Actively Recruiting
Is Negativity of Autoantibodies a Marker of Severity in Auto-immune Hepatitis
Led by Centre Hospitalier Universitaire de la Guadeloupe · Updated on 2025-01-07
100
Participants Needed
2
Research Sites
230 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the presence of seronegative auto-immune hepatitis and its possible link to disease severity. Severity is defined by dependence on corticosteroids, resistance to corticosteroids, and severe disease forms at diagnosis such as cirrhosis or fulminant hepatitis. If seronegative cases are common, the study will also search for other auto-antibodies related to this autoimmune hepatitis. The study involves patients from the Guadeloupean constitutive center of rare diseases (CCRD Filfoie) and Saint-Antoine hospital. Both retrospective analysis of existing patients and prospective follow-up of new patients will be conducted. As part of the study, blood samples will be collected to build a serological library to identify rare auto-antibodies that may serve as prognostic markers. Participants will have their medical history reviewed and undergo blood sampling to collect serological data. Researchers will analyze tissue samples through histological rereading of seronegative autoimmune hepatitis at baseline. The study will monitor disease severity based on clinical criteria and antibody presence. Patients will be followed over time to better understand the relationship between seronegativity and disease outcomes.
CONDITIONS
Official Title
Is Negativity of Autoantibodies a Marker of Severity in Auto-immune Hepatitis?
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Patient followed at Hôpital Saint-Antoine or treated for autoimmune hepatitis (acute or chronic) at CCRD Filfoie in Guadeloupe
- Under immunosuppressive treatment for autoimmune hepatitis
- Affiliated or beneficiary of a social security scheme
- Signed free, informed, and written consent by patient and investigator
You will not qualify if you...
- Under 18 years old
- Unable to give consent
- Viral hepatitis types A to E, Epstein-Barr virus, cytomegalovirus, or herpes simplex virus infection
- Isolated primary biliary cholangitis
- Isolated primary sclerosing cholangitis
- Drug-induced liver injury
- Wilson disease
- Alcoholic hepatitis
- Hemochromatosis
- Sickle cell disease with heart liver involvement
- Non-alcoholic steato-hepatitis
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Hospital of Saint-Antoine
Paris, France, France, 75012
Not Yet Recruiting
2
CHU de Pointe-à Pitre
Pointe à Pitre, Guadeloupe, France, 97159
Actively Recruiting
Research Team
V
Valérie SOTER, Promotion Unit manager
E
Eunice NUBRET, Project manager
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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