Swiss Autoimmune Hepatitis Cohort Study

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    500
  • sponsor
    Fondazione Epatocentro Ticino
Updated on 14 February 2021

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)

Details
Condition Autoimmune hepatitis
Clinical Study IdentifierNCT03146884
SponsorFondazione Epatocentro Ticino
Last Modified on14 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Gender: Male or Female
Do you have Autoimmune hepatitis?
Do you have any of these conditions: Do you have Autoimmune hepatitis??
Do you have any of these conditions: Do you have Autoimmune hepatitis??
diagnosis of AIH, either type I or type II
Only patients living in Switzerland

Exclusion Criteria

N/A
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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