The MAI-FOIE Cohort

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: Not yet recruiting
• Conditions: Autoimmune Liver Diseases; Immunological Mechanisms

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

• Study Contact: Name: Jérôme GOURNAY, MD; Phone Number: +33 2.40.08.31.52; Email: Jerome.gournay@chu-nantes.fr

Study Locations

• France
  • Nantes, France
    • CHU Nantes
    • Principal Investigator: Jérôme GOURNAY
    • Contact: Jérôme GOURNAY, MD; Phone Number: +33 2.40.08.31.52; Email: Jerome.gournay@chu-nantes.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

How is the study designed?

Number of groups / cohorts

2

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	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	Combination of immunological, histological and therapeutic analysis	2 years

Collaborators and Investigators

• 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; Association Française pour l'Etude du Foie (AFEF); ALBI; FILFOIE; GIRCIGO; CR2TI-U1064; HEPATIM-GO network; CIC IMAD

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): May 30, 2028
• Study Completion (Estimated): May 30, 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): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: biomarkers; Cohort; pathophysiology; biocollection
• 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