The MAI-FOIE Cohort

Cohorte Des Maladies Auto-Immunes du Foie

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07594990

Enrollment

800

Registered

2026-05-19

Start date

2026-06-01

Completion date

2038-05-30

Last updated

2026-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune Liver Diseases, Immunological Mechanisms

Keywords

Cohort, biocollection, pathophysiology, biomarkers

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

10 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Identification of new immune, cellular and molecular markers in patients who respond and not respond to treatment	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

Measure	Time frame	Description
Understanding the molecular mechanisms of treatment efficacy and failure	2 years	Combination of immunological, histological and therapeutic analysis

Countries

France

Contacts

CONTACTJérôme GOURNAY, MD

Jerome.gournay@chu-nantes.fr+33 2.40.08.31.52

Outcome results