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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 3,000 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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. The 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.

Conditions

• Primary Biliary Cholangitis (PBC)
• Primary Biliary Cholangitis

Interventions

Type	Name	Description
OTHER	Only observation	No intervention is needed.

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-07-31
• Completion: 2028-01-31
• First posted: 2026-03-04
• Last updated: 2026-03-04

Locations

1 site across 1 country: China