Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 4:03 AM
Study NCT ID:
NCT07449793
Status:
RECRUITING
Last Update Posted:
2026-03-04
First Post:
2026-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biochemical Response and Clinical Outcomes in Patients With PBC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008105', 'term': 'Liver Cirrhosis, Biliary'}, {'id': 'D002761', 'term': 'Cholangitis'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}], 'ancestors': [{'id': 'D002780', 'term': 'Cholestasis, Intrahepatic'}, {'id': 'D002779', 'term': 'Cholestasis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2028-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-26', 'studyFirstSubmitDate': '2026-02-26', 'studyFirstSubmitQcDate': '2026-02-26', 'lastUpdatePostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of complication-free survival', 'timeFrame': '18 months', 'description': 'Complication-free survival, defined as survival without liver-related death caused by PBC, liver transplantation, or major liver-related complications (ascites, variceal bleeding, hepatic encephalopathy, or hepatocellular carcinoma) during follow-up.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Primary Biliary Cirrhosis', 'Cholangitis', 'Bile Duct Diseases', 'Biliary Tract Diseases', 'Digestive System Diseases', 'Cholangitis, Biliary', 'Cirrhosis, Biliary', 'Chronic Nonsuppurative Destructive Cholangitis'], 'conditions': ['Primary Biliary Cholangitis (PBC)', 'Primary Biliary Cholangitis']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This program will be conducted at a single medical center in Shanghai, Mainland China. The sample size of subjects will be 3000 PBC patients.', 'healthyVolunteers': False, 'eligibilityCriteria': '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/kg/day), 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.'}, 'identificationModule': {'nctId': 'NCT07449793', 'briefTitle': 'Biochemical Response and Clinical Outcomes in Patients With PBC', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'Impact of Enhanced Biochemical Response on Clinical Outcomes in Patients With Primary Biliary Cholangitis: A Bidirectional Cohort Study', 'orgStudyIdInfo': {'id': 'PBC2026CH001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1: AKP<1*ULN', 'description': 'Patients diagnosed with PBC whose AKP levels fall below the upper limit of normal (ULN) after 12 months of treatment.', 'interventionNames': ['Other: Only observation']}, {'label': 'Group 2: AKP<1.67*ULN and >1*ULN', 'description': 'Patients diagnosed with PBC whose AKP levels are between 1\\* and 1.67\\*ULN after 12 months of treatment.', 'interventionNames': ['Other: Only observation']}, {'label': 'Group 3: AKP>1.67*ULN', 'description': 'Patients diagnosed with PBC whose AKP levels exceed 1.67\\*ULN after 12 months of treatment.', 'interventionNames': ['Other: Only observation']}], 'interventions': [{'name': 'Only observation', 'type': 'OTHER', 'description': 'No intervention is needed.', 'armGroupLabels': ['Group 1: AKP<1*ULN', 'Group 2: AKP<1.67*ULN and >1*ULN', 'Group 3: AKP>1.67*ULN']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200001', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Min Lian, MD, PhD', 'role': 'CONTACT', 'email': 'sophialian24@163.com', 'phone': '+8615800744783'}], 'facility': 'RenJi Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Min Lian, MD, PhD', 'role': 'CONTACT', 'email': 'sophialian24@163.com', 'phone': '+8615800744783'}], 'overallOfficials': [{'name': 'Xiong Ma, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RenJi Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'After this observational study is recruited, we are welcome to share the basic demographics and clinical outcomes of recruited IPD.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'ma xiong', 'investigatorAffiliation': 'RenJi Hospital'}}}}