to 10 mg\u002Fkg\u002Fday prednisone or equivalent are permitted, or inhaled steroids to manage asthma.\n9. Received a gene or cell therapy at any time.\n10. Current or planned use of a live attenuated vaccines four weeks or fewer prior to enrolment (and for 3 months after the last administered dose of RTX001).\n11. Received any investigational product within the past 6 months, or five half-lives (whichever is longer) or participated in another investigational interventional study within 30 days prior to the screening visit.\n12. Participants with a known hypersensitivity to dimethyl sulfoxide (DMSO).\n13. Judgment by the Investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions and requirements.\n14. For female participants only - pregnant or breast-feeding or plans to become pregnant over the next year, or of childbearing potential and unwilling to comply with contraceptive requirements.\n15. Alcohol misuse in the period between identification of the participant as potentially suitable for this study to Screening (Visit 1), defined as alcohol intake greater than three units\u002Fday for females and four units\u002Fday for males, or binge drinking (\\>14 units\u002Fday) as determined by the Investigator. N.B. One unit is equivalent to 14 g of alcohol: a half-pint (\\~240 mL) of beer, one glass (125 mL) of wine or one (25 mL) measure of spirits.\n16. Intake of non-medically supervised drugs of abuse that are judged (by the Investigator) to be a high risk to the participants acute health or which makes the participant likely to be non-compliant with follow-up.","75 Years",{"count":51,"type":21},30,[53,54],"PHASE1","PHASE2","The purpose of this study is to assess the safety and efficacy of RTX001 in patients with end-stage liver disease. This study is the first time RTX001, a macrophage cell therapy engineered to have an anti-inflammatory and anti-fibrotic effect, will be given to humans.",[57,58,59,60,61,62,27,63],"End-stage Liver Disease (ESLD)","Cirrhosis, Liver","Cirrhosis, Decompensated","Liver Diseases","Fibrosis and Cirrhosis of Liver","Decompensated Liver Cirrhosis","Steatotic Liver Disease",[65,66,67,68,69,62,70,71,72,73,74,75,76,77,78,79,80,63],"Liver cirrhosis","Cirrhotic","Hepatic Cirrhosis","Chronic Liver Disease","Liver Fibrosis","Child-Pugh Score","MELD Score","Liver Function Tests","Hepatic Encephalopathy","End Stage Liver Disease (ESLD)","Variceal Bleeding","Jaundice","Retractable Ascites","Autologous","Cell Therapy","Macrophage","2026-01-27",{"date":83,"type":32},"2026-01-28",{"date":85,"type":32},"2024-10-15",{"date":87,"type":21},"2028-11-29",{"name":89,"class":90},"Resolution Therapeutics Limited","NETWORK",14,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":22,"phases":102,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":4},"100613767","phase-4-study-to-evaluate-the-efficacy-of-intravenous-administration-of-human-albumin-versus-saline-solution-in-patients-with-descompnsate-cirrhosis-grade-1b-or-higher-renal-failure-100613767","NCT07270874","Study to Evaluate the Efficacy of Intravenous Administration of Human Albumin Versus Saline Solution in Patients With descompénsate Cirrhosis Grade 1B or Higher Renal Failure","LIVER AKI: A Randomized, Open-label Trial to Evaluate the Efficacy of Intravenous Human Albumin Administration Versus Saline Solution (NaCl 0.9%) in Patients With descompénsate Cirrhosis and AKI 1B or Grater","LIVER-AKI","Inclusion Criteria:\n\n1. Age ≥ 18 years old.\n2. Cirrhosis defined by standard clinical criteria, ultrasonographic findings and\u002For histology. (Cirrhosis of any etiology may be included).\n3. Patients with AKI 1B or greater, defined according to EASL guidelines (EASL. J Hepatol 2018).\n4. Women of child-bearing potential\\* must have a negative pregnancy test in serum before the inclusion in the study and agree to use highly effective contraceptive methods during the study. Highly effective contraceptive methods will include: intrauterine device, bilateral tubal occlusion, vasectomized partner and sexual abstinence\\*\\* (only if refraining from heterosexual intercourse during the period of twelve months). Hormonal contraceptive methods will be avoided due to the risk of adverse events and impairment of liver function\n\nExclusion Criteria:\n\n1. Time since AKI diagnosis \\> 24 hours.\n2. Patients with AKI due to pure hypovolemia. According to guidelines, these patients should receive crystalloid solutions (i.e. NaCl 0.9%) and will be excluded from the study. Fluid losses will be specifically assessed by an accurate anamnesis and physical examination. If patient's diuretic treatment has been increased recently (within prior 2 weeks), or the patient had diarrhea before admission, patient will be considered that the AKI phenotype is pre-renal and will be excluded from the analysis. Patients will be excluded when clear evidence of hypovolemia is present, based on clinical history (e.g, recent fluid losses, diuretic escalation, diarrhea) and corroborating physical findings (e.g, dry mucous membranes, reduced skin turgor, sunken eyes, or low jugular venous pressure)\n3. Patients with AKI due to gastrointestinal bleeding with AKI 1B or greater, and hemoglobin \\\u003C 7.0 g\u002FdL. These patients can be included after 48 hours without rebleeding and Hb ≥ 8.0 g\u002FdL, and still present AKI 1B or greater.