NCT05151809 National Database on Primary Biliary Cholangitis
| NCT ID | NCT05151809 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Milano Bicocca |
| Condition | Primary Biliary Cholangitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 6,000 participants |
| Start Date | 2019-09-19 |
| Primary Completion | 2029-01-24 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 6,000 participants in total. It began in 2019-09-19 with a primary completion date of 2029-01-24.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Primary biliary cholangitis (PBC) is a rare, autoimmune, cholestatic liver disease. No data about the disease epidemiology exist in Italy. Therefore this study aims to develop a national PBC patient database linked to a biological sample storage.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05151809 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Primary Biliary Cholangitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05151809 currently recruiting?
Yes, NCT05151809 is actively recruiting participants. Contact the research team at pietro.invernizzi@unimib.it for enrollment information.
Where is the NCT05151809 trial being conducted?
This trial is being conducted at Ancona, Italy, Bari, Italy, Bergamo, Italy, Bologna, Italy and 11 additional locations.
Who is sponsoring the NCT05151809 clinical trial?
NCT05151809 is sponsored by University of Milano Bicocca. The trial plans to enroll 6,000 participants.