PROlonged Corticosteroid Treatment or N-ACetylcysteine for Severe Alcoholic Hepatitis

Launched by UNIVERSITY HOSPITAL, LILLE · Apr 25, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at new treatment options for patients with severe alcoholic hepatitis, a serious liver condition caused by heavy drinking. The study will compare two treatment strategies: one involves continuing the standard treatment of oral prednisolone for 28 days, while the other explores whether adding N-acetylcysteine, an antioxidant, can improve patient outcomes. Researchers want to see if these strategies can reduce both the risk of death and liver damage after 90 days, which is a new approach compared to previous studies that focused mainly on survival.

To participate in this trial, patients need to be between 18 and 75 years old, have been drinking heavily for some time, and have recently developed jaundice (yellowing of the skin and eyes). They must also have confirmed severe alcoholic hepatitis and meet certain health criteria. If eligible, participants will receive close monitoring and may benefit from the latest treatment strategies aimed at improving their liver health and overall survival.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients aged 18-75
• • Alcohol consumption of more than 40g/day (women) and 50g/day (men)
• • Recent onset of jaundice (\<3 months)
• • Biopsy proven alcoholic hepatitis (transjugular liver biopsy)
• • Maddrey's discriminant function ≥ 32, defining severe alcoholic hepatitis
• • MELD score ≥ 17
• • Patients covered with social insurance
• • Patients having provided written informed consent to participate
• Exclusion Criteria:
• • Hepatocellular carcinoma
• • Uncontrolled gastrointestinal bleeding
• • Previous severe allergy or hypersensitivity to N-acetylcysteine (anaphylactic shock, Quincke edema, severe urticaria)
• • Hypersensitivity to any component of the medication
• • MELD score \<17
• • Type 1 hepatorenal syndrome before the initiation of treatment
• • Severe extrahepatic disease, with life expectancy \< 6 months
• • Any malignant tumor \< 2 years (except skin carcinomas)
• • Ongoing viral or parasitic infection
• • Untreated bacterial infection
• • Tuberculosis \< 5 years
• • Positive blood PCR in patients with positive antibodies against HCV
• • Patient carrying HBV or HIV
• • Treatment with corticosteroids, immunosuppression therapy or budesonide within 6 months before the study