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

Recruiting

• Conditions: Auto-immune Hepatitis

• Registration Number: NCT06761209
• Lead Sponsor: Centre Hospitalier Universitaire de Pointe-a-Pitre

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.

Study Timeline

• Study Start: 2022-07-01
• Status Verified: 2024-12
• Study First Submitted: 2024-12-18
• Study First Submitted QC: 2024-12-30
• Last Update Submitted: 2024-12-30
• Study First Posted: 2025-01-07
• Last Update Posted: 2025-01-07
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
histological rereading of seronegative AIH	Baseline	Percentage comparisons will be made by a chi-2 test or a Fischer test.

Secondary Outcome Measures

Name	Time	Method
assessment of the severity of the disease	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.	At inclusion	Constitution of a serotheque in order to search for other autoAb described as correlated to the severity of the AIH.

Trial Locations

Locations (2)

CHU de Pointe-à Pitre; 🇫🇷 Pointe-à-Pitre, Guadeloupe, France

Hospital of Saint-Antoine; 🇫🇷 Paris, France