[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"decompensated-cirrhosis-of-liver\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:decompensated-cirrhosis-of-liver":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,45,75,104,128],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100626756","using-telemedicine-to-assist-in-the-clinical-care-of-patients-with-decompensated-cirrhosis-100626756",false,"NCT07439770","Using Telemedicine to Assist in the Clinical Care of Patients With Decompensated Cirrhosis","Inclusion Criteria:\n\n1. Patients with decompensated cirrhosis and a Child score of B or C\n2. Age: 18 years or older\n3. Must return for a follow-up visit at least every 3 months\n\nExclusion Criteria:\n\n1. Patients with active malignant tumors (those with a history of malignant tumors must have been cured for at least 2 years)\n2. Patients with an expected survival of less than one year","ALL","18 Years",{"count":18,"type":19},120,"ESTIMATED","INTERVENTIONAL",[22],"NA","The goal of this clinical trial is to learn if an integrated digital and telemedicine care model works to manage decompensated cirrhosis in patients. It will also learn about the impact of this model on healthcare resource consumption and patient quality of life. The main questions it aims to answer are:\n\n1. Does this telemedicine model lower the number of cirrhosis-related hospitalizations and emergency department visits?\n2. Does the model reduce medical expenses and improve disease outcomes compared to standard care?\n\nResearchers will compare the digital telemedicine care model (utilizing the NTUH-TPC platform and wearable devices) to standard health care to see if the digital approach effectively reduces hospital admissions and medical costs.\n\nParticipants will:\n\n1. Use the NTUH telehealth platform (NTUH-TPC) to access records and upload physiological, medical, and imaging data.\n2. Wear a smart watch for remote physiological monitoring. Receive continuous remote care and proactive follow-ups from case managers.",[25],"Decompensated Cirrhosis of Liver",[27,28,29,30,31,32],"decompensated cirrhosis","telemedicine","digital medicine","mobile health","prognosis","health care","NOT_YET_RECRUITING","2026-02-23",{"date":36,"type":37},"2026-02-27","ACTUAL",{"date":34,"type":19},{"date":40,"type":19},"2028-12-31",{"name":42,"class":43},"National Taiwan University Hospital","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":20,"phases":54,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":44},"100574875","phase-2-statin-and-beta-blocker-use-in-patients-with-decompensated-cirrhosis-100574875","NCT06764966","Statin and Beta Blocker Use in Patients With Decompensated Cirrhosis","A Pilot Study of Statin and Beta Blocker Use in Patients With Decompensated Cirrhosis","Inclusion Criteria:\n\n* Patients age of 18 years or older diagnosed with any form of decompensated liver disease defined as ascites, hepatic encephalopathy, or variceal bleed presenting at Charleston Area Medical Center (CAMC) Memorial Hospital or CAMC-Gastroenterology Liver Clinic\n* Currently on an non-selective beta-blockers agreeing to have their liver disease managed by CAMC-Gastroenterology Liver Clinic as an outpatient for the 12-month follow-up period.\n\nExclusion Criteria:\n\n* Any patient \\\u003C18 years of age\n* Patients with hepatocellular carcinoma\n* Patients with ongoing alcohol use (self-reported consumption of more than one alcoholic drink per week)\n* Patients exhibiting high-risk behaviors that could put them at risk for complications including IV substance use and history of medication non-adherence\n* Patients currently on statin therapy\n* Patients with a history of statin intolerance\n* Patients on the waitlist for liver transplantation\n* Patients taking medications with known drug interactions with statins\n* Patients not able to give informed consent or patients belonging to vulnerable categories as the Federal Regulations or Common Rule",{"count":53,"type":19},50,[55],"PHASE2","Decompensated cirrhosis (liver disease) occurs when liver function decreases to the extent that serious complications develop and can include internal bleeding, fluid buildup in the abdomen, or mental confusion. This reduced decreased liver function subsequently decreases life expectancy. There is a critical need for strategies to delay progression to decompensation and reduce the occurrence of serious complications. Currently, limited therapeutic options are available for managing decompensated liver disease, with beta-blockers (BB) being the only proven medication with significant benefits in preventing disease progression. Statins have been historically under- prescribed in cirrhosis due to concerns of liver damage. However, there is emerging evidence that statin use may be beneficial and able to lessen liver disease worsening, with studies demonstrating its safety. Thus, we aim to conduct a pilot randomized controlled trial (RCT) study of 50 subjects comparing the outcomes of decompensated cirrhotic patients receiving the statin, atorvastatin, and a non-selective beta-blocker (NSBB) versus those receiving NSBB plus placebo. Both groups will be followed for 12 months to investigate the feasibility, safety, and efficacy of combination therapy.",[58,59,25,60],"Decompensated Liver Cirrhosis","Cirrhosis","Decompensated Cirrhosis and Ascites",[62,63,64,65,59],"Decompensated Cirrhosis","Decompensated Liver Disease","Statins","Beta-Blockers","RECRUITING",{"date":68,"type":37},"2026-02-25",{"date":70,"type":37},"2025-09-09",{"date":72,"type":19},"2027-03",{"name":74,"class":43},"CAMC Health System",{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":103},"100581803","validation-of-new-prognostic-biomarkers-in-patients-with-decompensated-cirrhosis-100581803","NCT06855056","Validation of New Prognostic Biomarkers in Patients With Decompensated Cirrhosis","Validation of New Prognostic biomarkerRs in Patients With cirrhOsis diScharged After a hosPitalization Due to acutE deCompensation or acuTe-on-chronic Liver Failure","PROSPECT","Inclusion Criteria:\n\n1. Age between 18 and 80 years.