Status:
RECRUITING
PBC Long-term Outcomes Study
Lead Sponsor:
Beijing Friendship Hospital
Conditions:
Primary Biliary Cholangitis (PBC)
Long-term Outcomes
Eligibility:
All Genders
Brief Summary
Primary biliary cholangitis (PBC) is an autoimmune liver disease predominantly affecting middle-aged women. While historically it was deemed rare, advancements in specific auto-antibody tests have led...
Detailed Description
This is a retrospective-prospective, multicenter cohort study that plans to enroll approximately 4,000 patients with PBC from ten centers across multiple provinces and cities nationwide of China.
Eligibility Criteria
Inclusion
- Diagnosis consistent with PBC.
- Willingness to participate, with informed consent obtained from the patient or legal representative (if the patient is deceased or cognitively impaired), and ability to adhere to follow-up.
Exclusion
- Co-existing chronic hepatitis B or C, drug-induced liver injury, autoimmune hepatitis, primary sclerosing cholangitis, or hereditary/metabolic liver diseases.
- Co-existingMalignancy or severe cardiac, pulmonary, renal, cerebral, or hematologic disorders expected to substantially shorten life expectancy.
- Incomplete baseline medical records or laboratory data.
Key Trial Info
Start Date :
May 18 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
4000 Patients enrolled
Trial Details
Trial ID
NCT07149675
Start Date
May 18 2025
End Date
December 31 2029
Last Update
September 2 2025
Active Locations (1)
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1
Liver Research Center, Beijing Friendship Hospital, Capital Medical University
Beijing, Select A State Or Province, China, 100069