Actively Recruiting
Studying the Link Between Negative Autoantibodies and Disease Severity in Auto-immune Hepatitis Including Patients With Acute or Chronic Auto-immune Hepatitis Under Immunosuppressive Treatment
Led by Centre Hospitalier Universitaire de la Guadeloupe · Updated on 2025-01-07
100
Participants Needed
2
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying auto-immune hepatitis, focusing on patients who do not show typical autoantibodies seronegative. The study aims to understand how common this seronegative form is and whether it relates to how severe the disease is. Severity will be assessed by treatment resistance or dependence on steroids and by severe disease signs like cirrhosis or sudden liver failure. If seronegative cases are common, the study will look for other rare autoantibodies linked to the disease. Participants include those with acute or chronic auto-immune hepatitis from specific hospitals or disease centers in Guadeloupe and Saint-Antoine. Blood samples will be collected to create a serological library, helping researchers find rare autoantibodies that may serve as markers for disease prognosis. This observational study involves analyzing past patient data and following new patients over time. Participants will provide blood samples at inclusion and be monitored to assess disease severity at six and twelve months. The main outcome is a histological review of seronegative cases at the start. Secondary outcomes include severity evaluations and building a serotheque to identify other autoantibodies. The study ensures informed consent and follows patients receiving immunosuppressive treatment under usual care settings.
CONDITIONS
Brief Title
Is Negativity of Autoantibodies a Marker of Severity in Auto-immune Hepatitis?
Research Team
V
Valérie SOTER, Promotion Unit manager
E
Eunice NUBRET, Project manager
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