\n2. Patients with decompensated cirrhosis admitted to hospital due to AD according to the EASL-CLIF criteria (rapid onset of ascites, hepatic encephalopathy, portal hypertensive- related gastrointestinal bleeding, bacterial infection, or any combination of these), including those who presented ACLF during hospitalization.\n3. Recovery from AD and expected to be discharged within the next 48 hours.\n\nExclusion Criteria:\n\n1. Admission for planned diagnostic or therapeutic procedures\n2. Active malignancy (except for hepatocellular carcinoma within the Milan criteria or nonmelanocytic skin cancer)\n3. Antiviral treatment for hepatitis C, B and delta initiated in the last 6 months or planned to be initiated in the following 6 months.\n4. HIV positive (except undergoing treatment and who do not exhibit clinical manifestations of AIDS).\n5. Ongoing alcohol use disorder with an expected low adherence to prescriptions as judged by physician\n6. Previous liver or other organ transplantation\n7. Patients with TIPS or other surgical porto-caval shunts\n8. Chronic organic renal failure stage IV and V or estimated Glomerular Filtration Rate \\\u003C20 ml\u002Fmin according to the MDRD equations\n9. Chronic heart failure NYHA class III or IV\n10. Pulmonary disease GOLD III or IV\n11. Patients with a history of significant extrahepatic disease with life expectancy \\\u003C6 months\n12. Severe psychiatric disorders\n13. Pregnancy and breast-feeding\n14. Expected low adherence to study protocol as judged by physician\n15. Patients who cannot provide written informed consent or refuse to participate","80 Years",{"count":85,"type":19},189,"OBSERVATIONAL","The study aims to test the effectiveness of new biomarkers (measurable molecules in our body) in predicting the health outcome of patients with liver cirrhosis discharged from the hospital after a serious complication of the disease",[89,25],"Liver Cirrhosis",[58,91,92,89,93],"Acute on Chronic Liver Failure (ACLF)","Liver Diseases","Biomarkers","2025-08-05",{"date":96,"type":37},"2025-08-06",{"date":98,"type":37},"2025-03-01",{"date":100,"type":19},"2026-09-30",{"name":102,"class":43},"European Foundation for Study of Chronic Liver Failure",9,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":111,"enrollmentInfo":112,"targetDuration":4,"studyType":20,"phases":114,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":44},"100588124","phase-2-droxidopa-to-increase-mean-arterial-pressure-in-decompensated-cirrhosis-patients-with-acute-kidney-injury-100588124","NCT06937307","Droxidopa to Increase Mean Arterial Pressure in Decompensated Cirrhosis Patients With Acute Kidney Injury","DROP-AKI","Inclusion Criteria:\n\n* Ability to provide informed consent by subject or legally authorized representative\n* Consent to blood and urine collection for biomarker analysis\n* Ability to take oral medications\n* At least 18 years of age\n* Hospitalized at Columbia University Irving Medical Center\n* Child-Pugh Score ≥ B7 cirrhosis (documented by imaging, biopsy, or clinical evidence)\n* KDIGO Stage 1 AKI or greater, defined as:\n* ≥0.3 mg\u002FdL increase in serum creatinine within 48 hours OR\n* ≥50% increase in serum creatinine from outpatient baseline\n* Mean arterial pressure ≤85 mmHg averaged over 24 hours prior to randomization\n* For women of childbearing potential: negative pregnancy test and agreement to use effective contraception\n\nExclusion Criteria:\n\n* Serum creatinine \\>4.0 mg\u002FdL or current renal replacement therapy\n* Age \\>70 years\n* Severe cardiovascular disease, including:\n* Unstable angina\n* Congestive heart failure requiring escalating medical therapy\n* Symptomatic peripheral vascular disease\n* Any cardiovascular condition deemed severe by investigator\n* Active gastrointestinal bleeding, defined as requiring ≥ 2 units of packed red blood cells during the screening period\n* Acute respiratory failure requiring more than 6L of Nasal Canula\n* Use of medications that could interact with droxidopa including:\n* MAOI inhibitors\n* Norepinephrine reuptake inhibitors\n* Other investigational drugs\n* Pregnancy or breastfeeding\n* Any episode of a SBP ≥ 180 mmHg or a DBP ≥ 120 mmHg on two measurements, 1 minute apart\n* Prior liver transplantation","70 Years",{"count":113,"type":19},75,[55],"This study tests whether a medication called droxidopa can help improve blood flow to the kidneys in people with liver cirrhosis who develop kidney problems while in the hospital. When someone with cirrhosis experiences kidney injury, having better blood pressure can help their kidneys recover. Droxidopa