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N-ACetylcysteine to Reduce Infection and Mortality for Alcoholic Hepatitis

NCT ID: NCT03069300

Last Updated: 2021-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-01

Study Completion Date

2025-06-01

Brief Summary

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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

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Randomised controlled trial, open label.

Conditions

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Alcoholic Hepatitis Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

N-acetyl cysteine (NAC)

Intervention Type DRUG

prednisolone

40mg prednisolone for 28 days

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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N-acetyl cysteine (NAC)

Intervention Type DRUG

Other Intervention Names

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NAC

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark Thursz, MD

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

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St Mary's Hospital, Imperial College

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Nikhil Vergis, PhD

Role: CONTACT

Email: [email protected]

Mark Thursz, MD

Role: CONTACT

Facility Contacts

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Nikhil Vergis, PhD

Role: primary

References

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Nguyen-Khac E, Thevenot T, Piquet MA, Benferhat S, Goria O, Chatelain D, Tramier B, Dewaele F, Ghrib S, Rudler M, Carbonell N, Tossou H, Bental A, Bernard-Chabert B, Dupas JL; AAH-NAC Study Group. Glucocorticoids plus N-acetylcysteine in severe alcoholic hepatitis. N Engl J Med. 2011 Nov 10;365(19):1781-9. doi: 10.1056/NEJMoa1101214.

Reference Type BACKGROUND
PMID: 22070475 (View on PubMed)

Vergis N, Khamri W, Beale K, Sadiq F, Aletrari MO, Moore C, Atkinson SR, Bernsmeier C, Possamai LA, Petts G, Ryan JM, Abeles RD, James S, Foxton M, Hogan B, Foster GR, O'Brien AJ, Ma Y, Shawcross DL, Wendon JA, Antoniades CG, Thursz MR. Defective monocyte oxidative burst predicts infection in alcoholic hepatitis and is associated with reduced expression of NADPH oxidase. Gut. 2017 Mar;66(3):519-529. doi: 10.1136/gutjnl-2015-310378. Epub 2016 Feb 9.

Reference Type RESULT
PMID: 26860769 (View on PubMed)

Other Identifiers

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14SM2383

Identifier Type: -

Identifier Source: org_study_id