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