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N-ACetylcysteine to Reduce Infection and Mortality for Alcoholic Hepatitis | Clinical Trials | Clareo Health

UNKNOWNPHASE3

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

NCT03069300•Imperial College London

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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

Locations (1)

St Mary's Hospital, Imperial College

London, United Kingdom

Key Dates

Start Date

October 1, 2015

Primary Completion Date

April 1, 2022

Completion Date

June 1, 2025

Last Updated

November 9, 2021

Enrollment

ESTIMATED participants

Conditions

Alcoholic HepatitisInfection

Interventions

N-acetyl cysteine (NAC)

DRUG

Contacts

Nikhil Vergis, PhD

CONTACT

nvergis@ic.ac.uk

Mark Thursz, MD

CONTACT

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 9, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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N-ACetylcysteine to Reduce Infection and Mortality for Alcoholic Hepatitis

Inclusion Criteria

Exclusion Criteria

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