\n4. Patients who had already received albumin at the time of inclusion\u002Fexclusion criteria assessment.\n5. Patients with Chronic kidney disease grade 3a or higher, defined as glomerular filtration rate \\\u003C60ml\u002Fmin for three months and markers of kidney damage (one or more): Albuminuria (Albumin excretion rate \\> 30 mg\u002F24h; Albumin-to-creatinine ratio \\> 30 mg\u002Fg), Urine sediment abnormalities, Electrolyte and other abnormalities due to tubular disorders, Abnormalities detected by histology or Structural abnormalities detected by imaging.\n6. Patients under renal replacement therapy, or with urgent criteria of RRT.\n7. Patients with hepatocellular carcinoma beyond Milan criteria.\n8. Patients with severe extrahepatic comorbidities, including congestive heart failure New York Heart Association Grade III\u002FIV, chronic obstructive pulmonary disease Global Initiative for Chronic Obstructive Lung Disease group 2 or higher.\n9. Previous liver and\u002For kidney transplantation.\n10. Patients with current extra hepatic malignancies including solid tumors and hematologic disorders.\n11. Patients included in other clinical trials in the month before inclusion.\n12. Patients with mental incapacity, language barrier, bad social support or any other reason considered by the investigator precluding adequate understanding, cooperation or compliance in the study.\n13. Refusal to give informed consent.",{"count":101,"type":21},114,[103],"PHASE4","This is a phase IV, unicentric, open-label. Patients eligible for this study will be patients with AKI 1B or greater and decompensated cirrhosis from the hospital participating in the study",[27,106],"AKI - Acute Kidney Injury","NOT_YET_RECRUITING","2025-12-16",{"date":110,"type":32},"2025-12-18",{"date":112,"type":21},"2026-01",{"date":114,"type":21},"2028-02",{"name":116,"class":39},"Fundacion Clinic per a la Recerca Biomédica",{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":125,"enrollmentInfo":126,"targetDuration":4,"studyType":22,"phases":128,"briefSummary":129,"conditions":130,"keywords":131,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":144},"100603035","national-collaborative-centre-for-hepatic-regenerative-medicine-nc-chrm-single-vs-repeated-cycle-of-granulocyte-colony-stimulating-factor-gcsf--darbepoetin-in-early-decompensated-cirrhosis-100603035","NCT07131280","National Collaborative Centre for Hepatic Regenerative Medicine (NC-CHRM): Single vs Repeated Cycle of Granulocyte Colony-Stimulating Factor (GCSF) & Darbepoetin in Early Decompensated Cirrhosis","National Collaborative Centre for Hepatic Regenerative Medicine(NC-CHRM): To Study the Efficacy of Single vs Repeated Cycle of GCSF+ Darbepoetin in Long Term Transplant Free Management of Patient With Early Decompensated Cirrhosis","NC-CHRM","Inclusion Criteria:\n\n* Early decompensated cirrhosis patients with MELD \\\u003C16\n\nExclusion Criteria:\n\n* Patients with age less than 18 years or more than 65 years\n* Patients with Grade III ascites\n* CHILD C cirrhosis\n* Patients with a known focus of sepsis; spontaneous Bacterial Peritonitis (SBP)\n* variceal bleeding in past 3months\n* Hepatocellular Carcinoma (HCC) or other malignancy\n* Acute Kidney Injury (AKI) with serum Creatinine \\>1.5 mg\u002F dl, multi-organ failure, grade 3 or 4 Hepatic Encephalopathy (HE),\n* HIV seropositivity\n* Medically uncontrolled essential hypertension\n* Pregnancy\n* Viral etiology of liver disease\n* Co-existent Hepatitis B, Hepatitis C, HIV\n* Chronic kidney disease\n* Lack of informed consent","65 Years",{"count":127,"type":21},110,[24],"Chronic liver disease is a growing health concern, with limited access to liver transplants. This study addresses the urgent need for alternatives by exploring regenerative therapies, like G-CSF, to boost the liver's natural repair. The goal is to develop safe, effective, and accessible treatments for patients who cannot undergo transplant.",[27],[132,133,134],"GCSF","Decompensated cirrhosis","Darbepoetin","2025-08-19",{"date":137,"type":32},"2025-08-20",{"date":139,"type":21},"2025-09",{"date":141,"type":21},"2031-12",{"name":143,"class":39},"Institute of Liver and Biliary Sciences, India",1,{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":151,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":22,"phases":154,"briefSummary":155,"conditions":156,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":144},"100546588","hospital--home-model-of-care-for-cirrhosis-100546588","NCT06396897","Hospital @ Home Model of Care for Cirrhosis","The Hospital @ Home Model of Care: A Novel Healthcare Solution for the Management of Decompensated Cirrhosis","H@H","Inclusion Criteria:\n\n* Enrolled into IUH's H@H program\n* At least 18 years of age\n* Chronic liver disease\u002Fcirrhosis based on characteristic clinical, laboratory, and imaging findings\n* English speaking\n* Able to provide consent\n* Caregiver able to be present during the acute phase of care (first 48 hours post-hospital discharge)\n* Able to perform activities of daily living independently\n* Lives within IU Health Home service area\n\nExclusion Criteria:\n\n* Unable to complete study questionnaires due to neurocognitive disease, legal blindness or hearing loss\n* Transplant of organ other than liver\n* Pregnant\n* Incarcerated\n* New hemodialysis\n* Blood pressure \\\u003C 90\u002F60, Pulse \\> 120, O2 \\> 6L or \\>2L above baseline\n* HIV+\u002FCD4 count \\\u003C 200\n* Receiving hospice services\n* Concurrent enrollment in a related research study",{"count":51,"type":21},[24],"The purpose of this study is to work with patients diagnosed with end-stage liver disease to understand their perspectives on the Health at Home (H@H) Program, including desired outcomes and expectations, perceived barriers, and drivers. H@H is an emerging model of home-based care, designed to extend traditional, inpatient hospital care which may address these needs. Through H@H, acute medical care services as well as ancillary care such as rehabilitation therapy can be delivered in the home. The study is divided into three phases: Phase 1 occurs while the participant is an inpatient. Phase 2 is when the actual H@H program takes place as part of the participant's clinical care. The study team will not be involved in the Phase 2 - H@H program as it will be conducted by the clinical staff. Phase 3, at which point the participant enters a rehabilitation phase to transition the patient to self-management, involves a research jam session with the participant and caregiver to assess the value of the program.",[27],"2025-08-14",{"date":135,"type":32},{"date":160,"type":32},"2024-05-10",{"date":162,"type":21},"2027-12-31",{"name":164,"class":39},"Indiana University",{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":171,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":173,"targetDuration":4,"studyType":175,"phases":4,"briefSummary":176,"conditions":177,"keywords":183,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":194},"100599634","a-study-to-predict-recompensation-in-patients-with-decompensated-cirrhosis-using-spleen-stiffness-and-simple-blood-tests-100599634","NCT07087041","A Study to Predict Recompensation in Patients With Decompensated Cirrhosis Using Spleen Stiffness and Simple Blood Tests","Prediction of Recompensation and Stable Recompensation in Patients With Decompensated Cirrhosis Using Spleen Stiffness Combined With Non-Invasive Markers: A Prospective, Observational, Multicenter Study","LEAD-2","Inclusion Criteria:\n\n* Male or female, aged 18 to 75 years (inclusive)\n* Clinically diagnosed decompensated cirrhosis\n* First decompensated event occurred within 12 months of screening, or no decompensated events in the past 12 months despite a history of decompensation\n* Received effective etiological treatment per guidelines:\n\n  * For HBV: Sustained antiviral suppression\n  * For alcohol-related liver disease: Sustained abstinence for ≥2 months\n  * For MAFLD-related cirrhosis: Improved liver function after lifestyle\u002F metabolic intervention\n\nExclusion Criteria:\n\n* Missing data on first decompensated event\n* Prior orthotopic liver transplantation or TIPS\n* Prior splenectomy, splenic embolization, or other shunt surgery\n* History or current diagnosis of hepatocellular carcinoma\n* Acute variceal bleeding within the last 4 weeks or unstable condition\n* Uncontrolled moderate-to-severe ascites\n* Cholestatic cirrhosis; untreated chronic liver diseases; non-cirrhotic portal hypertension; vascular liver diseases (e.g., Budd-Chiari syndrome)\n* Acute or chronic portal vein thrombosis\n* Severe comorbidities of heart, lung, kidney, brain, hematologic, or psychiatric systems\n* Other systemic malignancies (except cured cases)\n* Pregnant or breastfeeding women",{"count":174,"type":21},735,"OBSERVATIONAL","The goal of this observational study is to learn if spleen stiffness and other non-invasive markers can help predict recompensation in people with decompensated cirrhosis who are receiving effective treatment for the cause of their liver disease. The main questions it aims to answer are:\n\n* Can spleen stiffness and blood test results predict who will get better and stay better after cirrhosis becomes worse?\n* What are the features of people who recover after decompensation?\n\nParticipants will:\n\n* Be people with decompensated cirrhosis who are already getting effective treatment (such as antiviral therapy or alcohol abstinence)\n* Be followed over time to check if they remain stable or have more liver problems\n* Have non-invasive tests done, including spleen stiffness measurement and blood tests\n\nResearchers will track how many participants recover and stay recovered over time, and use that information to build a tool to help predict outcomes in others with cirrhosis.",[27,178,179,180,181,182],"Hepatitis B Virus (HBV) Infection","Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)","Alcohol-Related Liver Disease","Portal Hypertension","Recompensation",[182,27,184],"Spleen Stiffness","2025-07-23",{"date":187,"type":32},"2025-07-25",{"date":189,"type":21},"2025-07-15",{"date":191,"type":21},"2028-12-30",{"name":193,"class":39},"Beijing Friendship