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
Trial opening soon.
Get NotifiedKey information
Age range
10 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
CHU d'Angers, Angers, France
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
-
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
-
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.
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.