is an oral medication that may help raise blood pressure without requiring intensive care or invasive treatments. The study will compare droxidopa to a placebo (inactive pill) in 75 people hospitalized with cirrhosis and kidney injury. Participants will take either droxidopa or placebo pills for 28 days and be monitored for an additional 30 days. Researchers will measure changes in blood pressure and kidney function to determine if droxidopa is effective and safe for these patients. This research could identify a new treatment option for a serious complication of liver disease.",[117,59,25],"Acute Kidney Injury",[117,59,62],"2025-06-03",{"date":121,"type":37},"2025-06-04",{"date":123,"type":37},"2025-05-27",{"date":125,"type":19},"2027-12-31",{"name":127,"class":43},"Giuseppe Cullaro, MD",{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":83,"enrollmentInfo":135,"targetDuration":4,"studyType":20,"phases":137,"briefSummary":138,"conditions":139,"keywords":140,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":103},"100508033","phase-2-a-novel-combinatorial-therapy-with-albumin-and-enoxaparin-in-patients-with-decompensated-cirrhosis-at-high-risk-of-poor-outcome-combat-trial-100508033","NCT05895136","A Novel COMBinATorial Therapy With Albumin and Enoxaparin in Patients With Decompensated Cirrhosis at High-risk of Poor Outcome (COMBAT Trial).","COMBAT","Inclusion Criteria:\n\n1. Age between 18 and 80 years.\n2. Patients with decompensated cirrhosis admitted to hospital due to AD according to the EASL-CLIF criteria (rapid onset of ascites, hepatic encephalopathy, portal hypertensive-related gastrointestinal bleeding, bacterial infection, or any combination of these).\n3. CLIF-C AD score ≥ 45 at admission or at any time during hospital stay.\n4. Recovery from AD and expected to be discharged within the next 72 hours.\n\nExclusion Criteria:\n\n1. Diagnosis of acute-on-chronic liver failure (ACLF) grade 3 or higher according to the EASL-CLIF criteria at admission or at any time during the index hospitalization\n2. Admission for planned diagnostic or therapeutic procedures\n3. Recent acute bleeding (unless the cause has been effectively treated and there is no evidence of ongoing bleeding for at least 5 days)\n4. Chronic bleeding requiring periodic blood transfusions\n5. Presence of an ongoing acute complication of the disease (i.e. hepatic encephalopathy \\[grade III or IV\\])\n6. Conditions with a high risk of haemorrhage, including haemorrhagic diathesis not related to liver disease\n7. Patients with INR \\> 3.0\n8. Severe thrombocytopenia (\\\u003C30x10 9 \u002FL)\n9. Ongoing chronic anticoagulation therapy or indication for starting anticoagulation due to hepatic and non-hepatic conditions\n10. Ongoing anti-platelets therapy.\n11. Active malignancy (except for hepatocellular carcinoma within the Milan criteria or non-melanocytic skin cancer)\n12. Antiviral treatment for hepatitis C, B and delta initiated in the last 6 months or planned to be initiated in the following 6 months\n13. Ongoing alcohol use disorder with an expected low adherence to protocol as judged by physician\n14. Previous liver transplantation\n15. Patients with TIPS or other surgical porto-caval shunts\n16. Chronic organic renal failure stage IV and V or estimated Glomerular Filtration Rate \\\u003C30 ml\u002Fmin according to the MDRD equations\n17. Chronic heart failure NYHA class III or IV\n18. Pulmonary disease GOLD III or IV\n19. Patients with extrahepatic diseases with life expectancy \\\u003C6 months\n20. Severe psychiatric disorders\n21. Hypersensitivity to albumin preparations or to any of the excipients.\n22. Hypersensitivity to enoxaparin sodium, heparin or its derivatives, including other low molecular weight heparins (LMWH) or to any of the excipients\n23. History of immune mediated heparin-induced thrombocytopenia (HIT) within the past 100 days or in the presence of circulating antibodies\n24. Pregnancy and breast-feeding\n25. Expected low adherence to study protocol as judged by physician\n26. Patients who can't provide written informed consent or refusal to participate\n27. Participation in other concurrent clinical trials and within the prior 3 months from informed consent signature.",{"count":136,"type":19},90,[55],"The goal of this clinical trial is to determine primarily whether a combinatorial therapy based on the administration of human albumin and enoxaparin is safe and effective in patients with decompensated cirrhosis discharged from the hospital. The main questions it aims to answer are:\n\n* Is this combinatorial therapy safe and tolerable?\n* Is this combinatorial therapy effective?\n* does this combinatorial therapy cost more or less than standard medical therapy? Participants will attend to study visits in which several test will be performed to asses disease evolution while they are taking study medication.\n\nResearchers will compare experimental group treated with combinatorial therapy plus standard treatment with control group treated with standard treatment to see if there are differences in the responses to the questions raised above.",[89,25,91],[27,91,141,142,143,144],"Liver diseases","liver cirrhosis","Human Albumin","Enoxaparin","2025-03-14",{"date":147,"type":37},"2025-03-19",{"date":149,"type":37},"2024-07-01",{"date":151,"type":19},"2025-09",{"name":102,"class":43}]