Swiss Autoimmune Hepatitis Cohort Study

• Conditions: Hepatitis, Autoimmune

• Registration Number: NCT03146884
• Lead Sponsor: Fondazione Epatocentro Ticino

Brief Summary

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)

Study Timeline

• Study Start: 2017-02-16
• Study First Submitted: 2017-05-08
• Study First Submitted QC: 2017-05-08
• Study First Posted: 2017-05-10
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-04-20
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

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

Exclusion Criteria

• N/A

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (18)

Inselspital; 🇨🇭 Bern, Switzerland

Fondazione Epatocentro Ticino; 🇨🇭 Lugano, Ticino, Switzerland

Hôpitaux Universitaires de Genève, Centre Suisse des Maladies du foie de l'Enfant- Département de l'Enfant et de l'Adolescent; 🇨🇭 Geneve, Switzerland

Gastroenterologie und Hepatologie Clarunis - Universitäres Bauchzentrum, Universitätsspital Basel; 🇨🇭 Basel, Switzerland

Universitäts-Kinderspital beider Basel UKBB, Gastroenterologie&Ernährung; 🇨🇭 Basel, Switzerland

Kinderklinik, INSELSpital, Universität Bern, Pädiatrische Gastroenterologie, Hepatologie und Ernährung; 🇨🇭 Bern, Switzerland

Kantonsspital Baselland; 🇨🇭 Liestal, Switzerland

EOC Ospedale Regionale di Lugano - Italiano; 🇨🇭 Lugano, Switzerland

Kantonsspital St.Gallen; 🇨🇭 Sankt Gallen, Switzerland

Kantonsspital Graubünden, Departement für Kinder- und Jugendmedizin; 🇨🇭 Chur, Switzerland

Hôpitaux Universitaires de Genève, Service de Gastroentérologie & Hépatologie, Département des Spécialités; 🇨🇭 Geneve, Switzerland

Kinderspital Luzern LUKS, Pädiatrische Gastroenterologie; 🇨🇭 Luzern, Switzerland

CHUV Département femme-mère-enfant; 🇨🇭 Lausanne, Switzerland

Ostschweizer Kinderspital; 🇨🇭 Sankt Gallen, Switzerland

Kantonsspital Winterthur; 🇨🇭 Winterthur, Switzerland

Kinderspital Winterthur, Klinik für Gastroenterologie & Hepatologie; 🇨🇭 Winterthur, Switzerland

Universitäts-Kinderspital Zürich - Eleonorenstiftung; 🇨🇭 Zurich, Switzerland

Universitätsspital Zürich; 🇨🇭 Zurich, Switzerland