NCT03146884

Swiss Autoimmune Hepatitis Cohort Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Fondazione Epatocentro Ticino · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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)

Conditions

• Hepatitis, Autoimmune
• Autoimmune Hepatitis

Timeline

• Start date: 2017-02-16
• Primary completion: 2030-12-31
• Completion: 2030-12-31
• First posted: 2017-05-10
• Last updated: 2025-08-18

Locations

20 sites across 1 country: Switzerland