National Database on Primary Biliary Cholangitis

Launched by UNIVERSITY OF MILANO BICOCCA · Nov 25, 2021

Keywords

ClinConnect Summary

This clinical trial is focused on understanding Primary Biliary Cholangitis (PBC), a rare liver disease that happens when the body’s immune system attacks the bile ducts in the liver. The goal of the study is to create a national database for PBC patients in Italy, which will help researchers gather important information about the disease and also store biological samples for future studies. This is the first time researchers will have a comprehensive look at how PBC affects people in Italy.

If you are at least 18 years old and have been diagnosed with PBC, you may be eligible to participate. To be diagnosed with PBC, you typically need to have certain liver enzyme levels that are higher than normal, specific antibodies in your blood, or certain features seen in liver tissue samples. Participating in this study means you would provide some information about your health and possibly some biological samples, which will help improve understanding and treatment of PBC. If you have any questions or concerns, the research team is there to help you through the process.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• All PBC patients living in Italy and aged at least 18 years can be included in the database. According to well-established criteria, PBC is diagnosed in subjects who fulfill two of the three of following criteria:
• • elevated alkaline phosphatase and /or GGT;
• • positive anti-mitochondrial autoantibodies (titer ≥ 1:40) or PBC-specific antinuclear antibodies (gp-210 and sp100);
• • characteristic histological features of florid bile ducts lesions and granulomatous lesion.
• Exclusion Criteria:
• • The patient has explicitly declared his/her unwillingness to participate to the study