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

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.

Inclusion Criteria:

• Age above 18 years old, Male or Female,
• Diagnosis of PBC meeting the 2018 American Association for the Study of Liver Diseases (AASLD) Practice Guidelines criteria;
• Treatment with UDCA at a standard dose (13-15 mg/kg/day), with or without other second-line medications.

Exclusion Criteria:

• 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);
• Autoimmune Hepatitis (AIH); Primary Sclerosing Cholangitis (PSC); Suspected or confirmed hepatocellular carcinoma;
• Female subjects who is pregnant or breastfeeding during the study;
• History of other malignancies, including hematological tumors, solid tumors except hepatobiliary system;
• Poor adherence or inability to complete the study follow-up.