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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
Sponsor:
Information provided by:
Erasme University Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alcoholic Hepatitis Drug: N-Acetylcysteine Drug: placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: N-Acetylcysteine for the Treatment of Alcoholic Hepatitis: a Belgian Multicenter Randomised Trial
Study Start Date : September 2000
Actual Primary Completion Date : January 2006

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Arms and Interventions
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Arm Intervention/treatment
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
 Drug: N-Acetylcysteine
300 mg/kg for 14 days, intravenously
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
 Drug: placebo
Glucosé 5% perfusion for 14 days, intravenously


Outcome Measures
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Primary Outcome Measures :
  1. Six months survival

Secondary Outcome Measures :
  1. Rate of infections, clinical and biological parameters

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00962442


Locations
Belgium
Erasme University Hospital
Brussels, Belgium, 1070
Sponsors and Collaborators
Erasme University Hospital
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Olivier Le Moine, MD, PhD, Erasme University Hospital
ClinicalTrials.gov Identifier: NCT00962442     History of Changes
Other Study ID Numbers: AAH-LYSO
First Posted: August 20, 2009    Key Record Dates
Last Update Posted: August 20, 2009
Last Verified: August 2009

Keywords provided by Erasme University Hospital:
alcoholic hepatitis
N-Acetylcysteine
enteral nutrition
oxidative stress
severe acute alcoholic hepatitis

Additional relevant MeSH terms:
Hepatitis, Alcoholic
Hepatitis
Hepatitis A
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
 Chemically-Induced Disorders
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes