Study of Biochemical Response and Outcomes in Adults With Primary Biliary Cholangitis Using a Bidirectional Cohort

What this Trial Is About

Researchers are conducting a bidirectional cohort study to understand outcomes in patients with Primary Biliary Cholangitis PBC by analyzing biochemical responses after treatment. The study focuses on the relationship between alkaline phosphatase AKP levels following treatment and the patients complication-free survival rates. The goal is to develop and validate a model that predicts survival based on these biochemical markers. Participants are grouped based on their AKP levels after 12 months of treatment those with AKP below the upper limit of normal ULN, those with AKP between 1 and 1.67 times the ULN, and those with AKP above 1.67 times the ULN. The study involves observation only, without additional interventions, and continuously collects demographic, clinical, and biochemical data. During the study, researchers will monitor participants for 18 months to measure the rate of complication-free survival. Data collection includes patient demographics, clinical symptoms, and biochemical tests related to PBC. The study will track outcomes over time to assess how differing biochemical responses relate to patient health and complications, with participation lasting through the follow-up period ending in early 2028.

Biochemical Response and Clinical Outcomes in Patients With PBC