Hospital",28,{"id":196,"slug":197,"hasResults":11,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":201,"eligibilityCriteria":202,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":125,"enrollmentInfo":203,"targetDuration":4,"studyType":22,"phases":205,"briefSummary":206,"conditions":207,"keywords":209,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":144},"100557435","phase-4-bcaa-vs-rifaximin-in-patients-with-cirrhosis-for-secondary-prophylaxis-of-he-100557435","NCT06538077","BCAA vs. Rifaximin in Patients With Cirrhosis for Secondary Prophylaxis of HE","Branch Chain Amino Acids vs. Rifaximin in Patients With Cirrhosis for Secondary Prophylaxis of Hepatic Encephalopathy: Double-blind Placebo-controlled Multicentric Randomized Controlled Trial","HERB","Inclusion Criteria:\n\n1. Cirrhosis defined by standard clinical, ultrasonographic findings and\u002For histological criteria. Cirrhosis of any etiology may be included. However, patients with cirrhosis due to autoimmune hepatitis must be on stable corticosteroid doses for ≥3-month period before study inclusion; those with viral hepatitis, must similarly be on anti-viral therapy with controlled viremia or with SVR.\n2. Any gender\n3. Discharged from the hospital following an episode of overt hepatic encephalopathy.\n4. Participants able to give informed consent\n\nExclusion Criteria:\n\n1. Subjects with active bacterial or fungal infection\n2. Subjects with active or very recent gastrointestinal bleeding in the last 2 weeks.\n3. Current overt hepatic encephalopathy, defined as grade II-IV hepatic encephalopathy according to the West-Haven classification.\n4. Conditions that can impact interpretation of cognitive function:\n\n   i) Untreated viremic hepatitis C virus infection ii) Established neurological\u002Fdegenerative disorders iii) Patient undergoing active alcohol withdrawal treatment Iv) Patient is intoxicated or under the influence of illicit drugs as per clinician assessment V) Treatment with antipsychotics or other psychotropic drugs with sedative effects\n5. Patients with active hepatocellular carcinoma or history of hepatocellular carcinoma that is in remission for less than six months.\n6. Patients with a history of significant extrahepatic disease with impaired short-term prognosis, including: i) Congestive heart failure New York Heart Association Grade III\u002FIV or ejection fraction\\\u003C30% ii) COPD: GOLD \\>2, ii) Chronic kidney disease with serum creatinine \\>2mg\u002FdL or under renal replacement therapy.\n7. Patients with current extra hepatic malignancies, including solid tumours and hematologic disorders.\n8. Patients with MELD\\>20\n9. Patients with mental incapacity, or those unlikely to survive 12 weeks or any other reason considered by the investigator precluding adequate understanding, cooperation, or compliance in the study activities.\n10. Patients with TIPS shunt in situ\n11. Pregnancy (urine pregnancy test at inclusion)\n12. Refusal or inability to give informed consent",{"count":204,"type":21},336,[103],"Rationale\n\n* Patients who recover from an episode of overt HE(OHE) are at risk of recurrent episodes of HE and persistent minimal hepatic encephalopathy, impacting their daily functioning and mental health.\n* A multicentric pan-India team will evaluate the role of oral branched-chain amino acids (BCAA) vs Rifaximin as secondary prophylaxis following overt HE as compared with improvement in cognitive function.\n\nNovelty:\n\n* This study is intended to investigate the role of BCAA vs rifaximin as the ideal second-line therapy for HE management, recurrence, and overall health, including cognitive function, depression and anxiety.\n* The head-to-head comparison of BCAA+lactulose+ pill-placebo vs rifaximin+ lactulose+ powder-placebo ensures minimization of bias and has adequate power to determine rates of recurrence,\n\nObjectives:\n\n* To assess the 1st breakthrough episode of HE during 6months in BCAA vs rifaximin groups as ideal secondary prophylaxis in HE. Methodology\n* Double-blind placebo-controlled double-dummy randomized trial of BCAA supplementation vs rifaximin as the ideal second-line therapy in patients with cirrhosis who have recovered from an episode of OHE. Expected Outcome\n* Ideal second line agent HE prophylaxis (rifaximin or BCAA) following 1st line lactulose is unclear in an Indian context where dysbiosis and sarcopenia are prevalent, and cost of therapy needs to be optimized.\n* Optimal HE management prevents recurrence episodes of HE, and improves prognosis, neurocognitive function, and overall health-related quality of life(HRQOL).\n* Creation of a management algorithm based deductive models incorporating etiology and severity of liver disease, cognitive performance, sarcopenia, and ammonia, and neuropsychiatric impact of using BCAA vs Rifaximin will be created.",[73,27,208],"Minimal Hepatic Encephalopathy",[210,211,212,213,214],"Hepatic encephalopathy","Branched-chain amino acids","Computerized neurocognitive test battery","Double blind placebo controlled multicentric randomized controlled trial","rifaximin","2025-06-05",{"date":217,"type":32},"2025-06-10",{"date":219,"type":32},"2025-02-01",{"date":221,"type":21},"2027-08",{"name":223,"class":39},"Post Graduate Institute of Medical Education and