NCT00962442

N-Acetylcysteine in Severe Acute Alcoholic Hepatitis

N-Acetylcysteine for the Treatment of Alcoholic Hepatitis: a Belgian Multicenter Randomised Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Erasme University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alcoholic Hepatitis

Interventions

Type	Name	Description
DRUG	N-Acetylcysteine	300 mg/kg for 14 days, intravenously
DRUG	placebo	Glucosé 5% perfusion for 14 days, intravenously

Timeline

• Start date: 2000-09-01
• Primary completion: 2006-01-01
• First posted: 2009-08-20
• Last updated: 2009-08-20

Locations

1 site across 1 country: Belgium