[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pbc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pbc":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,75],{"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":4,"briefSummary":22,"conditions":23,"keywords":25,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100649266","study-on-clinical-and-pathological-features-of-primary-biliary-cholangitis-and-risk-factors-related-to-disease-progression-100649266",false,"NCT07733882","Study on Clinical and Pathological Features of Primary Biliary Cholangitis and Risk Factors Related to Disease Progression","原发性胆汁性胆管炎临床、病理特征及病情进展相关危险因素研究","Inclusion Criteria:\n\n1. Met the diagnostic criteria for PBC according to the Guidelines for the Diagnosis and Treatment of Primary Biliary Cholangitis (2021) and the Guidelines for the Diagnosis and Treatment of Primary Biliary Cholangitis (2025 Edition), satisfying at least two of the following three criteria: ① biochemical evidence of cholestasis (elevated ALP and\u002For GGT) with imaging excluding extrahepatic or intrahepatic large bile duct obstruction; ② positive AMAs\u002FAMA-M2 or positivity for other PBC-specific autoantibodies (anti-gp210 or anti-sp100); ③ histologic evidence of non-suppurative destructive cholangitis and small bile duct destruction. (2) Underwent liver biopsy with a complete pathological report. (3) Had complete clinical data with missing values for key variables not exceeding 20%.\n\nExclusion Criteria:\n\n1. Concomitant other liver diseases, such as chronic hepatitis B, hepatitis C, hepatitis D, hepatitis E, alcoholic liver disease, non-alcoholic fatty liver disease, drug-induced liver injury, autoimmune hepatitis, primary hemochromatosis, or Wilson's disease. (2) Concurrent non-hepatotropic viral infections causing liver injury, including Epstein-Barr virus, cytomegalovirus, and human immunodeficiency virus. (3) Concurrent liver malignancy. (4) Age \\\u003C 18 years. (5) Severely incomplete clinical data with missing values for key variables exceeding 20%.","ALL","18 Years",{"count":19,"type":20},300,"ESTIMATED","OBSERVATIONAL","Primary biliary cholangitis (PBC) is a chronic autoimmune intrahepatic cholestatic liver disease characterized by progressive, non-suppurative, destructive cholangitis, potentially leading to fibrosis, cirrhosis, and liver failure. It predominantly affects middle-aged and elderly women, with highly variable progression rates: some patients remain stable long-term, while others rapidly develop portal hypertension and decompensation. Early risk factor identification and accurate risk stratification are essential for improving prognosis.\n\nLarge-scale, multi-dimensional (clinical-pathological-laboratory) studies on PBC progression risk factors in the Chinese population remain scarce. The associations of histological stage, autoantibody profiles, and biochemical response with prognosis require further clarification.\n\nThis retrospective observational study will enroll PBC patients with histologically confirmed diagnosis via liver biopsy at Beijing Ditan Hospital, Capital Medical University, from January 2015 to June 2026. We will systematically analyze clinical, laboratory, autoantibody, and pathological features. Univariate and multivariate logistic\u002FCox regression will be used to identify independent risk factors, aiming to establish a progression risk prediction model tailored to Chinese PBC patients. This model will support early identification of high-risk individuals and guide personalized treatment and follow-up strategies in clinical practice.",[24],"PBC",[26,27,28],"Primary Biliary Cholangitis (PBC)","Disease progression","Risk factors","NOT_YET_RECRUITING","2026-08-03",{"date":32,"type":33},"2026-08-04","ACTUAL",{"date":35,"type":20},"2026-08",{"date":37,"type":20},"2027-07-01",{"name":39,"class":40},"Beijing Municipal Administration of Hospitals","OTHER_GOV",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":74},"100443111","phase-2-a-study-to-evaluate-efficacy-and-safety-of-an-investigational-drug-named-volixibat-in-patients-with-itching-caused-by-primary-biliary-cholangitis-100443111","NCT05050136","A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis","A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients With Primary Biliary Cholangitis","VANTAGE","Inclusion Criteria:\n\n* Provide signed informed consent at the screening visit as well as comply with all study visits and requirements through the end of the study\n* Male or female, age ≥18 years at the screening visit\n* Confirmed diagnosis of PBC in line with the AASLD guidelines\n* UDCA, anti-pruritic medication and PPAR agonist use will be allowed if meeting additional criteria\n* Qualified pruritus associated with PBC as assessed by Adult ItchRO\n\nExclusion Criteria:\n\n* Pruritus associated with an etiology other than PBC\n* Evidence or clinical suspicion of decompensated cirrhosis or a history of decompensation events\n* Current symptomatic cholelithiasis or inflammatory gallbladder disease\n* History of small bowel surgery\u002Fresection impacting the terminal ileum that may disrupt the enterohepatic circulation.\n* Evidence, history, or suspicion of other liver diseases; PBC patients with AIH are not excluded\n* History of Liver transplantation",{"count":51,"type":20},260,"INTERVENTIONAL",[54],"PHASE2","The purpose of this clinical research study is to learn more about the use of the study medicine, volixibat, for the treatment of pruritus (itching) associated with Primary Biliary Cholangitis (PBC), and to assess the possible impact on the disease progression of PBC.",[57,24],"Primary Biliary Cholangitis",[59,24,60,61,57,62],"Pruritus","Itching","Cholangitis","Hepatobiliary disorders","RECRUITING","2026-05-12",{"date":66,"type":33},"2026-05-14",{"date":68,"type":33},"2021-09-22",{"date":70,"type":20},"2027-07",{"name":72,"class":73},"Mirum Pharmaceuticals, Inc.","INDUSTRY",130,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":81,"targetDuration":83,"studyType":21,"phases":4,"briefSummary":84,"conditions":85,"keywords":86,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":99},"100297047","swiss-primary-biliary-cholangitis-cohort-study-100297047","NCT03146910","Swiss Primary Biliary Cholangitis Cohort Study","Inclusion Criteria:\n\n* diagnose of Primary biliary cholangitis (according to EASL Clinical Practice Guidelines: management of cholestatic liver diseases).\n* Subjects with isolated anti-mitochondrial antibodies and\u002For isolated PBC-specific anti-nuclear antibodies are also included\n* Patients\u002Fsubjects aged at least 18 years and living in Switzerland are included\n\nExclusion Criteria:\n\n* N\u002FA",{"count":82,"type":20},500,"10 Years","Research project in which biological material is sampled and health-related medical data is collected. In addition, already existing health-related medical data are used for further research. Coded data are used.",[24,57],[24,57,87,88],"Cohort","AILD","2025-08-13",{"date":91,"type":33},"2025-08-17",{"date":93,"type":33},"2017-02-15",{"date":95,"type":20},"2030-12-31",{"name":97,"class":98},"Fondazione Epatocentro Ticino","OTHER",13]