Research, Chandigarh",{"id":225,"slug":226,"hasResults":11,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":230,"eligibilityCriteria":231,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":125,"enrollmentInfo":232,"targetDuration":4,"studyType":22,"phases":234,"briefSummary":235,"conditions":236,"keywords":240,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":243,"startDateStruct":245,"completionDateStruct":246,"leadSponsor":247,"locationsCount":144},"100549277","carvedilol--simvastatin-vs-carvedilol-alone-for-cirrhosis-and-cirrhotic-cardiomyopathy-and-impact-on-hepatic-decompensation-and-survival-100549277","NCT06431919","Carvedilol + Simvastatin vs. Carvedilol Alone for Cirrhosis and Cirrhotic Cardiomyopathy and Impact on Hepatic Decompensation and Survival","Carvedilol + Simvastatin vs. Carvedilol Alone for Chronic Liver Disease and Cirrhotic Cardiomyopathy and Its Impact on Hepatic Decompensation and Survival; a Double-blind Randomized Controlled Trial","CIRROSTAT","Inclusion Criteria:\n\n* Age range of 18-65 years\n* Compensated cirrhosis, as diagnosed by histology or clinical, laboratory and USG findings,\n* CCM (with EF\\>50%) on 2D echocardiography with TDI\n* Written informed consent.\n\nExclusion Criteria:\n\n* Age \\>65 years\n* Serum Creatinine\\>2 mg\u002Fdl\n* Patient previously treated with statin (one month before the study)\n* Contraindications to statins\n* Advanced Cirrhosis (CTP score\\>9)\n* Coronary artery disease\n* Sick sinus syndrome\u002F Pacemaker, valvular heart disease\n* Cardiac rhythm disorder, Peripartum cardiomyopathy\n* Portopulmonary hypertension\u002F hepatopulmonary syndrome\n* Transjugular intrahepatic portosystemic shunt (TIPS) insertion\n* Hepatocellular carcinoma\n* Pregnancy or lactation\n* Patients with HIV or retroviral therapy\n* Anemia Hb \\\u003C 8gm\u002Fdl in females, and \\\u003C 9 gm\u002Fdl in males\n* Acute variceal bleeding in last 6 months.\n* Need for medications, metabolized by CYP3A4(such as amlodipine, verapamil, fenofibrate azole antibiotics, protease inhibitors etc.)",{"count":233,"type":21},260,[24],"Cirrhosis and portal hypertension are associated with a hyperdynamic circulation and decompensation events, including development of ascites, variceal bleeding, acute kidney injury, and susceptibility to infections.\n\nRationale:\n\nCirrhosis and portal hypertension are associated with a hyperdynamic circulation and decompensation events, including ascites, variceal bleeding, acute kidney injury, and susceptibility to infections. CCM, present in 30-70% of patients, is characterized by structural and functional abnormalities in the heart, and is associated with progression of cirrhosis, impaired quality of life and poor survival. Statins play a crucial role in reducing proatherogenic LDL cholesterol levels, making them a cornerstone in managing diabetes and cardiovascular diseases (CVDs) with the aim of decreasing or reversing atherosclerosis. This trial aims to evaluate the impact and safety of simvastatin in cirrhotic cardiomyopathy.\n\nNovelty: Simvastatin might be of special value in diastolic dysfunction through its hemodynamic and functional effects on LV remodeling and improve portal hemodynamics through the pleotropic effects of lipophilic statins.\n\nObjectives:\n\nThe primary objective is to assess the combined effects of carvedilol and simvastatin in managing CCM vs carvedilol alone for a composite outcome to prevent decompensation and reduce all-cause mortality. We will comprehensively evaluate cardiac function, decompensation events and survival based on impact of simvastatin over the standard betablocker carvedilol.\n\nMethods:\n\nThis is a double-blinded randomized placebo-controlled trial involving patients diagnosed with CCM. Clinical data, including cardiac imaging, cardiac biomarkers, and survival outcomes, will be assessed for either group.\n\nExpected Outcome:\n\nThe investigators anticipate that the synergistic use of simvastatin and carvedilol will effectively reduce portal pressure, improve portal haemodynamic, and enhance cardiac remodelling. Successful reversal of LVDD can potentially prevent clinical events such as ascites, encephalopathy, and acute kidney injury (AKI).",[27,237,58,238,239],"Cirrhotic Cardiomyopathy","Left Ventricular Diastolic Dysfunction","Acute Kidney Injury",[27,237,241,242],"Left ventricular diastolic dysfunction","Acute kidney injury",{"date":244,"type":32},"2025-06-08",{"date":217,"type":21},{"date":114,"type":21},{"name":223,"class":39},{"id":249,"slug":250,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":4,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":255,"targetDuration":4,"studyType":22,"phases":257,"briefSummary":258,"conditions":259,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":269},"100456543","phase-2-human-umbilical-cord-derived-mesenchymal-stem-cells-for-decompensated-cirrhosis-msc-dlc-2-100456543","NCT05224960","Human Umbilical Cord-derived Mesenchymal Stem Cells for Decompensated Cirrhosis (MSC-DLC-2)","A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Human Umbilical Cord-derived Mesenchymal Stem Cells in the Treatment of Decompensated Cirrhosis Patients(MSC-DLC-2)","Inclusion Criteria:\n\n1. Willing to provide written informed consent;\n2. Aged 18 to 75 years (including 18 and 75 years), male or female;\n3. Patients diagnosed with decompensated liver cirrhosis based on clinical findings, laboratory tests, imaging findings and\u002For representative pathological findings (decompensated liver cirrhosis is defined as the occurrence of at least one serious complication, including esophageal and gastric varices bleeding, hepatic encephalopathy, ascites, spontaneous bacterial peritonitis and other serious complications);\n4. The Model for End-stage Liver Disease (MELD) score 15 to 30 points.\n\nExclusion Criteria:\n\n1. Appearance of active variceal bleeding, overt hepatic encephalopathy (HE), refractory ascites or hepatorenal syndrome within 1 month prior to screening visit.\n2. Uncontrolled severe infection within 2 weeks of screening.\n3. Patients with hepatitis B virus-related decompensated liver cirrhosis may discontinue antiviral therapy during the study, or those who with antiviral therapy for HBV for less than 12 months, or hepatitis B virus (HBV) DNA ≥ detection limit at the time of screening.\n4. Patients with hepatitis C virus-related decompensated liver cirrhosis may discontinue antiviral therapy during the study, or those who with antiviral therapy for HCV for less than 12 months, or hepatitis C virus (HCV) RNA ≥ detection limit at the time of screening (except HCV RNA\\\u003C detection limit without any antiviral treatment).\n5. Patients under treatment with corticosteroids for autoimmune hepatitis for less than 6 months.\n6. Trans-jugular intrahepatic portosystemic shunts (TIPS) insertion within 6 months prior to study inclusion.\n7. Active drinkers with alcohol-related decompensated cirrhosis are unwilling to stop alcohol abuse after inclusion.\n8. Significant renal insufficiency (serum creatinine ≥ 1.2 times upper normal limit); Severe electrolyte abnormality (serum sodium level \\\u003C 125 mmol\u002FL); Severe leukopenia (white blood cell count \\\u003C 1 × 10E9\u002FL).\n9. Patients with biliary obstruction, or portal vein spongiosis.\n10. Patients with surgical history such as splenic cut-off flow.\n11. Patients with malignant tumors within 5 years, except those with basal cell carcinoma, squamous cell carcinoma and\u002For carcinoma in situ who had received curative treatment and curative resection.\n12. Patients with a prior history of major organ transplantation or complicated with significant disease of heart, lung, kidney, blood, endocrine and other systems.\n13. Drug abuse, drug dependence and patients who receive methadone treatment or with psychosis.\n14. Against the human immunodeficiency virus antibody (Anti - HIV) or syphilis antibody test results were positive.\n15. Pregnancy, lactation or with recent fertility plan during the test and 6 months after the test.\n16. Highly allergic, or have a history of severe allergies, known severe allergies to the investigational drug or any of the excipients.\n17. History of pulmonary embolism.\n18. Patients who had previously received stem cell therapy or were intolerant to cell therapy.\n19. The proposed line of liver transplants within three months.\n20. Participants in other clinical trials within the last 3 months.\n21. Any other clinical condition which the investigator considers would make the patient unsuitable for the trial.",{"count":256,"type":21},140,[54],"Decompensated cirrhosis has a high overall mortality rate. There is a large unmet need for safe and alternative therapeutic potions. This clinical trial is to inspect the efficiency and safety of mesenchymal stem cells (MSCs) therapy for decompensated cirrhosis.",[27],"2024-10-17",{"date":262,"type":32},"2024-10-18",{"date":264,"type":32},"2024-06-27",{"date":266,"type":21},"2027-06-20",{"name":268,"class":39},"Beijing 302 Hospital",7,{"id":271,"slug":272,"hasResults":11,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":276,"eligibilityCriteria":277,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":278,"targetDuration":4,"studyType":22,"phases":280,"briefSummary":281,"conditions":282,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":285,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":144},"100499469","phase-4-trial-comparing-conventional-antibiotic-strategies-versus-regimens-guided-by-epidemiological-surveillance-in-infected-patients-with-cirrhosis-survicstudy-100499469","NCT05783661","Trial Comparing Conventional Antibiotic Strategies Versus Regimens Guided by Epidemiological Surveillance in Infected Patients With Cirrhosis (SURVIC_STUDY)","Randomized Controlled Trial Comparing Conventional Antibiotic Strategies Versus Regimens Guided by Epidemiological Surveillance in Infected Patients With Cirrhosis","SURVIC","Inclusion Criteria:\n\n1. Cirrhotic patients with acute decompensation aged ≥18 years.\n2. Proven or suspected bacterial infection requiring antibiotic therapy (diagnosis will be established according to local guidelines, Appendix 1).\n3. Signed informed consent or consent given by their legal representatives or close relatives.\n\nExclusion Criteria:\n\n1. Bacterial infection lasting for \\> 48 hours.\n2. Infection in a critically ill cirrhotic patient (ICU admission). In this population, epidemiological surveillance is standard clinical practice.\n3. Evidence of current locally advanced or metastatic malignancy (patients with hepatocellular carcinoma within the Milan criteria and non-melanocytic skin cancer can be included).\n4. Pregnant and\u002For breast-feeding woman.\n5. Patients who cannot provide prior informed consent and when there is documented evidence that the patient has no legal surrogate decision-maker and it appears unlikely that the patient will regain consciousness or sufficient ability to provide delayed informed consent.",{"count":279,"type":21},198,[103],"Study to comparing conventrional antibiotic strategies versus regimens guided by epidemiological surveillance in infected patients with cirrhosis.",[27,283],"Bacterial Infections","2024-09-26",{"date":286,"type":32},"2024-09-27",{"date":288,"type":32},"2023-12-11",{"date":290,"type":21},"2026-08",{"name":292,"class":39},"Eva Bonfill",{"id":294,"slug":295,"hasResults":11,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":299,"eligibilityCriteria":300,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":301,"targetDuration":4,"studyType":22,"phases":303,"briefSummary":305,"conditions":306,"keywords":4,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":308,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":4},"100557110","phase-3-fecal-microbiome-transplantation-in-cirrhosis-trial-in-patients-with-decompensated-cirrhosis-100557110","NCT06533852","Fecal Microbiome Transplantation in Cirrhosis: Trial in Patients With Decompensated Cirrhosis","Fecal Microbiome Transplantation in Cirrhosis: Randomized, Double-blinded, Placebo-Controlled Trial in Patients With Decompensated Cirrhosis","LiverGut","Inclusion Criteria:\n\n1. Age ≥ 18 years old.\n2. Cirrhosis defined by standard clinical criteria, ultrasonographic findings and\u002For histology. Cirrhosis of any etiology may be included except from patients with cirrhosis due to autoimmune hepatitis, and patients with cirrhosis due to cholestatic liver disease can only be included in the study if they present clinical decompensation of cirrhosis (i.e. ascites).\n3. Child-Pugh B or C patients (7- up to 12 points).\n4. Women of child-bearing potential\\* must have a negative pregnancy test in serum before the inclusion in the study and agree to use highly effective contraceptive methods during the study. Highly effective contraceptive methods will include: intrauterine device, bilateral tubal occlusion, vasectomized partner and sexual abstinence\\*\\* (only if refraining from heterosexual intercourse during the period of twelve months). Hormonal contraceptive methods will be avoided due to the risk of adverse events and impairment of liver function.\n\nExclusion Criteria:\n\n1. Previous history of gastrointestinal surgery or colorectal cancer.\n2. Patients with previous history of intestinal obstruction or those who are at increased risk of this complication.\n3. Active Clostridium Difficile infection.\n4. Patients on treatment with non-selective beta-blockers for \\\u003C3 month or without stable doses.\n5. Patients on treatment with any immunosuppressive drugs.\n6. Patients on antiviral therapy for HCV or those who have received it within the last 12 months.\n7. Patients on antiviral therapy for HBV therapy for \\\u003C 12 months.\n8. Patients with hepatocellular carcinoma, except for patients with early HCC (BCLC-0 or BCLC-A) or patients with previous history of HCC and absence of recurrence 2 years after treatment.\n9. Patients admitted to the hospital for acute decompensation of the disease. These patients could be included after discharged as long as they do not present any of the following events:\n\n   1. Bacterial infection within 10 days before study inclusion.\n   2. Gastrointestinal bleeding within 10 days before study inclusion.\n   3. Current overt hepatic encephalopathy, defined as grade II-IV hepatic encephalopathy according to the New-Haven classification.\n10. Patients with ACLF according to the criteria published by Moreau et al. (Appendix 1).\n11. Severe alcoholic hepatitis requiring corticosteroid therapy (MELD \\> 20) in the last 6 months.\n12. Patients with active alcohol consumption of more than 21 units per week.\n13. HIV infection.\n14. Patients with a history of significant extra hepatic disease with impaired short-term prognosis, including congestive heart failure New York Heart Association Grade III\u002FIV, COPD GOLD \\>2, chronic kidney disease with serum creatinine \\>2mg\u002FdL or under renal replacement therapy.\n15. Patients with current extra hepatic malignancies including solid tumours and hematologic disorders.\n16. Patients with previous organ transplantation.\n17. Pregnancy or breastfeeding.\n18. Patients included in other clinical trials in the month before inclusion.\n19. Patients with mental incapacity, language barrier, bad social support or any other reason considered by the investigator precluding adequate understanding, cooperation or compliance in the study.