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

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
|
- Six months survival
- Rate of infections, clinical and biological parameters

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
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

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
Belgium | |
Erasme University Hospital | |
Brussels, Belgium, 1070 |
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 |