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Not yet recruiting NCT07594990

The MAI-FOIE Cohort

— Observational Autoimmune Liver Diseases Immunological Mechanisms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Autoimmune Liver Diseases, Immunological Mechanisms. Basic parameters: from 10 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Cohorte Des Maladies Auto-Immunes du Foie

Overview

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

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.

Primary outcome measures

  • Identification of new immune, cellular and molecular markers in patients who respond and not respond to treatment [Time frame: 2 years]
Secondary outcome measures (1)
  • Understanding the molecular mechanisms of treatment efficacy and failure [Time frame: 2 years]

Eligibility criteria

AIH (Auto-Immune Hepatitis) patients :

Inclusion criteria

  • age≥10 years old
  • weight≥25kg
  • 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
  • signing of a written consent form for participation in the study and for the storage of biological samples research

Control patients :

  • age≥18 years old
  • weight≥37kg
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 13 centers
  • CHU d'Angers — Angers
  • CHU de Brest — Brest
  • AP-HP Beaujon — Clichy
  • CHD Vendée — La Roche-sur-Yon
  • CHU de Lille — Lille
  • Hospices Civils de Lyon — Lyon
  • CHU Nantes — Nantes
  • AP-HP Saint-Antoine — Paris
  • … and 5 more centers

Identifiers

NCT: NCT07594990 · RC24_0619 · 2026-A00236-45

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