Nationwide Observational Study on Primary Biliary Cholangitis in Italy with Patient Database and Biological Sample Collection

What this Trial Is About

Primary biliary cholangitis PBC is a rare autoimmune liver disease that causes chronic inflammation of the bile ducts, leading to serious liver damage if untreated. This research aims to create a national database of PBC patients in Italy linked to biological sample storage to improve understanding of the disease, especially in patients who do not respond well to current treatment. The study involves about 60 centers across Italy and focuses on the biology of PBC and disease progression. Participants will have their clinical and laboratory data collected at the start and then annually through electronic case report forms. Biological samples will also be gathered to study patients genes and immune system differences among various PBC subtypes. This observational study collects data from adult PBC patients diagnosed based on established clinical, antibody, or histological criteria. Throughout the 10-year study, researchers will analyze patient phenotypes, responses to ursodeoxycholic acid therapy, factors affecting disease progression, and the safety and effectiveness of new treatments. Participants will be monitored regularly, with their clinical profiles and biological data helping to support future research, clinical care, and drug development efforts for PBC.

National Database on Primary Biliary Cholangitis