\n20. Refusal to give informed consent.",{"count":302,"type":21},190,[304],"PHASE3","This is a phase III, multicenter, double-blind, placebo-controlled, randomized clinical trial to evaluate the safety and efficacy of Fecal Microbiota Transplantation (FMT) from healthy subjects to patients with decompensated cirrhosis.",[27],"2024-07-30",{"date":309,"type":32},"2024-08-01",{"date":311,"type":21},"2024-12",{"date":313,"type":21},"2028-05",{"name":315,"class":316},"Consorcio Centro de Investigación Biomédica en Red (CIBER)","OTHER_GOV",{"id":318,"slug":319,"hasResults":11,"nctId":320,"briefTitle":321,"officialTitle":322,"acronym":4,"eligibilityCriteria":323,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":324,"targetDuration":4,"studyType":22,"phases":326,"briefSummary":327,"conditions":328,"keywords":4,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":4},"100539664","a-clinical-trial-evaluating-the-safety-tolerability-and-preliminary-efficacy-of-hcl001-cell-injection-homologous-allogeneic-hepatocytes-in-patients-with-decompensated-cirrhosis-100539664","NCT06306781","A Clinical Trial Evaluating the Safety, Tolerability, and Preliminary Efficacy of HCL001 Cell Injection (Homologous Allogeneic Hepatocytes) in Patients With Decompensated Cirrhosis","Clinical Trial Evaluating the Efficacy of Homologous Allogeneic Hepatocytes in Patients With Decompensated Cirrhosis","Inclusion Criteria:\n\n* When signing the informed consent form, individuals between the ages of 18 to 75 years (inclusive, including the boundary values) are eligible, and there are no restrictions based on gender.\n* According to the \"Guidelines for the Diagnosis and Treatment of Cirrhosis (2019 Edition)\", a diagnosis of decompensated cirrhosis is made.\n* A Child-Pugh score of 7-12 points (including the threshold) is classified as \\[insert the corresponding classification as per the provided appendix\\].\n* An ECOG performance status score of 0-2 or a Karnofsky Performance Status (KPS) score greater than 60 is considered \\[insert the corresponding classification or interpretation\\].\n* A safe vascular access that allows for hepatic intra-arterial catheterization and angiography\n* If screening for patients with hepatitis B or C-related cirrhosis, the viral load should be ≤1000 IU\u002FmL for HBV-DNA and ≤15 IU\u002FmL for HCV-RNA. For patients with alcoholic cirrhosis, the abstinence period should be ≥6 months.\n* During screening, the serum ALT level should be ≤3 times the upper limit of normal (ULN).\n* Understand and adhere to the research process, voluntarily participate, and sign the informed consent form (the informed consent form is to be voluntarily signed by myself or a legally authorized representative).\n\nExclusion Criteria:\n\n* Allergic individuals, especially those allergic to any component of HCL001 cell injection or its excipients.\n* Individuals with concurrent liver cancer or other malignant tumors.\n* Patients who are unable or unwilling to cooperate or comply with the requirements of the research protocol.\n* International Normalized Ratio (INR) \\>2.5 and platelet count (PLT) less than 30 x 10\\^9\u002FL.\n* Patients who have used anticoagulant or antiplatelet medications within the past week prior to screening.\n* Patients with a history of upper gastrointestinal bleeding or spontaneous peritonitis within the past four weeks prior to screening.\n* Patients who have experienced grade 3 or higher hepatic encephalopathy within the past three months prior to administering the medication.\n* Patients with severe dysfunction in vital organs such as the heart, lungs, brain, or kidneys, including: History of severe lung diseases such as severe emphysema, pulmonary embolism, or other lung conditions that significantly impact lung function. Significant history of heart disease that meets either of the following conditions: a. Decompensated heart failure (New York Heart Association \\[NYHA\\] class III-IV). b. Unstable angina. Chronic kidney disease, such as chronic nephritis, renal insufficiency, or uremia.\n* For patients with diabetes mellitus that is being treated but not effectively controlled, it typically refers to those with a glycated hemoglobin (HbA1c) level of ≥8%.\n* Patients with severe coagulation dysfunction or bleeding disorders, such as hemophilia, as well as those with severe jaundice indicated by a serum total bilirubin level of ≥171 μmol\u002FL.\n* This includes pregnant or lactating women, as well as individuals who are unable or unwilling to follow the researcher's guidance in using the approved contraceptive measures during the study period and for 6 months after the study ends.\n* Those who have received stem cell therapy in the past, or who are currently participating in another interventional clinical trial or have been enrolled in one within the past 3 months, are excluded from screening.\n* HIV positive\n* Presence of active infection during screening\n* The researchers consider any other factors that are not suitable for trial inclusion.",{"count":325,"type":21},18,[24],"This study protocol is designed to evaluate the clinical efficacy, safety, and tolerability of HCL001 cell injection in the treatment of decompensated cirrhosis. The aim is to provide stronger evidence for the clinical application of HCL001 cell injection in the treatment of decompensated cirrhosis, thereby attempting to improve patients' survival and quality of life to meet the clinical needs for treating decompensated liver cirrhosis.",[27],"2024-03-10",{"date":331,"type":32},"2024-03-12",{"date":333,"type":21},"2024-03-30",{"date":335,"type":21},"2026-12-30",{"name":337,"class":39},"RenJi Hospital"]