Swiss Autoimmune Hepatitis Cohort Study

Hepatitis, Autoimmune Clinical Trial

Official title:

Swiss Autoimmune Hepatitis Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03146884
• Other study ID #: SASL38 - Swiss AIH Cohort
• Status: Recruiting
• Start date: February 16, 2017
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2022
• Source: Fondazione Epatocentro Ticino
• Contact: Benedetta Terziroli Beretta-Piccoli, MD
• Phone: +41919608503
• Email: benedetta.terziroli[@]hin.ch
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Coded data are used.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• diagnosis of AIH, either type I or type II

• Only patients living in Switzerland

Exclusion Criteria:

• N/A

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis, Autoimmune

Locations

Country	Name	City	State
Switzerland	Gastroenterologie und Hepatologie Clarunis - Universitäres Bauchzentrum, Universitätsspital Basel	Basel
Switzerland	Universitäts-Kinderspital beider Basel UKBB, Gastroenterologie&Ernährung	Basel
Switzerland	Inselspital	Bern
Switzerland	Kinderklinik, INSELSpital, Universität Bern, Pädiatrische Gastroenterologie, Hepatologie und Ernährung	Bern
Switzerland	Kantonsspital Graubünden, Departement für Kinder- und Jugendmedizin	Chur
Switzerland	Hôpitaux Universitaires de Genève, Centre Suisse des Maladies du foie de l'Enfant- Département de l'Enfant et de l'Adolescent	Geneve
Switzerland	Hôpitaux Universitaires de Genève, Service de Gastroentérologie & Hépatologie, Département des Spécialités	Geneve
Switzerland	CHUV Département femme-mère-enfant	Lausanne
Switzerland	Kantonsspital Baselland	Liestal
Switzerland	EOC Ospedale Regionale di Lugano - Italiano	Lugano
Switzerland	Fondazione Epatocentro Ticino	Lugano	Ticino
Switzerland	Kinderspital Luzern LUKS, Pädiatrische Gastroenterologie	Luzern
Switzerland	Kantonsspital St.Gallen	Sankt Gallen
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

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Epatocentro Ticino

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease course	Observing disease course	3 years
Primary	Disease features	Observing disease features in Swiss population and see if they are similar to other countries'	3 years
Primary	Response to treatment	Observing response to treatment	3 years
Primary	Overall survival	Observing overall survival	3 years
Primary	Transplantation-free survival rate	Observing transplantation-free survival rate	3 years