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

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

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Key information

Conditions

Autoimmune Hepatitis Autoimmune Diseases Autoimmune Liver Disease Bile Duct Diseases Biliary Tract Diseases Cholangitis Cholangitis, Sclerosing Cholestasis Cholestasis, Intrahepatic Digestive System Diseases Fibrosis Hepatitis Hepatitis, Autoimmune Hepatitis, Chronic Immune System Diseases Liver Cirrhosis Liver Cirrhosis, Biliary Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Primary Biliary Cholangitis (PBC) Primary Sclerosing Cholangitis (PSC)

Sex eligibility

All sexes

Study type

Observational

Primary location

Nantes University Hospital

Nantes, 44093, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Time frame: 4 years

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: DISTAL

Important dates

Study start: 2021
Primary completion: 2025
Study completion: 2025
First posted: Aug 25, 2026
Registry last updated: Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Terminated