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Clinical Trials in France / NCT06761209
Recruiting Observational

Is Negativity of Autoantibodies a Marker of Severity in Auto-immune Hepatitis?

NCT06761209 · tracked via the Priya Life Science France tracker
Sponsor
Centre Hospitalier Universitaire de la Guadeloupe
Phase
Observational
Started
2022-07-01
Last updated
2025-01-07

Condition(s) studied

Auto-immune Hepatitis

Investigational drug(s) / intervention(s)

blood sampling

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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Hospital of Saint-Antoine Paris France Not Yet Recruiting
CHU de Pointe-à Pitre Pointe à Pitre Guadeloupe Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06761209 on ClinicalTrials.gov ↗ ← All trials in France