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Completed

NCT Number: NCT00962442

N-Acetylcysteine in Severe Acute Alcoholic Hepatitis

Acute alcoholic hepatitis (AAH) is the most severe form of alcoholic liver disease (ALD) and is associated with a high risk of dying in the short term. Corticosteroids are generally recommended in patients with severe AAH, but its use is still controverted and contraindicated in case of active infection or gastrointestinal bleeding. Therefore, alternative therapeutic options are needed.Ethanol consumption results in the depletion of endogenous antioxidant capabilities and patients with ALD have evidence of antioxidant deficiencies.Due to its effects on glutathion stores restoration and as such the limitation of the oxidative stress and its good tolerance and safety profile, N-acetylcysteine (NAC) is an attractive agent for the treatment of AAH.In this context, we hypothesized that NAC might be beneficial in severe AAH.

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Key information

Conditions

Alcoholic Hepatitis Alcohol-Induced Disorders Alcohol-Related Disorders Chemically-Induced Disorders Digestive System Diseases Hepatitis Hepatitis, Alcoholic Liver Diseases Liver Diseases, Alcoholic Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Erasme University Hospital

Brussels, 1070, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Biopsy proven alcoholic hepatitis
  • Severe disease defined by a Maddrey score superior to 32

Exclusion criteria

  • Neoplastic disease compromising 6 months survival
  • HIV patients
  • Hepatorenal syndrome

Treatment and study plan

N-acetylcysteine

Drug

300 mg/kg for 14 days, intravenously

Placebo

Drug

Glucosé 5% perfusion for 14 days, intravenously

Primary outcomes

  1. Six months survival

Secondary outcomes

  1. Rate of infections, clinical and biological parameters

Sponsors and collaborators

Lead sponsor

Erasme University Hospital

Other

Registry information

Official study title

N-Acetylcysteine for the Treatment of Alcoholic Hepatitis: a Belgian Multicenter Randomised Trial

Important dates

Study start
2000
Primary completion
2006
First posted
Aug 20, 2009
Registry last updated
Aug 20, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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