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PROlonged Corticosteroid Treatment or N-ACetylcysteine for Severe Alcoholic Hepatitis

RecruitingPhase 3Ages 18 Years - 75 YearsAllUniversity Hospital, Lille
NCT06956482 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Only patients suffering from a severe form of alcoholic hepatitis (Maddrey's discriminant function greater than 32) require medical treatment. Oral prednisolone for 28 days is the only treatment which has been proven to improve short-term survival over placebo in patients with severe alcoholic hepatitis. However, prednisolone alone cannot be regarded as an ideal treatment because some patients still have a bad outcome despite being treated with corticosteroids. Response to treatment can be predicted by the Lille score, a simple tool that is calculated after 7 days of prednisolone course. The ideal binary cut-off of the Lille is 0.45, responders having a Lille score \< 0.45 and non-responders having a Lille score ≥0.45. In terms of treatment management, approximately 30% of patients with severe alcoholic hepatitis do not take benefit from prednisolone and are classified as null responders

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📋 Eligibility rules (as published)
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
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What it tests

  • N-Acetylcysteine (NAC) Treatment
  • Prednisolone
  • Placebo of N-acetylcysteine
  • Placebo of Prednisolone 10mg
  • Prednisolone 10mg
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Where

1 site
CHU de Lille, Hôpital Huriez
Lille, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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