N-Acetylcysteine in Severe Acute Alcoholic Hepatitis

This study has been completed.
Sponsor:
Information provided by:
Erasme University Hospital
ClinicalTrials.gov Identifier:
NCT00962442
First received: August 19, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of infections, clinical and biological parameters [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00962442

Locations
Belgium
Erasme University Hospital
Brussels, Belgium, 1070
Sponsors and Collaborators
Erasme University Hospital
  More Information

No publications provided

Responsible Party: Olivier Le Moine, MD, PhD, Erasme University Hospital
ClinicalTrials.gov Identifier: NCT00962442     History of Changes
Other Study ID Numbers: AAH-LYSO
Study First Received: August 19, 2009
Last Updated: August 19, 2009
Health Authority: Belgium: Institutional Review Board

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
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes

ClinicalTrials.gov processed this record on August 18, 2014