N-ACetylcysteine to Reduce Infection and Mortality for Alcoholic Hepatitis

• Status: Recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Imperial College London
• Treatments: Acetylcysteine; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; N-monoacetylcystine; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

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