Is Negativity of Autoantibodies a Marke… | Clinical Trial

Key information

Conditions

Auto-immune Hepatitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital of Saint-Antoine, Paris, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Blood sampling

Other

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.

Primary outcomes

histological rereading of seronegative AIH

Time frame: Baseline

Percentage comparisons will be made by a chi-2 test or a Fischer test.

Secondary outcomes

assessment of the severity of the disease

Time frame: 6 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.

Time frame: At inclusion

Constitution of a serotheque in order to search for other autoAb described as correlated to the severity of the AIH.

Study contacts

Contact information is provided by the study sponsor or research team.

Eunice NUBRET, Project manager

CONTACT

[email protected]

+590 0590934686

Valérie SOTER, Promotion Unit manager

CONTACT

[email protected]

+590 590 934677

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de la Guadeloupe

Other

Registry information

Official study title

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

Acronym: HAI-NEG

Important dates

Study start: 2022
Primary completion: 2026
Study completion: 2026
First posted: Jan 7, 2025
Registry last updated: Jan 7, 2025

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.