[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"decompensated-cirrhosis-and-ascites\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:decompensated-cirrhosis-and-ascites":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100574875","phase-2-statin-and-beta-blocker-use-in-patients-with-decompensated-cirrhosis-100574875",false,"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","ALL","18 Years",{"count":19,"type":20},50,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27,28,29],"Decompensated Liver Cirrhosis","Cirrhosis","Decompensated Cirrhosis of Liver","Decompensated Cirrhosis and Ascites",[31,32,33,34,27],"Decompensated Cirrhosis","Decompensated Liver Disease","Statins","Beta-Blockers","RECRUITING","2026-02-23",{"date":38,"type":39},"2026-02-25","ACTUAL",{"date":41,"type":39},"2025-09-09",{"date":43,"type":20},"2027-03",{"name":45,"class":46},"CAMC Health System","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"100443577","phase-3-personalized-long-term-human-albumin-treatment-in-patients-with-decompensated-cirrhosis-and-ascites-100443577","NCT05056220","Personalized Long-term Human Albumin Treatment in Patients With Decompensated Cirrhosis and Ascites","A Randomized Multicentre, Double-Blinded and Placebo-Controlled, Trial of Human Albumin in the Treatment of Decompensated Cirrhosis Guided by the MICROB-PREDICT Biomarker","Inclusion Criteria:\n\n* Decompensated liver cirrhosis defined as Child-Pugh score 7-12\n* Clinical and\u002For ultrasound evidenced ascites\n* Age ≥ 18 years\n* At least five days since resolution of a decompensation event or any condition requiring hospitalisation\n\nExclusion Criteria:\n\n* Patients with acute or subacute liver failure without underlying cirrhosis\n* Patients with cirrhosis who develop decompensation in the postoperative period following partial hepatectomy\n* Refractory ascites as defined by the International Ascites Club\n* Existing TIPS inserted \\\u003C6 months ago\n* Portal vein thrombosis without signs of cavernous transformation or recanalization\n* Severe alcoholic hepatitis (Glasgow Alcoholic Hepatitis Score \\> 11)\n* Hepatic encephalopathy grade III-IV\n* Current, planned or previous treatment with direct antiviral agents for hepatitis C virus (HCV) in the last six months Contraindications for human albumin infusion (pulmonary oedema, hypersensitivity etc.)\n* Evidence of current malignancy except for non-melanocytic skin cancer and hepatocellular carcinoma within Barcelona Clinic Liver Cancer (BCLC)-0 or BCLC-A\n* Presence or history of severe extra-hepatic diseases (e.g.,chronic renal failure requiring hemodialysis, severe heart disease (NYHA \\> II); severe chronic pulmonary disease (GOLD Score ≥ C), severe neurological and psychiatric disorders, pulmonary arterial hypertension)\n* HIV positive or other condition associated with and\u002For requiring immunosuppression\n* Previous liver or other transplantation\n* Pregnancy\n* Breastfeeding\n* Patients who decline to participate, patients who cannot provide prior written informed consent due to other causes than hepatic encephalopathy or patients with hepatic encephalopathy who cannot provide prior written informed consent and when there is documented evidence that the patient has no legal surrogate decision maker or sufficient ability to provide delayed informed consent\n* Physician's denial (investigator considers that the patient will not adhere to the study protocol scheduled, e.g. in case of heavy drinking)\n* Participation in another study within 3 months prior to screening",{"count":56,"type":20},240,[58],"PHASE3","The goal of this clinical biomarker validation trial is to test the effect of a predictive biomarker panel to human albumin infusions in patients with liver cirrhosis and ascites. The main questions it aims to answer are:\n\n* If the predictive biomarker panel can identify patients who are likely to benefit from regular human albumin infusions\n* If the predictive biomarker panel can lower the number-needed-to-treat of regular human albumin infusions in patients with liver cirrhosis and ascites\n\nThe predictive biomarker panel will stratify patients into either a high- or low-expected effect of human albumin infusions. Hereafter are participants randomized into treatment arms.\n\nParticipants in the active treatment arm will receive regular human albumin infusions during a course of 6 months. Infusions will occur every 10th day for the duration of the study.\n\nResearchers will compare 20% human albumin infusions with regular 0.9% sodium chloride to identify the effects on the number of liver-related events.",[29],"2026-01-30",{"date":63,"type":39},"2026-02-03",{"date":65,"type":39},"2024-02-26",{"date":67,"type":20},"2026-09",{"name":69,"class":46},"Aleksander Krag",12]