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NCT Number: NCT07594990

The MAI-FOIE Cohort

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

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Key information

Age range

10 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU d'Angers, Angers, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Understanding the molecular mechanisms of treatment efficacy and failure

    Time frame: 2 years

    Combination of immunological, histological and therapeutic analysis

Study contacts

Contact information is provided by the study sponsor or research team.

Jérôme GOURNAY, MD

CONTACT

[email protected]

+33 2.40.08.31.52

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Collaborators

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

Registry information

Official study title

Cohorte Des Maladies Auto-Immunes du Foie

Important dates

Study start
2026
Primary completion
2028
Study completion
2038
First posted
May 19, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.