N-ACetylcysteine to Reduce Infection and Mortality for Alcoholic Hepatitis

Last updated: November 8, 2021
Sponsor: Imperial College London
Overall Status: Active - Recruiting

Phase

3

Condition

Liver Disorders

Hepatitis

Treatment

N/A

Clinical Study ID

NCT03069300
14SM2383
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

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 Design

Total Participants: 42
Study Start date:
October 01, 2015
Estimated Completion Date:
June 01, 2025

Study Description

Randomised controlled trial, open label.

Connect with a study center

  • St Mary's Hospital, Imperial College

    London, W2 1NY
    United Kingdom

    Active - Recruiting

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