N-ACetylcysteine to Reduce Infection and Mortality for Alcoholic Hepatitis

The Mechanism of Action of N-acetylcysteine for Reducing the Risk of Infection in Alcoholic Hepatitis

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03069300

Acronym

NACAH

Enrollment

Registered

2017-03-03

Start date

2015-10-01

Completion date

2025-06-01

Last updated

2021-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcoholic Hepatitis, Infection

Brief 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.

Detailed description

Randomised controlled trial, open label.

Interventions

DRUGN-acetyl cysteine (NAC)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

randomized controlled trial

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Improvement in monocyte oxidative burst	24 hours
Improvement in ex vivo monocyte oxidative burst	5 days

Secondary

Measure	Time frame	Description
Proportion of patients infected	28 days	Infection will be defined in two ways: i. by new/change in intravenous antibiotic prescription and ii. published clinical and microbiological criteria for infection in the setting of liver disease
Death	28 days	—

Countries

United Kingdom

Contacts

Primary ContactNikhil Vergis, PhD

nvergis@ic.ac.uk

Backup ContactMark Thursz, MD

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026