[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627527":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":27,"centralContacts":31,"locations":37,"responsibleParty":52,"collaborators":10,"id":55,"slug":10,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":10,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":10,"studyType":67,"phases":10,"briefSummary":68,"conditions":69,"keywords":72,"overallStatus":39,"whyStopped":10,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"RenJi Hospital","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1: AKP\u003C1*ULN",null,"Patients diagnosed with PBC whose AKP levels fall below the upper limit of normal (ULN) after 12 months of treatment.",[13],"Other: Only observation",{"label":15,"type":10,"description":16,"interventionNames":17},"Group 2: AKP\u003C1.67*ULN and >1*ULN","Patients diagnosed with PBC whose AKP levels are between 1\\* and 1.67\\*ULN after 12 months of treatment.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Group 3: AKP>1.67*ULN","Patients diagnosed with PBC whose AKP levels exceed 1.67\\*ULN after 12 months of treatment.",[13],[23],{"type":6,"name":24,"description":25,"armGroupLabels":26,"otherNames":10},"Only observation","No intervention is needed.",[9,15,19],[28],{"name":29,"affiliation":5,"role":30},"Xiong Ma, MD, PhD","PRINCIPAL_INVESTIGATOR",[32],{"name":33,"role":34,"phone":35,"phoneExt":10,"email":36},"Min Lian, MD, PhD","CONTACT","+8615800744783","sophialian24@163.com",[38],{"facility":5,"status":39,"city":40,"state":41,"zip":42,"country":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"RECRUITING","Shanghai","Shanghai Municipality","200001","China",{"type":45,"coordinates":46},"Point",[47,48],121.45806,31.22222,{"lat":48,"lon":47},[51],{"name":33,"role":34,"phone":35,"phoneExt":10,"email":36},{"type":30,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"ma xiong","Principal Investigator","100627527",false,"NCT07449793","Biochemical Response and Clinical Outcomes in Patients With PBC","Impact of Enhanced Biochemical Response on Clinical Outcomes in Patients With Primary Biliary Cholangitis: A Bidirectional Cohort Study","Inclusion Criteria:\n\n* Age above 18 years old, Male or Female,\n* Diagnosis of PBC meeting the 2018 American Association for the Study of Liver Diseases (AASLD) Practice Guidelines criteria;\n* Treatment with UDCA at a standard dose (13-15 mg\u002Fkg\u002Fday), with or without other second-line medications.\n\nExclusion Criteria:\n\n* Co-existing liver diseases, including but not limited to: Hepatitis C virus infection; Active Hepatitis B infection (patients who are HBsAg-negative and HBeAg-negative may be considered eligible per investigator assessment);\n* Autoimmune Hepatitis (AIH); Primary Sclerosing Cholangitis (PSC); Suspected or confirmed hepatocellular carcinoma;\n* Female subjects who is pregnant or breastfeeding during the study;\n* History of other malignancies, including hematological tumors, solid tumors except hepatobiliary system;\n* Poor adherence or inability to complete the study follow-up.","ALL","18 Years","85 Years",{"count":65,"type":66},3000,"ESTIMATED","OBSERVATIONAL","This study is a bidirectional cohort study. The investigators conduct a bidirectional cohort study utilizing a database in mainland China, continuously collecting demographics, clinical symptoms, and biochemical characteristics of diagnosed PBC patients.\n\nThe study aims to analyze the association between varying post-treatment alkaline phosphatase (AKP) levels and complication-free survival rates, with the objective to develop and validate a predictive survival model.",[70,71],"Primary Biliary Cholangitis (PBC)","Primary Biliary Cholangitis",[73,74,75,76,77,78,79,80],"Primary Biliary Cirrhosis","Cholangitis","Bile Duct Diseases","Biliary Tract Diseases","Digestive System Diseases","Cholangitis, Biliary","Cirrhosis, Biliary","Chronic Nonsuppurative Destructive Cholangitis","2026-02-26",{"date":83,"type":84},"2026-03-04","ACTUAL",{"date":86,"type":66},"2026-02-01",{"date":88,"type":66},"2028-01-31",{"name":5,"class":6},1]