Autoimmune HepatitisDISTALNCT07784881
Deciphering the Self-antigen Specific T Cell Signature of Autoimmune Liver Diseases
An observational study of Autoimmune Hepatitis and Primary Biliary Cholangitis (PBC), run by Nantes University Hospital at 1 site in France.
Trial summary
The study aims to establish the molecular signature of autoimmune self-antigen-specific T cells in AutoImmune Liver Disease (AILD) Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Autoimmune Hepatitis, Primary Biliary Cholangitis (PBC), Autoimmune Liver Disease
- How many people
- 220 participants
- Where
- 1 siteFrance
- Study dates
- 20 Apr 2021to 24 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with Auto-Immune Hepatitis
Who may be able to join
- 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
Who cannot join
- HIV positive
- HBV infection Positive
- HCV serology positive and PCR positive
Trial locations and contacts
1 site in 1 country.
About this study
The study aims to establish the molecular signature of autoimmune self-antigen-specific T cells in AutoImmune Liver Disease (AILD)
- Conditions
- Autoimmune Hepatitis, Primary Biliary Cholangitis (PBC), Autoimmune Liver Disease, Primary Sclerosing Cholangitis (PSC)
- Medical subject headings
- Hepatitis, Autoimmune, Liver Cirrhosis, Biliary, Cholangitis, Sclerosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AILD Patients | Patients with Auto-Immune Hepatitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish the molecular signature of autoimmune self-antigen-specific T cells in AILD
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start20 Apr 2021
- Primary completion24 Oct 2025
- Study completion24 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autoimmune HepatitisStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jérôme Gournay, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07784881
- Sponsor's protocol ID
- RC19_0359
- Other IDs
- ANR-19-CE17-0024-01
- Acronym
- DISTAL
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 39880819Imbert 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 at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deciphering the Self-antigen Specific T Cell Signature of Autoimmune Liver Diseases
- ClinicalTrials.gov ID
- NCT07784881
- Acronym / sponsor ID
- DISTAL / RC19_0359
- Conditions
- Autoimmune Hepatitis, Primary Biliary Cholangitis (PBC), Autoimmune Liver Disease, Primary Sclerosing Cholangitis (PSC)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 24 Oct 2025 (actual)
- Study completion
- 24 Oct 2025 (actual)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to establish the molecular signature of autoimmune self-antigen-specific T cells in AutoImmune Liver Disease (AILD)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AILD Patients | – | –Patients with Auto-Immune Hepatitis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Auto-Immune Hepatitis
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- HIV positive
- HBV infection Positive
- HCV serology positive and PCR positive
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Establish the molecular signature of autoimmune self-antigen-specific T cells in AILD
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Results publication: PubMed 39880819Cardon 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.
- Results publication: PubMed 39424872Imbert 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jérôme Gournay principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Hepatitis and Primary Biliary Cholangitis (PBC), run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish the molecular signature of autoimmune self-antigen-specific T cells in AILD (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07784881, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.