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N-Acetylcysteine in Severe Acute Alcoholic Hepatitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00962442
First Posted: August 20, 2009
Last Update Posted: August 20, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Erasme University Hospital
  Purpose
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 Intervention Phase
Alcoholic Hepatitis Drug: N-Acetylcysteine Drug: placebo Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Erasme University Hospital:

Primary Outcome Measures:
  • Six months survival

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

Enrollment: 44
Study Start Date: September 2000
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

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

Responsible Party: Olivier Le Moine, MD, PhD, Erasme University Hospital
ClinicalTrials.gov Identifier: NCT00962442     History of Changes
Other Study ID Numbers: AAH-LYSO
First Submitted: August 19, 2009
First Posted: August 20, 2009
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
Hepatitis A
Hepatitis, Alcoholic
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