N-Acetylcysteine in Severe Acute Alcoholic Hepatitis
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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 |
- Six months survival [ Designated as safety issue: No ]
- 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 |
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 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 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 May 22, 2013