Swiss Autoimmune Hepatitis Cohort Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03146884

Enrollment

500

Registered

2017-05-10

Start date

2017-02-16

Completion date

2030-12-31

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune Hepatitis, Hepatitis, Autoimmune

Keywords

Autoimmune Hepatitis, AIH, Cohort

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 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)

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* N/A

Design outcomes

Primary

Measure	Time frame	Description
Disease course	3 years	Observing disease course
Disease features	3 years	Observing disease features in Swiss population and see if they are similar to other countries'
Response to treatment	3 years	Observing response to treatment
Overall survival	3 years	Observing overall survival
Transplantation-free survival rate	3 years	Observing transplantation-free survival rate

Countries

Switzerland

Contacts

Primary ContactAndreas Cerny, Prof. Dr. med

andreas.cerny@hin.ch+41 91 910 6570

Outcome results