Swiss Autoimmune Hepatitis Cohort Study

Hepatitis, Autoimmune Clinical Trial

Official title: Swiss Autoimmune Hepatitis Cohort Study

Status Recruiting

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.

Clinical Trial 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) ;

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis, Autoimmune

• NCT number: NCT03146884
• Study type: Observational [Patient Registry]
• Source: Fondazione Epatocentro Ticino
• Contact: Benedetta Terziroli Beretta-Piccoli, MD
• Phone: +41919608503
• Email: benedetta.terziroli@hin.ch
• Status: Recruiting
• Start date: February 16, 2017
• Completion date: December 31, 2022