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NCT Number: NCT03146910

Swiss Primary Biliary Cholangitis Cohort Study

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.

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Key information

Conditions

PBC Bile Duct Diseases Biliary Tract Diseases Cholestasis Cholestasis, Intrahepatic Digestive System Diseases Fibrosis Liver Cirrhosis Liver Cirrhosis, Biliary Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Primary Biliary Cholangitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Epatocentro Ticino, Lugano, Canton Ticino, Switzerland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Disease course

    Time frame: 3 years

    Observing disease course

  2. Disease features

    Time frame: 3 years

    Observing disease features in Swiss population and see if they are similar to other countries'

  3. Response to treatment

    Time frame: 3 years

    Observing response to treatment

  4. Overall survival

    Time frame: 3 years

    Observing overall survival

  5. Transplantation-free survival rate

    Time frame: 3 years

    Observing transplantation-free survival rate

Study contacts

Contact information is provided by the study sponsor or research team.

Andreas Cerny, Prof. Dr. med

CONTACT

[email protected]

+41919106570

Sponsors and collaborators

Lead sponsor

Fondazione Epatocentro Ticino

Other

Registry information

Important dates

Study start
2017
Primary completion
2030
Study completion
2030
First posted
May 10, 2017
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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