National Database on Primary Biliary Cholangitis
PBC322
Multicenter, Nationwide, Observational, Retrospective and Prospective Study Based on the Development of a Patients Database Linked to a Biological Sample Storage
1 other identifier
observational
6,000
1 country
55
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2019
Longer than P75 for all trials
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 19, 2019
CompletedFirst Submitted
Initial submission to the registry
November 15, 2021
CompletedFirst Posted
Study publicly available on registry
December 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 24, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 24, 2029
July 25, 2025
July 1, 2025
9.4 years
November 15, 2021
July 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Phenotypes and sub-phenotypes of PBC Italian patients
Identify and define distinct phenotypes and sub-phenotypes of PBC patients at higher risk of disease progression.
Overall duration of the study (10 years)
Secondary Outcomes (3)
Response to UDCA therapy
Overall duration of the study (10 years)
Identification of factors influencing the progression of PBC
Overall duration of the study (10 years)
Safety and long-term efficacy of novel therapies
Overall duration of the study (10 years)
Study Arms (1)
PBC population residing in Italy
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: 1. elevated alkaline phosphatase and /or GGT; 2. positive anti-mitochondrial autoantibodies (titer ≥ 1:40) or PBC-specific antinuclear antibodies (gp-210 and sp100); 3. characteristic histological features of florid bile ducts lesions and granulomatous lesion.
Interventions
The investigators will recruit PBC patients and collect important clinical information and laboratory investigation, together with biological samples.
Eligibility Criteria
All the italian patients fulfilling the diagnostic criteria for Primary Biliary Cholangitis (European Association for the Study of the Liver. EASL Clinical Practice Guidelines: management of cholestatic liver diseases. J Hepatol. 2009 Aug;51(2):237-67) and aged at least 18.
You may qualify if:
- 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.
You may not qualify if:
- The patient has explicitly declared his/her unwillingness to participate to the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (55)
Ospedali riuniti di Ancona
Ancona, Italy
A.O.U. Consorziale - Policlinico Bari- UO Gastroenterologia
Bari, Italy
UO di gastroenterologia, Asst Papa Giovanni XXIII
Bergamo, Italy
Policlinico S. Orsola Malpighi- UO Medicina Interna
Bologna, Italy
Policlinico S.Orsola Malpighi- Ambulatorio di epatologia e gestione trapianto epatico
Bologna, Italy
Gastroenterologia, fisiopatologia e endoscopia digestiva, Azienda sanitaria dell'alto adige
Bolzano, Italy
Unità epatologica ed ecografia internistica a valenza dipartimentale, Fondazione Ospedaliera Poliambulanza
Brescia, Italy
UO di gastroenterologia, Spedali civili di Brescia
Brescia, Italy
UO epatologia, Azienda ospedaliero università di Cagliari Policlinico universitario Monserrato
Cagliari, Italy
Ospedale IRCCS Saverio De Bellis- UOC di Gastroenterologia 1
Castellana Grotte, Italy
UO epatologia Ospedale Garibaldi
Catania, Italy
UO di fisiopatologia digestiva, Azienda Ospedaliera Universitaria Mater Domini
Catanzaro, Italy
UO di gastroenterologia, Ospedale Valduce
Como, Italy
Azienda Socio Sanitaria Territoriale (ASST) di Cremona- UO Medicina Interna - Ambulatori di Epatologia
Cremona, Italy
Presidio Ospedaliero di Faenza- UO Medicina Interna
Faenza, Italy
UO Clinica Medica, Azienda Ospedaliera Universitaria Careggi Firenze
Florence, Italy
Centro C.U.R.E. Centro Universitario per la ricerca e la Cura delle Malattie Epatiche
Foggia, Italy
Ambulatorio di Malattie del Fegato, U.O. Medicina, ASST Valle Olona, Presidio di Gallarate
Gallarate, Italy
UO Clinica Gastroenterologica, Policlinico San Martino
Genova, Italy
Centro Medicina del Viaggiatore e delle Migrazioni, ASP Catanzaro, Presìdio Ospedaliero "Giovanni Paolo II"
Lamezia Terme, Italy
UO di epatologia clinica e biomolecolare, Università degli studi di Messina
Messina, Italy
University of Milano-Bicocca
Milan, 20126, Italy
Policlinico di Milano
Milan, Italy
UO di epatologia, Ospedale Niguarda Ca' Granda
Milan, Italy
UO di Epatologia, Ospedale San Giuseppe
Milan, Italy
UO epatologia, Istituto scientifico universitario San Raffaele
Milan, Italy
AOU di Modena- U.O. Gastroenterologia
Modena, Italy
Struttura Complessa di Medicina ad Indirizzo Metabolico Nutrizionale, Dipartimento Ospedaliero di Medicina Interna
Modena, Italy
Day Hospital e Ambulatorio di Epatoogia e Nutrizione Clinica, Fondazione Evangelica Villa Betania, Ospedale generale di Zona
Napoli, Italy
Ospedale policlinico Federico II di Napoli
Napoli, Italy
Università della Campania Luigi Vanvitelli di Napoli- Dipartimento di epato-gastroenterologia
Napoli, Italy
UO medicina ed epatologia, Ospedale maggiore della carità
Novara, Italy
UO di Gastroenterologia, Azienda ospedaliera di Padova
Padua, Italy
UO di Medicina Interna, Azienda Ospedaliera di Padova
Padua, Italy
UO gastroenterologia, Policlinico Paolo Giaccone
Palermo, Italy
Malattie infettive ed epatologia, Azienda ospedaliero universitaria di Parma
Parma, Italy
Day Hospital Internistico e ambulatorio di Epatologia, ASL Pescara
Pescara, Italy
UO epatologia, AOU pisana Cisanello
Pisa, Italy
S.C. Gastroenterologia, Ospedale di Pordenone, AS FO
Pordenone, Italy
Medicina clinica ed epatologia, Policlinico universitario campus bio-medico
Roma, Italy
Policlinico Universitario Fondazione Agostino Gemelli- UO di medicina interna
Roma, Italy
UO di Epatologia, Universita' di Roma Tor Vergata
Roma, Italy
UO di Gastroenterologia, Policlinico Umberto I
Roma, Italy
Medicina interna ed epatologia, Istituto clinico Humanitas
Rozzano, Italy
Università degli studi di Salerno
Salerno, Italy
SSD Epatologia, Fondazione Casa Sollievo della Sofferenza
San Giovanni Rotondo, Italy
UO di Gastroenterologia e Endoscopia Digestiva, Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Italy
Azienda Ospedale Universitaria di Sassari- UOC Medicina Interna
Sassari, Italy
S.C. Gastroenterologia, Azienda Ospedaliero-Universitaria Molinette
Torino, Italy
Gastroenterologia ed endoscopia digestiva, Azienda provinciale per i servizi sanitari
Trento, Italy
Ospedale regionale Ca' Foncello di Treviso- Unità operativa complessa di Gastroenterologia
Treviso, Italy
SC (UCO) Clinica Patologie del Fegato, Ospedale di Cattinara, ASU GI
Trieste, Italy
SOS di DPT Epatologia e Trapianti di Fegato, ASU FC
Udine, Italy
UO di gastroenterologia ed endoscopia digestiva, Azienda macchi, Asst sette laghi
Varese, Italy
Azienda Ospedaliera Universitaria Integrata Verona- UOC Gastroeneterologia A
Verona, Italy
Biospecimen
Biological samples are collected at time of recruitment and on a yearly basis (for blood, urine and stools).The collection of bile and liver tissue depends on the specific procedures (ERCP and liver biopsy) that are performed based on clinical needs.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 10 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 15, 2021
First Posted
December 9, 2021
Study Start
September 19, 2019
Primary Completion (Estimated)
January 24, 2029
Study Completion (Estimated)
January 24, 2029
Last Updated
July 25, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share