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Clinical Trials in Italy / NCT05151809
Recruiting Observational

National Database on Primary Biliary Cholangitis

NCT05151809 · tracked via the Priya Life Science Italy tracker
Sponsor
University of Milano Bicocca
Phase
Observational
Started
2019-09-19
Last updated
2025-07-25

Condition(s) studied

Primary Biliary Cholangitis

Investigational drug(s) / intervention(s)

Clinical information

Clinical information: The investigators will recruit PBC patients and collect important clinical information and laboratory investigation, together with biological samples.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (55)

FacilityCityRegionStatus
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
Policlinico S.Orsola Malpighi- Ambulatorio di epatologia e gestione trapianto epatico Bologna Italy Not Yet 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
UO di gastroenterologia, Spedali civili di Brescia Brescia Italy Not Yet Recruiting
UO epatologia, Azienda ospedaliero università di Cagliari Policlinico universitario Monserrato Cagliari Italy Recruiting
Ospedale IRCCS Saverio De Bellis- UOC di Gastroenterologia 1 Castellana Grotte Italy Recruiting
UO epatologia Ospedale Garibaldi Catania Italy Recruiting
UO di fisiopatologia digestiva, Azienda Ospedaliera Universitaria Mater Domini Catanzaro Italy Recruiting
UO di gastroenterologia, Ospedale Valduce Como Italy Recruiting
Azienda Socio Sanitaria Territoriale (ASST) di Cremona- UO Medicina Interna - Ambulatori di Epatologia Cremona Italy Recruiting
Presidio Ospedaliero di Faenza- UO Medicina Interna Faenza Italy Recruiting
UO Clinica Medica, Azienda Ospedaliera Universitaria Careggi Firenze Florence Italy Recruiting
Centro C.U.R.E. Centro Universitario per la ricerca e la Cura delle Malattie Epatiche Foggia Italy Recruiting
Ambulatorio di Malattie del Fegato, U.O. Medicina, ASST Valle Olona, Presidio di Gallarate Gallarate Italy Recruiting
UO Clinica Gastroenterologica, Policlinico San Martino Genova Italy Recruiting
Centro Medicina del Viaggiatore e delle Migrazioni, ASP Catanzaro, Presìdio Ospedaliero "Giovanni Paolo II" Lamezia Terme Italy Recruiting
UO di epatologia clinica e biomolecolare, Università degli studi di Messina Messina Italy Not Yet Recruiting
University of Milano-Bicocca Milan Italy Recruiting
Policlinico di Milano Milan Italy Recruiting
UO di epatologia, Ospedale Niguarda Ca' Granda Milan Italy Recruiting
UO di Epatologia, Ospedale San Giuseppe Milan Italy Recruiting
UO epatologia, Istituto scientifico universitario San Raffaele Milan Italy Recruiting
AOU di Modena- U.O. Gastroenterologia Modena Italy Recruiting
Struttura Complessa di Medicina ad Indirizzo Metabolico Nutrizionale, Dipartimento Ospedaliero di Medicina Interna Modena Italy Recruiting
Day Hospital e Ambulatorio di Epatoogia e Nutrizione Clinica, Fondazione Evangelica Villa Betania, Ospedale generale di Zona Naples Italy Not Yet Recruiting
Ospedale policlinico Federico II di Napoli Naples Italy Recruiting
Università della Campania Luigi Vanvitelli di Napoli- Dipartimento di epato-gastroenterologia Naples Italy Recruiting
UO medicina ed epatologia, Ospedale maggiore della carità Novara Italy Recruiting
UO di Gastroenterologia, Azienda ospedaliera di Padova Padova Italy Recruiting
UO di Medicina Interna, Azienda Ospedaliera di Padova Padova Italy Recruiting
UO gastroenterologia, Policlinico Paolo Giaccone Palermo Italy Recruiting
Malattie infettive ed epatologia, Azienda ospedaliero universitaria di Parma Parma Italy Recruiting
Day Hospital Internistico e ambulatorio di Epatologia, ASL Pescara Pescara Italy Recruiting
UO epatologia, AOU pisana Cisanello Pisa Italy Recruiting
S.C. Gastroenterologia, Ospedale di Pordenone, AS FO Pordenone Italy Recruiting
Medicina clinica ed epatologia, Policlinico universitario campus bio-medico Roma Italy Recruiting

+ 15 more sites — see the full list on the official registry below.

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Other trials for the same condition

Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis Recruiting
A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholangitis Who Are Receiving Ongoing Treatment Active, not recruiting
LEOPARD Prospective Validation Cohort 1 Recruiting
LEOPARD Training and Validation Data Collection Study Recruiting
Patients With Primary Biliary Cholangitis(PBC) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05151809 on ClinicalTrials.gov ↗ ← All trials in Italy