The MAI-FOIE Cohort

November 10, 2026 updated by: Nantes University Hospital

Cohorte Des Maladies Auto-Immunes du Foie

The MAI-FOIE cohort will be a French multicenter cohort with the development of a biobank including patients with autoimmune, metabolic and medicated liver diseases

Study Overview

Status

Recruiting

Conditions

Detailed Description

The MAI-FOIE cohort will be a prospective cohort of patients with autoimmune liver diseases followed up in 13 French centers. The multicentric nature of the cohort is a major asset, enabling the enrolment of a broad spectrum of patients, from those naïve to any immunomodulatory treatment to those refractory to therapies. The goal is to identify different treatment response profiles, markers of remission and markers of relapse risk after discontinuation of immunosuppressants in order to improve patient care.

Study Type

Observational

Enrollment (Estimated)

800

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

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

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients from 10 years old to patients without limit age, male or female, with Auto-Immune Hepatitis or Metabolic steatohepatitis or Drug induced Hepatitis

Description

AIH (Auto-Immune Hepatitis) patients :

Inclusion Criteria :

  1. age≥10 years old

  2. weight≥25kg

  3. AIH (with or without the presence of an overlap) whose diagnosis is validated by at least 2 of the following criteria :

    • ALT>2N or IgG>1.1N
    • Presence of autoantibodies : ANA (antinuclear), ML (anti-smooth muscle), SLA (anti-soluble liver antigen), LKM1 (anti-endoplasmic reticulum), LC1 (anti-liver cytosol)
    • Presence of interface hepatitis on biopsy

  4. signing of a written consent form for participation in the study and for the storage of biological samples research

Control patients :

  1. age≥18 years old

  2. weight≥37kg

  3. Patient with one of the following 3 conditions :

    • Primary Biliary Cholangitis
    • Metabolic steatohepatitis
    • Drug induced hepatitis

Exclusion Criteria :

Positive HIV serology HBV infection Positive HCV serology and PCR Patients under guardianship or curatorship

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

  • Observational Models: COHORT
  • Time Perspectives: PROSPECTIVE

Cohorts and Interventions

Group / Cohort
AIH patients

Patients of both sexes, over 10 years old, with an established diagnosis of AIH (Auto Immune Hepatitis) will be eligible for inclusion during a medical care visit.
Control patients

Patients of both sexes, over 18 years old, with an established diagnosis of Primary Biliary Cholangitis, Metabolic Steatohepatitis or Drug-Induced Hepatitis will be eligible for inclusion during a medical care visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of new immune, cellular and molecular markers in patients who respond and not respond to treatment
Time Frame: 2 years

Comparative studies of clinical, biological, genetic (HLA typing) parameters and result from omics analysis of patients groups classified according to their response to treatment and disease progression
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Understanding the molecular mechanisms of treatment efficacy and failure
Time Frame: 2 years

Combination of immunological, histological and therapeutic analysis
2 years

Collaborators and Investigators

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

Sponsor

Nantes University Hospital

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France
National Cancer Institute, France
Direction Générale de l'Offre de Soins
ALBI
FILFOIE
GIRCIGO
CR2TI-U1064
HEPATIM-GO network
CIC IMAD
French Association for the Study of the Liver

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)

June 25, 2026

Primary Completion (Estimated)

June 24, 2038

Study Completion (Estimated)

June 24, 2038

Study Registration Dates

First Submitted

May 11, 2026

First Submitted That Met QC Criteria

May 11, 2026

First Posted (Actual)

May 19, 2026

Study Record Updates

Last Update Posted (Actual)

November 13, 2026

Last Update Submitted That Met QC Criteria

November 10, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RC24_0619
  • 2026-A00236-45 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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