Suspended

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

What is being tested

N-acetyl cysteine (NAC)

Drug

Who is being recruted

Digestive System Diseases+7

+ Hepatitis

+ Hepatitis, Alcoholic

Over 18 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: October 2015

See protocol details

Summary

Principal SponsorImperial College London

Study ContactNikhil Vergis, PhDMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2015

Actual date on which the first participant was enrolled.

Randomised controlled trial, open label.

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

NCT03069300

Principal SponsorImperial College London

Study ContactNikhil Vergis, PhDMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

42 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesHepatitisHepatitis, AlcoholicInfectionsLiver DiseasesLiver Diseases, AlcoholicSubstance-Related DisordersAlcohol-Related DisordersAlcohol-Induced DisordersChemically-Induced Disorders

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

40mg prednisolone once a day for 28 days and 30 minutes of intravenous NAC at 150mg/kg in 250ml 5% dextrose solution followed by 4 hours of intravenous NAC at 50mg/kg in 500ml 5% dextrose solution, followed by 16 hours of intravenous NAC at 100 mg/kg in 1000ml 5% dextrose solution, followed by 4 days of intravenous NAC at 100mg/kg/day in 1000ml 5% dextrose solution

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

St Mary's Hospital, Imperial College

London, United KingdomOpen St Mary's Hospital, Imperial College in Google Maps

SuspendedOne Study Center