N-Acetylcysteine in Severe Acute Alcoholic Hepatitis

NCT00962442 | Completed Phase 3 DMC

• 1 other identifier: AAH-LYSO
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

alcoholic hepatitis; N-Acetylcysteine; enteral nutrition; oxidative stress; severe acute alcoholic hepatitis

Outcome Measures

Primary Outcomes (1)

• Six months survival

Secondary Outcomes (1)

• Rate of infections, clinical and biological parameters

Study Arms (2)

nutritional support + N-Acétylcysteine

ACTIVE COMPARATOR

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

nutritional support + placebo

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

N-Acetylcysteine DRUG

300 mg/kg for 14 days, intravenously

nutritional support + N-Acétylcysteine

placebo DRUG

Glucosé 5% perfusion for 14 days, intravenously

nutritional support + placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biopsy proven alcoholic hepatitis
• Severe disease defined by a Maddrey score superior to 32

You may not qualify if:

• Neoplastic disease compromising 6 months survival
• HIV patients
• Hepatorenal syndrome

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (1)

Erasme University Hospital

Brussels, 1070, Belgium

Location

MeSH Terms

Conditions

Hepatitis, Alcoholic

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Hepatitis; Liver Diseases; Digestive System Diseases; