Last reviewed · How we verify
NCT05151809: PBC322
National Database on Primary Biliary Cholangitis
trial testing Clinical information in Primary Biliary Cholangitis in 6,000 participants. Currently enrolling.
24 January 2029
Quick facts
| Lead sponsor | University of Milano Bicocca |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 6,000 |
| Start date | 19 September 2019 |
| Primary completion | 24 January 2029 |
| Estimated completion | 24 January 2029 |
| Sites | 55 locations across Italy |
Drugs / interventions tested
- Clinical information
Conditions studied
- Primary Biliary Cholangitis — all drugs for Primary Biliary Cholangitis →
Sponsor
University of Milano Bicocca
Who can join
18 and older, any sex, with Primary Biliary Cholangitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Deep learning helps discriminate between autoimmune hepatitis and primary biliary cholangitis.
Gerussi A, Saldanha OL, Cazzaniga G, Verda D, et al · · 2025 · cited 7× · PMID 39829723 · DOI 10.1016/j.jhepr.2024.101198 -
Automating liver biopsy segmentation with a robust, open-source tool for pathology research: the HOTSPoT model.
Cazzaniga G, L'Imperio V, Bonoldi E, Londoño MC, et al · · 2025 · cited 3× · PMID 40681745 · DOI 10.1038/s41746-025-01870-1
Verify or expand the search:
- PubMed search for NCT05151809
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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Other recruiting trials for Primary Biliary Cholangitis
Currently open trials in the same condition.
- NCT07449793 — Biochemical Response and Clinical Outcomes in Patients With PBC · recruiting
- NCT07282353 — A Study of CS0159 in Patients With PBC With Inadequate Response or Intolerance to UDCA · Phase 3 · recruiting
- NCT06730061 — A Study of Elafibranor in Adult Japanese Participants With Primary Biliary Cholangitis (PBC) · Phase 3 · active not recruiting
- NCT06447168 — A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholang · recruiting
- NCT06427395 — Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis · Phase 3 · recruiting
Other University of Milano Bicocca trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05151809 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Milano Bicocca
- Last refreshed: 25 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05151809.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing