Clinical Trial

Study on Clinical and Pathological Features of Primary Biliary Cholangitis and Risk Factors Related to Disease Progression

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Summary
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. Large-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. This 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/Cox 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.
Trial Details
NCT Number NCT07733882
Lead Sponsor Beijing Municipal Administration of Hospitals
Conditions PBC
Enrollment 300 participants
Start Date 2026-08
Primary Completion 2027-07-01 (estimated)
Study Completion 2027-07-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-04