National database for patients with Primary Biliary Cholangitis in Italy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Ospedali riuniti di Ancona
  Ancona, Italy Recruiting
• A.O.U. Consorziale - Policlinico Bari- UO Gastroenterologia
  Bari, Italy Recruiting
• UO di gastroenterologia, Asst Papa Giovanni XXIII
  Bergamo, Italy Recruiting
• Policlinico S. Orsola Malpighi- UO Medicina Interna
  Bologna, Italy Recruiting
• Gastroenterologia, fisiopatologia e endoscopia digestiva, Azienda sanitaria dell'alto adige
  Bolzano, Italy Recruiting
• Unità epatologica ed ecografia internistica a valenza dipartimentale, Fondazione Ospedaliera Poliambulanza
  Brescia, Italy Recruiting

+5 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Pietro Invernizzi, MD
• Email: pietro.invernizzi@unimib.it
• Phone: +39 039 233 2187

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Seladelpar and Cilofexor in Primary Biliary Cholangitis (PBC)

  This study tests whether combining seladelpar with cilofexor helps people with primary biliary cholangitis more than seladelpar alone or placebo.

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• Austrian PBC Registry

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  Recruiting Medical University of Vienna · Klagenfurt, Carinthia and 10 other locations · NCT07598669

• Biochemical response and health outcomes in people with primary biliary cholangitis

  We will follow adults with primary biliary cholangitis who are taking ursodeoxycholic acid (UDCA) to see if their alkaline phosphatase levels after treatment predict how long they stay free of complications.

  Recruiting RenJi Hospital · Shanghai, Shanghai Municipality · NCT07449793

• Saroglitazar Magnesium for PBC with incomplete UDCA response or intolerance

  This study tests whether Saroglitazar Magnesium can help people with primary biliary cholangitis who still have high alkaline phosphatase despite UDCA or cannot take UDCA.

  Recruiting Phase 3 Zydus Therapeutics Inc. · Lakewood Rch, Florida · NCT07424677

• CS0159 for primary biliary cholangitis when UDCA doesn't work or isn't tolerated.

  This test tries to see if taking CS0159 once daily helps adults with primary biliary cholangitis who have an inadequate response to or cannot tolerate UDCA.

  Recruiting at 39 sites Phase 3 Cascade Pharmaceuticals, Inc · Hefei, Anhui and 41 other locations · NCT07282353

• Saroglitazar Magnesium-V as add-on therapy for primary biliary cholangitis

  This trial tests whether Saroglitazar Magnesium-V, compared with placebo, can improve long-term clinical outcomes in adults with primary biliary cholangitis who are on UDCA.

  Recruiting at 3 sites Phase 3 Zydus Therapeutics Inc. · Marietta, Georgia and 2 other locations · NCT07216235

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.