N-ACetylcysteine to Reduce Infection and Mortality for Alcoholic Hepatitis (NACAH)

November 8, 2021 updated by: Imperial College London

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Randomised controlled trial, open label.

Study Type

Interventional

Enrollment (Anticipated)

42

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Mark Thursz, MD

Study Locations

  • United Kingdom
      • London, United Kingdom, W2 1NY
        • Recruiting
        • St Mary's Hospital, Imperial College
        • Contact:
          • Nikhil Vergis, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: prednisolone+NAC
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
Drug: N-acetyl cysteine (NAC)
Other Names:
  • NAC
No Intervention: prednisolone
40mg prednisolone for 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement in monocyte oxidative burst
Time Frame: 24 hours
24 hours
Improvement in ex vivo monocyte oxidative burst
Time Frame: 5 days
5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients infected
Time Frame: 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
28 days
Proportion of patients infected
Time Frame: 90 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
90 days
Death
Time Frame: 28 days
28 days
Death
Time Frame: 90 days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Anticipated)

April 1, 2022

Study Completion (Anticipated)

June 1, 2025

Study Registration Dates

First Submitted

February 28, 2017

First Submitted That Met QC Criteria

February 28, 2017

First Posted (Actual)

March 3, 2017

Study Record Updates

Last Update Posted (Actual)

November 9, 2021

Last Update Submitted That Met QC Criteria

November 8, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14SM2383

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

contact investigators

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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