Clinical trial Recruiting at 1 site Observational Ages 1 Year and up

Creating a database for Autoimmune Hepatitis patients in Italy

Official title: Multicenter, Nationwide, Observational, Retrospective and Prospective Study Based on the Development of a Autoimmune Hepatitis Patient's Database Linked to a Biological Sample Storage

Run by University of Milano Bicocca · NCT06078098 · Data updated 2026-11-12

This study is creating a database to collect important health information about Autoimmune Hepatitis patients in Italy to better understand how the disease affects them.

Quick facts

Study typeObservational
Ages1 Year and up
SexAll
Enrollment10000 (estimated)
SponsorUniversity of Milano Bicocca
Academic / other
Locations1 site (Monza, MB)
StatusRecruiting
StartedMarch 29, 2023
Main results expectedMarch 29, 2034
Study endsMarch 29, 2034
Registry record updatedOctober 11, 2023
Trial IDNCT06078098 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are individuals aged one year and older diagnosed with Autoimmune Hepatitis living in Italy.

Probably not a fit

Patients who are unwilling to participate in the study will not benefit from this initiative.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to develop a comprehensive database for Autoimmune Hepatitis (AIH) patients in Italy, linking clinical information with biological sample storage. It will evaluate the incidence, prevalence, and disease course of AIH in individuals over one year old, addressing the lack of specific registries in the country. By employing both retrospective and prospective methodologies, the study seeks to provide a clearer understanding of the disease's epidemiology and its impact on patients' quality of life.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and management of Autoimmune Hepatitis, ultimately enhancing patient care and outcomes.

How similar studies have gone: While there have been few population-based studies on Autoimmune Hepatitis, this approach is relatively novel in Italy and aims to fill a significant gap in the existing research.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* All AIH patients living in Italy and aged at least 1 year can be included in the database.
* Willing and able to give informed consent prior to any study specific procedure being
* Diagnosis of AIH according to the most recent published guidelines (EASL)

Exclusion Criteria:

* Subject unwilling to participate at the study

Where it's running

  • Fondazione IRCCS San Gerardo dei Tintori
    Monza, Mb, Italy
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.