Swiss Autoimmune Hepatitis Cohort Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hepatitis, Autoimmune, Autoimmune Hepatitis. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
Research project in which biological material is sampled and health-related personal data is further used and collected. Coded data are used.
Detailed description
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)
Primary outcome measures
- Disease course [Time frame: 3 years]
- Disease features [Time frame: 3 years]
- Response to treatment [Time frame: 3 years]
- Overall survival [Time frame: 3 years]
- Transplantation-free survival rate [Time frame: 3 years]
Eligibility criteria
Inclusion criteria
- diagnosis of AIH, either type I or type II
- Only patients living in Switzerland
Exclusion criteria
- N/A
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Switzerland · 20 centers
- Fondazione Epatocentro Ticino — Lugano
- Gastroenterologie und Hepatologie Clarunis - Universitäres Bauchzentrum, Universitätsspita — Basel
- Universitäts-Kinderspital beider Basel UKBB, Gastroenterologie&Ernährung — Basel
- Inselspital — Bern
- Kinderklinik, INSELSpital, Universität Bern, Pädiatrische Gastroenterologie, Hepatologie u — Bern
- Kantonsspital Graubünden — Chur
- Hôpitaux Universitaires de Genève, Centre Suisse des Maladies du foie de l'Enfant- Départe — Geneva
- Hôpitaux Universitaires de Genève, Service de Gastroentérologie & Hépatologie, Département — Geneva
- … and 12 more centers
Identifiers
NCT: NCT03146884 · SASL38 - Swiss AIH Cohort