Is Negativity of Autoantibodies a Marker of Severity in Auto-immune Hepatitis? (HAI-NEG)

Centre Hospitalier Universitaire de la Guadeloupe

Status: Enrolling

Conditions: Auto-immune Hepatitis

Treatments: Other: blood sampling

Study type: Observational

Funder types: Other

Identifiers

NCT06761209

2020-A02908-31 (Other Identifier)

PAP_RIPH2_2020/21

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

100 participants in 1 patient group

acute or chronic Auto-Immune Hepatitis patients

Description:

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

Treatment:

Other: blood sampling