Swiss Autoimmune Hepatitis Cohort Study

Research project in which biological material is sampled and health-related personal data is further used and collected.

Coded data are used.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Hepatitis, Autoimmune Autoimmune Diseases Autoimmune Hepatitis Digestive System Diseases Hepatitis Hepatitis, Chronic Immune System Diseases Liver Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Epatocentro Ticino, Lugano, Canton Ticino, Switzerland

About this study

To collect high quality prospective data on a rare disease in order to elucidate epidemiology, natural history, response to treatment and outcome. In addition, a 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 AIH. In addition, the cohort will allow collaborations with reference networks on AIH abroad.

Measurements and procedures: Enrolment visit and one follow-up visit at least once a year are planned. An additional follow-up visit at 6 months postdiagnosis is planned for newly diagnosed patients.

Whole blood is collected for biobanking once a year Optionally, if available and collected during normal clinical procedures, liver fragments are obtained.

Number of subjects projected for the entire study (all sites combined): 500 (corresponding to 1/3 of the estimated global AIH population residing in Switzerland, assuming a disease prevalence of 20:100,000)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

diagnosis of AIH, either type I or type II
Only patients living in Switzerland

Exclusion criteria

Treatment and study plan

Primary outcomes

Disease course

Time frame: 3 years

Observing disease course
Disease features

Time frame: 3 years

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

Time frame: 3 years

Observing response to treatment
Overall survival

Time frame: 3 years

Observing overall survival
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]

+41 91 910 6570

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 18, 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.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting