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N-Acetylcysteine in Severe Acute Alcoholic Hepatitis

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ClinicalTrials.gov Identifier: NCT00962442
Recruitment Status : Completed
First Posted : August 20, 2009
Last Update Posted : August 20, 2009
Information provided by:
Erasme University Hospital

August 19, 2009
August 20, 2009
August 20, 2009
September 2000
January 2006   (Final data collection date for primary outcome measure)
Six months survival
Same as current
No Changes Posted
Rate of infections, clinical and biological parameters
Same as current
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Not Provided
N-Acetylcysteine in Severe Acute Alcoholic Hepatitis
N-Acetylcysteine for the Treatment of Alcoholic Hepatitis: a Belgian Multicenter Randomised Trial
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.
Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Alcoholic Hepatitis
  • Drug: N-Acetylcysteine
    300 mg/kg for 14 days, intravenously
  • Drug: placebo
    Glucosé 5% perfusion for 14 days, intravenously
  • Active Comparator: nutritional support + N-Acétylcysteine
    N-Acétylcysteine 300 mg/kg intravenously for 14 days Beside usual meals, patients must receive at least 27 kcal/kg/day enteral nutrition for 14 days
    Intervention: Drug: N-Acetylcysteine
  • Placebo Comparator: nutritional support + placebo
    placebo perfusion for 14 days Beside usual meals patients must receive at least 27 kcal/kg/day enteral nutrition for 14 days
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Not Provided
January 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Olivier Le Moine, MD, PhD, Erasme University Hospital
Erasme University Hospital
Not Provided
Not Provided
Erasme University Hospital
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP