NCT02846896

Brief Summary

PBC is a rare, autoimmune, cholestatic liver disease with genetic and environmental pathogenetic factors. Data about epidemiology of PBC in Switzerland are completely lacking. Epidemiology can be a powerful tool in yielding important clues as to burden and etiology of diseases. In addition, the investigators study will be the first one carried out in the country on PBC, and therefore will raise disease awareness and create a network.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
501

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 27, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

August 19, 2025

Status Verified

August 1, 2025

Enrollment Period

9 months

First QC Date

July 25, 2016

Last Update Submit

August 14, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prevalence of PBC in Switzerland

    from 1.1.2005 until 31.12.2015

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

PBC patients living in Switzerland

You may qualify if:

  • PBC patients living in Switzerland

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Epatocentro Ticino

Lugano, 6900, Switzerland

Location

Related Publications (1)

  • Terziroli Beretta-Piccoli B, Stirnimann G, Cerny A, Semela D, Hessler R, Helbling B, Stickel F, Kalid-de Bakker C, Bihl F, Giostra E, Filipowicz Sinnreich M, Oneta C, Baserga A, Invernizzi P, Carbone M, Mertens J. Geoepidemiology of Primary Biliary Cholangitis: Lessons from Switzerland. Clin Rev Allergy Immunol. 2018 Apr;54(2):295-306. doi: 10.1007/s12016-017-8656-x.

MeSH Terms

Conditions

Liver Cirrhosis, Biliary

Condition Hierarchy (Ancestors)

Cholestasis, IntrahepaticCholestasisBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesLiver DiseasesLiver CirrhosisFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2016

First Posted

July 27, 2016

Study Start

December 1, 2015

Primary Completion

September 1, 2016

Study Completion

March 1, 2017

Last Updated

August 19, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations