Evaluating the role of autoantibodies in autoimmune hepatitis severity
Official title: Is Negativity of Autoantibodies a Marker of Severity in Auto-immune Hepatitis
Run by Centre Hospitalier Universitaire de la Guadeloupe · NCT06761209 · Data updated 2026-11-12
This study is trying to see if certain autoantibodies in the blood can help us understand how severe autoimmune hepatitis is in patients.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Centre Hospitalier Universitaire de la Guadeloupe Academic / other |
| Locations | 2 sites (Paris, France and 1 other locations) |
| Status | Recruiting |
| Started | July 1, 2022 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | January 7, 2025 |
| Trial ID | NCT06761209 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults over 18 years old diagnosed with autoimmune hepatitis and receiving immunosuppressive treatment.
✕Probably not a fit
Patients with other liver diseases such as viral hepatitis, primary biliary cholangitis, or drug-induced liver injury will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the prevalence of seronegative autoantibodies in patients with autoimmune hepatitis and explore their potential correlation with disease severity. Severity will be determined based on criteria such as dependence on corticosteroids, resistance to corticosteroids, and the presence of severe forms of the disease at diagnosis, including cirrhosis or fulminant hepatitis. The study will involve retrospective analysis of patients from the Guadeloupean center for rare diseases and prospective follow-up of new patients. Blood samples will be collected to analyze autoantibodies related to autoimmune hepatitis.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of autoimmune hepatitis severity and improve patient management strategies.
How similar studies have gone: While the specific approach of evaluating seronegative autoantibodies in this context may be novel, similar studies have shown promise in understanding autoimmune diseases.
Who can join: the full rules
Show full inclusion / 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
Where it's running
-
CHU de Pointe-à Pitre
Pointe à Pitre, Guadeloupe, France Recruiting -
Hospital of Saint-Antoine
Paris, France, France Not yet recruiting
Study contacts
- Principal investigator: Moana Lemoinne, doctor — chu de pointe à pitre
- Study coordinator: Valérie SOTER, Promotion Unit manager
- Email: valerie.soter@chu-guadeloupe.fr
- Phone: +590 590 934677
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.