Clinical Trial: Swiss Autoimmune Hepatitis Cohort Study
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]
Official Title: Swiss Autoimmune Hepatitis Cohort Study
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 Summary:
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)
Sponsor: Fondazione Epatocentro Ticino
Current Primary Outcome:
- Disease course [ Time Frame: 3 years ]Observing disease course
- Disease features [ Time Frame: 3 years ]Observing disease features in Swiss population and see if they are similar to other countries'
- Response to treatment [ Time Frame: 3 years ]
- Overall survival [ Time Frame: 3 years ]
- Transplantation-free survival rate [ Time Frame: 3 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Fondazione Epatocentro Ticino
Dates:
Date Received: May 8, 2017
Date Started: February 16, 2017
Date Completion: December 31, 2022
Last Updated: May 8, 2017
Last Verified: May 2017