N-Acetylcysteine in Severe Acute Alcoholic Hepatitis

Free University of Brussels (ULB)

Status and phase: Completed; Phase 3

Conditions: Alcoholic Hepatitis

Treatments: Drug: placebo; Drug: N-Acetylcysteine

Study type: Interventional

Funder types: Other

Identifiers

NCT00962442

AAH-LYSO

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups, including a placebo group

nutritional support + N-Acétylcysteine

Active Comparator group

Description:

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

Treatment:

Drug: N-Acetylcysteine

nutritional support + placebo

Placebo Comparator group

Description:

placebo perfusion for 14 days Beside usual meals patients must receive at least 27 kcal/kg/day enteral nutrition for 14 days

Treatment:

Drug: placebo