Swiss Primary Biliary Cholangitis Cohort Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03146910

Enrollment

500

Registered

2017-05-10

Start date

2017-02-15

Completion date

2030-12-31

Last updated

2025-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PBC, Primary Biliary Cholangitis

Keywords

PBC, Primary Biliary Cholangitis, Cohort, AILD

Brief summary

Research project in which biological material is sampled and health-related medical data is collected. In addition, already existing health-related medical data are used for further research. Coded data are used.

Detailed description

Enrolment visit and one follow-up visit at least once a year are planned. Whole blood is collected for biobanking once a year. Optionally, if available and collected during normal clinical procedures, liver fragments are obtained. To collect high quality prospective data on a rare disease in order to elucidate epidemiology, natural history, response to treatment and outcome. In addition, the biobank allows addressing specific scientific issues on a variety of open questions. The cohort will provide a platform for carrying out scientific research projects on PBC. In addition, the cohort will allow collaboration with reference networks on PBC abroad.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Disease course	3 years	Observing disease course
Disease features	3 years	Observing disease features in Swiss population and see if they are similar to other countries'
Response to treatment	3 years	Observing response to treatment
Overall survival	3 years	Observing overall survival
Transplantation-free survival rate	3 years	Observing transplantation-free survival rate

Countries

Switzerland

Contacts

Primary ContactAndreas Cerny, Prof. Dr. med

andreas.cerny@hin.ch+41919106570

Outcome results