NCT06761209

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
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Centre Hospitalier Universitaire de la Guadeloupe · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Auto-immune Hepatitis

Interventions

Type	Name	Description
OTHER	blood 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.

Timeline

• Start date: 2022-07-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-01-07
• Last updated: 2025-01-07

Locations

2 sites across 1 country: France