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Swiss Autoimmune Hepatitis Cohort Study

F

Fondazione Epatocentro Ticino

Status

Enrolling

Conditions

Autoimmune Hepatitis
Hepatitis, Autoimmune

Study type

Observational

Funder types

Other

Identifiers

NCT03146884
SASL38 - Swiss AIH Cohort

Details and patient eligibility

About

Research project in which biological material is sampled and health-related personal data is further used and collected.

Coded data are used.

Full 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)

Enrollment

500 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • diagnosis of AIH, either type I or type II
  • Only patients living in Switzerland

Exclusion criteria

  • N/A

Trial contacts and locations

20

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Central trial contact

Andreas Cerny, Prof. Dr. med

Data sourced from clinicaltrials.gov

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