Is Negativity of Autoantibodies a Marker of Severity in Auto-immune Hepatitis?
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: blood sampling.
- Who it may be relevant to
- Registry conditions: Auto-immune Hepatitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Is Negativity of Autoantibodies a Marker of Severity in Auto-immune Hepatitis
Overview
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
- 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.
Primary outcome measures
- histological rereading of seronegative AIH [Time frame: Baseline]
Secondary outcome measures (2)
- assessment of the severity of the disease [Time frame: 6 months, 12 months]
- Constitution of a serotheque in order to search for other autoAb described as correlated to the severity of the AIH. [Time frame: At inclusion]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 2 centers
- Hospital of Saint-Antoine — Paris
- CHU de Pointe-à Pitre — Pointe à Pitre
Identifiers
NCT: NCT06761209 · PAP_RIPH2_2020/21 · 2020-A02908-31