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800-Patient study aims to unlock secrets of autoimmune liver disease

NCT ID NCT07594990

Knowledge-focused Sponsor: Nantes University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This French study will collect medical data and biological samples from 800 people with autoimmune liver diseases. Researchers hope to identify new markers that explain why some patients respond well to treatment while others do not. The goal is to better understand the immune mechanisms behind these diseases, which could eventually lead to more effective treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could reveal why some patients respond to treatment and others do not, pointing toward more personalized therapies for autoimmune liver diseases.
What could go wrong
This is an observational study, not a treatment trial. It will not directly test any new drug or cure, and results may take years to translate into clinical practice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 800 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

May 2038

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients from 10 years old to patients without limit age, male or female, with Auto-Immune Hepatitis or Metabolic steatohepatitis or Drug induced Hepatitis

Ages

10 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

autoimmune hepatitis drug-induced hepatitis metabolic dysfunction-associated steatohepatitis primary biliary cholangitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autoimmune liver diseases Immunological mechanisms

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    13 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AP-HP Beaujon

    Clichy, France

  • AP-HP Paul Brousse

    Villejuif, France

  • AP-HP Saint-Antoine

    Paris, France

  • CHD Vendée

    La Roche-sur-Yon, France

  • CHU Nantes

    Nantes, France

  • CHU Poitiers

    Poitiers, France

  • CHU d'Angers

    Angers, France

  • CHU de Brest

    Brest, France

  • CHU de Lille

    Lille, France

  • CHU de Rennes

    Rennes, France

  • CHU de Toulouse

    Toulouse, France

  • CHU de Tours

    Tours, France

  • Hospices Civils de Lyon

    Lyon, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.