NCT07784881

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
3mo left

Started Aug 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Aug 2026Dec 2026

Study Start

First participant enrolled

August 1, 2026

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

August 20, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 25, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

August 25, 2026

Status Verified

August 1, 2026

Enrollment Period

4 months

First QC Date

August 20, 2026

Last Update Submit

August 20, 2026

Conditions

Autoimmune HepatitisPrimary Biliary Cholangitis (PBC)Autoimmune Liver DiseasePrimary Sclerosing Cholangitis (PSC)

Outcome Measures

Primary Outcomes (2)

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

    8 years

  • Establish the molecular signature of autoimmune self-antigen-specific in AILD

    8 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Auto-Immune Hepatitis

You may qualify if:

  • Patient informed consent
  • AIH with no previous treatment 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

You may not qualify if:

  • HIV positive
  • HBV infection Positive
  • HCV serology positive and PCR positive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nantes University Hospital

Nantes, 44093, France

Location

MeSH Terms

Conditions

Hepatitis, AutoimmuneLiver Cirrhosis, BiliaryCholangitis, Sclerosing

Condition Hierarchy (Ancestors)

Hepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesAutoimmune DiseasesImmune System DiseasesCholestasis, IntrahepaticCholestasisBile Duct DiseasesBiliary Tract DiseasesLiver CirrhosisFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsCholangitis

Study Officials

  • Jérôme Gournay

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jérôme Gournay

CONTACT

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2026

First Posted

August 25, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

August 25, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)