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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 2 May 2022
Main ID:  NCT03146910
Date of registration: 08/05/2017
Prospective Registration: No
Primary sponsor: Fondazione Epatocentro Ticino
Public title: Swiss Primary Biliary Cholangitis Cohort Study
Scientific title: Swiss Primary Biliary Cholangitis Cohort Study
Date of first enrolment: February 15, 2017
Target sample size: 500
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT03146910
Study type:  Observational [Patient Registry]
Study design:   
Phase: 
Countries of recruitment
Switzerland
Contacts
Name:     Benedetta Terziroli Beretta-Piccoli, MD
Address: 
Telephone: +41919608503
Email: benedetta.terziroli@hin.ch
Affiliation: 
Name:     Benedetta Terziroli Beretta-Piccoli, MD
Address: 
Telephone:
Email:
Affiliation:  Epatocentro Ticino
Key inclusion & exclusion criteria

Inclusion Criteria:

- diagnose of Primary biliary cholangitis (according to EASL Clinical Practice
Guidelines: management of cholestatic liver diseases).

- Subjects with isolated anti-mitochondrial antibodies and/or isolated PBC-specific
anti-nuclear antibodies are also included

- Patients/subjects aged at least 18 years and living in Switzerland are included

Exclusion Criteria:

- N/A



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Liver Cirrhosis, Biliary
Intervention(s)
Primary Outcome(s)
Overall survival [Time Frame: 3 years]
Disease course [Time Frame: 3 years]
Response to treatment [Time Frame: 3 years]
Disease features [Time Frame: 3 years]
Transplantation-free survival rate [Time Frame: 3 years]
Secondary Outcome(s)
Secondary ID(s)
SASL39 - Swiss PBC Cohort
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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