ClinicalTrials.gg
CompletedNCT07784881DISTALUpdated Sep 1, 2026

Deciphering the Self-antigen Specific T Cell Signature of Autoimmune Liver Diseases

An observational study in Autoimmune Hepatitis, Primary Biliary Cholangitis (PBC) and Autoimmune Liver Disease, sponsored by Nantes University Hospital. Completed at 1 site in France. Per ClinicalTrials.gov, last updated 2026-09-01.

Sponsored by Nantes University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
220
Sex
All
01

Study summary

The study aims to establish the molecular signature of autoimmune self-antigen-specific T cells in AutoImmune Liver Disease (AILD)

02

Conditions studied

  • Autoimmune Hepatitis
  • Primary Biliary Cholangitis (PBC)
  • Autoimmune Liver Disease
  • Primary Sclerosing Cholangitis (PSC)
03

In context

Hepatitis, Autoimmune

82 studies on the registry are indexed under Hepatitis, Autoimmune; 24 are open to participants now.

This study's enrollment of 220 is below the median of 273 across 36 observational studies indexed under Hepatitis, Autoimmune.

Browse Hepatitis, Autoimmune studies →

Lead sponsor

Nantes University Hospital is the lead sponsor of 839 studies on the registry; 195 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with Auto-Immune Hepatitis

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient
  • AIH with no previous treatment whose diagnosis is validated by at least 2 of the following criteria:
  • >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

Exclusion criteria

Exclusion Criteria:

  • positive
  • infection Positive
  • serology positive and PCR positive
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
220 participants (actual)
Patient registry
No

Groups and cohorts

  • AILD Patients

    Patients with Auto-Immune Hepatitis

06

What researchers measure

Primary outcomes

  1. Establish the molecular signature of autoimmune self-antigen-specific T cells in AILD

    Time frame: 4 years

07

Study locations

1 site
  • Nantes University Hospital
    Nantes, 44093, France
08

References and documents

Publications

  • Cardon A, Guinebretiere T, Dong C, Gil L, Ado S, Gavlovsky PJ, Braud M, Danger R, Schultheiss C, Domene A, Paul-Gilloteaux P, Chevalier C, Bernier L, Judor JP, Fourgeux C, Imbert A, Khaldi M, Bardou-Jacquet E, Elkrief L, Lannes A, Silvain C, Schnee M, Tanne F, Vavasseur F, Brusselle L, Brouard S, Kwok WW, Mosnier JF, Lohse AW, Poschmann J, Binder M, Gournay J, Conchon S, Milpied P, Renand A. Single cell profiling of circulating autoreactive CD4 T cells from patients with autoimmune liver diseases suggests tissue imprinting. Nat Commun. 2025 Jan 29;16(1):1161. doi: 10.1038/s41467-025-56363-2. PubMed 39880819 ↗
  • Imbert A, Gavlovsky PJ, Judor JP, Bardou-Jacquet E, Elkrief L, Lannes A, Silvain C, Schnee M, Tanne F, Chevalier C, Vavasseur F, Khaldi M, Brouard S, Mosnier JF, Gournay J, Conchon S, Renand A. T cell immuno-phenotyping : a source of predictive biomarkers for autoimmune hepatitis relapse. Sci Rep. 2024 Oct 18;14(1):24448. doi: 10.1038/s41598-024-75624-6. PubMed 39424872 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07784881
Responsible party
Sponsor
First posted
Aug 25, 2026
Start date
Apr 20, 2021
Primary completion
Oct 24, 2025
Completion
Oct 24, 2025
Last update
Sep 1, 2026

Study contacts

Jérôme Gournay
principal investigator · Nantes University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion