[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627527":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":27,"centralContacts":31,"locations":37,"responsibleParty":53,"collaborators":10,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":10,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":10,"studyType":69,"phases":10,"briefSummary":70,"conditions":71,"keywords":74,"overallStatus":39,"whyStopped":10,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"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,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"RECRUITING","Shanghai","Shanghai Municipality","200001","China","CN",{"type":46,"coordinates":47},"Point",[48,49],121.45806,31.22222,{"lat":49,"lon":48},[52],{"name":33,"role":34,"phone":35,"phoneExt":10,"email":36},{"type":30,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"ma xiong","Principal Investigator","100627527","biochemical-response-and-clinical-outcomes-in-patients-with-pbc-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":67,"type":68},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.",[72,73],"Primary Biliary Cholangitis (PBC)","Primary Biliary Cholangitis",[75,76,77,78,79,80,81,82],"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":85,"type":86},"2026-03-04","ACTUAL",{"date":88,"type":68},"2026-02-01",{"date":90,"type":68},"2028-01-31",{"name":5,"class":6},1]