Clinical trial NCT03146884: Swiss Autoimmune Hepatitis Cohort Study
Official title: Swiss Autoimmune Hepatitis Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis, Autoimmune
Lead sponsor: Fondazione Epatocentro Ticino
Sponsor class: OTHER
First posted: 2017-05-10
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with AIH, either type I or type II living in Switzerland

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)

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Disease course
timeFrame: 3 years
measure: Disease features
timeFrame: 3 years
measure: Response to treatment
timeFrame: 3 years
measure: Overall survival
timeFrame: 3 years
measure: Transplantation-free survival rate
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Lugano
country: Switzerland
facility: Fondazione Epatocentro Ticino
state: Ticino
city: Basel
country: Switzerland
facility: Gastroenterologie und Hepatologie Clarunis - Universitäres Bauchzentrum, Universitätsspital Basel
city: Basel
country: Switzerland
facility: Universitäts-Kinderspital beider Basel UKBB, Gastroenterologie&Ernährung
city: Bern
country: Switzerland
facility: Inselspital
city: Bern
country: Switzerland
facility: Kinderklinik, INSELSpital, Universität Bern, Pädiatrische Gastroenterologie, Hepatologie und Ernährung
city: Chur
country: Switzerland
facility: Kantonsspital Graubünden, Departement für Kinder- und Jugendmedizin
city: Geneve
country: Switzerland
facility: Hôpitaux Universitaires de Genève, Centre Suisse des Maladies du foie de l'Enfant- Département de l'Enfant et de l'Adolescent
city: Geneve
country: Switzerland
facility: Hôpitaux Universitaires de Genève, Service de Gastroentérologie & Hépatologie, Département des Spécialités
city: Lausanne
country: Switzerland
facility: CHUV Département femme-mère-enfant
city: Liestal
country: Switzerland
facility: Kantonsspital Baselland
city: Lugano
country: Switzerland
facility: EOC Ospedale Regionale di Lugano - Italiano
city: Luzern
country: Switzerland
facility: Kinderspital Luzern LUKS, Pädiatrische Gastroenterologie
city: Sankt Gallen
country: Switzerland
facility: Ostschweizer Kinderspital
city: Sankt Gallen
country: Switzerland
facility: Kantonsspital St.Gallen
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
city: Winterthur
country: Switzerland
facility: Kinderspital Winterthur, Klinik für Gastroenterologie & Hepatologie
city: Zurich
country: Switzerland
facility: Universitäts-Kinderspital Zürich - Eleonorenstiftung
city: Zurich
country: Switzerland
facility: Universitätsspital Zürich
Study officials:
affiliation: Fondazione Epatocentro Ticino
name: Benedetta Terziroli Beretta-Piccoli, MD
role: PRINCIPAL_INVESTIGATOR
References: