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National database for patients with Primary Biliary Cholangitis in Italy

Multicenter, Nationwide, Observational, Retrospective and Prospective Study Based on the Development of a Patients Database Linked to a Biological Sample Storage

Observational University of Milano Bicocca · NCT05151809

This study is creating a national database for people in Italy with Primary Biliary Cholangitis to better understand the disease and improve treatment options.

Quick facts

Study typeObservational
Enrollment6000 (estimated)
Ages18 Years and up
SexAll
SponsorUniversity of Milano Bicocca Academic / other
Locations55 sites (Ancona and 54 other locations)
Trial IDNCT05151809 on ClinicalTrials.gov

What this trial studies

This observational study aims to create a national database for patients diagnosed with Primary Biliary Cholangitis (PBC) in Italy, linking clinical information with biological sample storage. PBC is a rare autoimmune liver disease that can lead to severe complications if untreated. The study seeks to address significant gaps in knowledge regarding the disease's epidemiology, sub-phenotypes, and biomarkers for disease progression. By utilizing advanced -omics technologies, the research aims to enhance understanding of PBC and pave the way for personalized medicine approaches.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older living in Italy who have been diagnosed with Primary Biliary Cholangitis.

Not a fit: Patients who are unwilling to participate in the study will not benefit from the findings or advancements that may arise from this research.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnosis, treatment strategies, and personalized care for patients with Primary Biliary Cholangitis.

How similar studies have performed: While there have been advancements in understanding PBC, this specific approach to creating a national database is novel and untested in Italy.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Ancona and 54 other locations

+5 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Primary Biliary CholangitisDisease phenotypesNational Database
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.