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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07784881

Acronym

DISTAL

Enrollment

220

Registered

2026-08-25

Start date

2021-04-20

Completion date

2025-10-24

Last updated

2026-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Establish the molecular signature of autoimmune self-antigen-specific T cells in AILD	4 years

Countries

France

Contacts

PRINCIPAL_INVESTIGATORJérôme Gournay

Nantes University Hospital

Outcome results