Autoimmune Liver DiseasesNCT07594990
The MAI-FOIE Cohort
An observational study of Autoimmune Liver Diseases and Immunological Mechanisms, run by Nantes University Hospital at 13 sites in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Autoimmune Liver Diseases, Immunological Mechanisms
- How many people
- 800 participants
- Where
- 13 sitesFrance
- Study dates
- 1 Jun 2026to 30 May 2038
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- Positive HIV serology HBV infection Positive HCV serology and PCR Patients under guardianship or curatorship
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
France13 sites
CHU d'Angers
Angers
BOURSIER Jérôme, jeboursier@chu-angers.fr
CHU de Brest
Brest
Jean-Baptiste NOUSBAUM, jean-baptiste.nousbaum@chu-brest.fr
AP-HP Beaujon
Clichy
Audrey PAYANCE, audrey.payance@aphp.fr
CHD Vendée
La Roche-sur-Yon
Matthieu SCHNEE, matthieu.schnee@chd-vendee.fr
CHU de Lille
Lille
Alexandre LOUVET, alexandre.louvet@chu-lille.fr
Hospices Civils de Lyon
Lyon
Jérôme DUMORTIER, Jerome.dumortier@chu-lyon.fr
CHU Nantes
Nantes
Jérôme GOURNAY, MD, +33 2.40.08.31.52, Jerome.gournay@chu-nantes.fr
Jérôme GOURNAY
AP-HP Saint-Antoine
Paris
Sara LEMOINNE, sara.lemoinne@aphp.fr
CHU Poitiers
Poitiers
Christine SILVAIN, christine.silvain@chu-poitiers.fr
CHU de Rennes
Rennes
Edouard BARDOU-JACQUET, edouard.bardou-jacquet@chu-rennes.fr
CHU de Toulouse
Toulouse
Christophe BUREAU, Bureau.c@chu-toulouse.fr
CHU de Tours
Tours
Laure EL KRIEF, l.elkrief@chu-tours.fr
AP-HP Paul Brousse
Villejuif
Eleonora De MARTIN, eleonora.demartin@aphp.fr
About this study
Official title: 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
Read the 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.
- Keywords
- Cohort, biocollection, pathophysiology, biomarkers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (1)
Understanding the molecular mechanisms of treatment efficacy and failure
Combination of immunological, histological and therapeutic analysis
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion30 May 2028 (estimated)
- Study completion30 May 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune Liver DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Direction Générale de l'Offre de Soins, Institut National de la Santé Et de la Recherche Médicale, France, National Cancer Institute, France, French Association for the Study of the Liver, ALBI, FILFOIE, GIRCIGO, CR2TI-U1064, HEPATIM-GO network, CIC IMAD
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07594990
- Sponsor's protocol ID
- RC24_0619
- Other IDs
- 2026-A00236-45
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohorte Des Maladies Auto-Immunes du Foie
- ClinicalTrials.gov ID
- NCT07594990
- Acronym / sponsor ID
- RC24_0619
- Keywords
- Cohort, biocollection, pathophysiology, biomarkers
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Direction Générale de l'Offre de Soins, Institut National de la Santé Et de la Recherche Médicale, France, National Cancer Institute, France, French Association for the Study of the Liver, ALBI, FILFOIE, GIRCIGO, CR2TI-U1064, HEPATIM-GO network, CIC IMAD
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 30 May 2028 (estimated)
- Study completion
- 30 May 2038 (estimated)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (14 listed)
- 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 :
- signing of a written consent form for participation in the study and for the storage of biological samples research
- age≥18 years old
Key exclusion criteria (1 listed)
- Positive HIV serology HBV infection Positive HCV serology and PCR Patients under guardianship or curatorship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Understanding the molecular mechanisms of treatment efficacy and failure
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Liver Diseases and Immunological Mechanisms, run by Nantes University Hospital at 13 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jérôme GOURNAY, MD (+33 2.40.08.31.52, Jerome.gournay@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of new immune, cellular and molecular markers in patients who respond and not respond to treatment (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.