N-Acetylcysteine in Severe Acute Alcoholic Hepatitis

Alcoholic Hepatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00962442
• Other study ID #: AAH-LYSO
• Status: Completed
• Phase: Phase 3
• First received: August 19, 2009
• Last updated: August 19, 2009
• Start date: September 2000

Study information

• Verified date: August 2009
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcoholic Hepatitis
• Hepatitis
• Hepatitis A
• Hepatitis, Alcoholic

Intervention

Drug:
• N-Acetylcysteine
300 mg/kg for 14 days, intravenously
• placebo
Glucosé 5% perfusion for 14 days, intravenously

Locations

Country	Name	City	State
Belgium	Erasme University Hospital	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Six months survival			No
Secondary	Rate of infections, clinical and biological parameters			Yes