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Is Negativity of Autoantibodies a Marker of Severity in Auto-immune Hepatitis?

Is Negativity of Autoantibodies a Marker of Severity in Auto-immune Hepatitis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06761209
Acronym
HAI-NEG
Enrollment
100
Registered
2025-01-07
Start date
2022-07-01
Completion date
2026-12-31
Last updated
2025-01-07

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

Conditions

Auto-immune Hepatitis

Keywords

autoantibodies, auto-immune hepatitis, prognosis, afrocaribbean population

Brief summary

Evaluate the proportion of seronegative auto-immune hepatitis and a possible relationship with the severity of the disease. Criteria of severity will be defined by corticodependance, corticoresistance and a severe form of the disease at diagnosis (cirrhosis or fulminant hepatitis). In case of predominant seronegative forms, other auto-antibodies related to this auto-immue hepatitis will be searched.

Detailed description

Evaluate the proportion of seronegative auto-immune hepatitis and a possible relationship with the severity of the disease. Criteria of severity will be defined by corticodependance, corticoresistance and a severe form of the disease at diagnosis (cirrhosis or fulminant hepatitis). In case of predominant seronegative forms, other auto-antibodies related to this auto-immue hepatitis will be searched. Patients from the Guadeloupean constitutive center of rare diseases (CCRD Filfoie) and from the Saint-Antoine hospital will be retrospectively analyzed, and new patients will be prospectively followed.

Interventions

OTHERblood sampling

For the study, a blood sample will be collected from the patient in order to do build up a serological library which will allow the search for rare autoAb whose interest has been demonstrated as prognostic factors of the disease.

Sponsors

Centre Hospitalier Universitaire de la Guadeloupe
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* \- Any patient over 18 years old * Patient followed at Hôpital Saint-Antoine or treated for HAI or in Guadeloupe within the framework of the CCRD Filfoie for an acute or chronic AIH under immunosuppressive treatment * Patient affiliate or beneficiary of a social security scheme * Free, informed and written consent signed by the patient and the investigator o

Exclusion criteria

- Patient under 18 years old * Patient not able to give his/her consent * Viral hepatitis: viruses A to E, Epstein-Barr virus, cytomegalovirus and herpes simplex virus * Isolated primary biliary cholangitis * Isolated primary sclerosing cholangitis * Drug-induced liver injury * Wilson disease * Alcoholic hepatitis * Hemochromatosis * Sickle cell disease and heart liver * Non-alcoholic steato-hepatitis

Design outcomes

Primary

MeasureTime frameDescription
histological rereading of seronegative AIHBaselinePercentage comparisons will be made by a chi-2 test or a Fischer test.

Secondary

MeasureTime frameDescription
assessment of the severity of the disease6 months, 12 months\- Number of corticosteroid HAI defined by the maintenance of corticosteroid therapy\> 20mg / d beyond 6 months of treatment - Number of corticosteroid-resistant AIH. Percentage comparisons will be made by a chi-2 test or a Fischer test.
Constitution of a serotheque in order to search for other autoAb described as correlated to the severity of the AIH.At inclusionConstitution of a serotheque in order to search for other autoAb described as correlated to the severity of the AIH.

Countries

France

Contacts

Primary ContactValérie SOTER, Promotion Unit manager
valerie.soter@chu-guadeloupe.fr+590 590 934677
Backup ContactEunice NUBRET, Project manager
eunice.nubret@chu-guadeloupe.fr+590 0590934686

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026