Swiss Autoimmune Hepatitis Cohort Study

August 14, 2025 updated by: Fondazione Epatocentro Ticino

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

Coded data are used.

Study Overview

Status

Recruiting

Conditions

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)

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • Recruiting
        • Gastroenterologie und Hepatologie Clarunis - Universitäres Bauchzentrum, Universitätsspital Basel
        • Contact:
      • Basel, Switzerland, 4031
        • Recruiting
        • Universitäts-Kinderspital beider Basel UKBB, Gastroenterologie&Ernährung
        • Contact:
      • Bern, Switzerland, 3010
      • Bern, Switzerland, 3010
        • Recruiting
        • Kinderklinik, INSELSpital, Universität Bern, Pädiatrische Gastroenterologie, Hepatologie und Ernährung
        • Contact:
      • Chur, Switzerland, 7000
        • Recruiting
        • Kantonsspital Graubunden
        • Contact:
      • Geneve, Switzerland, 1205
        • Recruiting
        • Hôpitaux Universitaires de Genève, Centre Suisse des Maladies du foie de l'Enfant- Département de l'Enfant et de l'Adolescent
        • Contact:
      • Geneve, Switzerland, 1205
        • Recruiting
        • Hôpitaux Universitaires de Genève, Service de Gastroentérologie & Hépatologie, Département des Spécialités
        • Contact:
      • Lausanne, Switzerland, 1011
        • Recruiting
        • CHUV Département femme-mère-enfant
        • Contact:
      • Lausanne, Switzerland, 1005
        • Recruiting
        • CHUV: Centre hospitalier universitaire vaudois
        • Contact:
      • Liestal, Switzerland, 4410
        • Recruiting
        • Kantonsspital Baselland
        • Contact:
      • Lucerne, Switzerland, 6000
        • Recruiting
        • Kinderspital Luzern LUKS, Pädiatrische Gastroenterologie
        • Contact:
      • Lugano, Switzerland, 6900
      • Luzern, Switzerland, 6000
        • Recruiting
        • Luzerner Kantonsspital
        • Contact:
      • Sankt Gallen, Switzerland, 9006
        • Recruiting
        • Ostschweizer Kinderspital
        • Contact:
      • Sankt Gallen, Switzerland, 9007
        • Recruiting
        • Kantonsspital St.Gallen
        • Contact:
      • Winterthur, Switzerland, 8400
        • Recruiting
        • Kantonsspital Winterthur
        • Contact:
      • Winterthur, Switzerland, 8400
        • Recruiting
        • Kinderspital Winterthur, Klinik für Gastroenterologie & Hepatologie
        • Contact:
      • Zurich, Switzerland, 8091
        • Recruiting
        • UniversitätsSpital Zürich
        • Contact:
      • Zurich, Switzerland, 8032
        • Recruiting
        • Universitäts-Kinderspital Zürich - Eleonorenstiftung
        • Contact:
    • Ticino
      • Lugano, Ticino, Switzerland, 6900
        • Recruiting
        • Fondazione Epatocentro Ticino
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with AIH, either type I or type II living in Switzerland

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Epatocentro Ticino

Investigators

  • Principal Investigator: Benedetta Terziroli Beretta-Piccoli, MD, Fondazione Epatocentro Ticino

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2017

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

May 8, 2017

First Submitted That Met QC Criteria

May 8, 2017

First Posted (Actual)

May 10, 2017

Study Record Updates

Last Update Posted (Actual)

August 18, 2025

Last Update Submitted That Met QC Criteria

August 14, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SASL38 - Swiss AIH Cohort

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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