Validation of a Prognostic Score for Steroid Therapy Response in Acute Severe Autoimmune Hepatitis

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Jul 22, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new way to predict which patients with acute severe autoimmune hepatitis (AIH) will respond well to high doses of corticosteroids, a type of medication, and which patients might need a liver transplant instead. Autoimmune hepatitis is a serious liver disease where the body’s immune system mistakenly attacks the liver. Doctors currently have guidelines on how to treat this condition, but they need a better method to determine if patients are improving after starting treatment.

To be eligible for this trial, participants must be at least 18 years old and show strong signs of severe acute autoimmune hepatitis, such as high levels of certain antibodies in their blood. They also need to have a specific blood test result indicating liver dysfunction. Participants will be monitored closely after starting corticosteroid treatment, with evaluations happening around day three to see if they are responding to the medication. The trial aims to help doctors make quicker and more accurate decisions about treatment options for patients facing this serious condition.

Gender

ALL

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