Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2025-12-24 @ 7:10 PM
NCT ID:
NCT05473403
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years
* Strong clinical suspicion of severe acute autoimmune hepatitis defined by the presence of increased IgG and/or autoantibodies and/or histology characteristic of the disease in the absence of other causes of severe acute hepatitis.
* International Normalized Ratio (INR) ≥ 1.5
* Informed, written consent
* Patient having the rights to French social insurance
Exclusion Criteria:
* Previous medical history of chronic liver disease including autoimmune liver disease (AIH, Primary Biliary Cholangitis (PBC), Primary Sclerosing Cholangitis (PSC) , alcoholic hepatitis etc.)
* Other causes of acute severe hepatitis:
* Hepatitis A Virus (HAV) hepatitis, defined by HAV Immunoglobulin M (IgM) antibodies
* Hepatitis B Virus (HBV) hepatitis, defined by HBs antigen and HBV IgM antibodies
* Hepatitis E Virus (HEV) hepatitis, defined by HEV IgM antibodies or positive HEV-RNA in immunosuppressed patients
* Drug induced hepatitis, histologically proved or induced by well-known hepatotoxic substances
* Acute hypoxemic hepatitis, context of shock, hypoxemia or heat shock
* Budd-Chiari syndrome, diagnosed by imagery (Doppler ultrasound, CT scan)
* Acute hepatitis in the context of a HELLP (Hemolysis, Elevated Liver enzymes and a Low Platelet count) syndrome or acute fatty liver of pregnancy
* Use of corticosteroids 1 month before inclusion
* Pregnant or lactating woman
* Curator or guardianship or patient placed under judicial protection
* Participation in other interventional research during the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT05473403
Study Brief:
Protocol Section:
NCT05473403