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N-ACetylcysteine to Reduce Infection and Mortality for Alcoholic Hepatitis

N-ACetylcysteine to Reduce Infection and Mortality for Alcoholic Hepatitis

Non Recruiting
18 years and older
All
Phase 3

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Overview

Recent data have suggested that monocyte oxidative burst defect is associated with the development of infection in patients with severe alcoholic hepatitis. One report found reduced 28 day mortality in patients treated with N-acetylcysteine combined with prednisolone when compared to prednisolone alone. The current study seeks to reveal whether the mechanism by which NAC reduces susceptibility to infection is through improvement of phagocyte oxidative burst.

Description

Randomised controlled trial, open label.

Eligibility

Inclusion Criteria:

  • Aged 18 years or older
  • Clinical alcoholic hepatitis:
    • Serum bilirubin >80umol/L
    • History of alcohol excess (>80g/day male, >60g/day female)
    • Less than 4 weeks since admission to hospital
    • Maddrey's discriminant function (DF) >32
    • Informed consent

Exclusion Criteria:

  • Alcohol abstinence of >6 weeks prior to randomisation
  • Duration of jaundice >3 months
  • Other causes of liver disease including:
    • Evidence of viral hepatitis (hepatitis B or C)
    • Biliary obstruction
    • Hepatocellular carcinoma
  • Evidence of current malignancy (except non-melanotic skin cancer)
  • Previous entry into the study
  • Patients with known hypersensitivity or previous reactions to NAC
  • Pregnant or lactating women

Study details
    Alcoholic Hepatitis
    Infection

NCT03069300

Imperial College London

20 August 2025

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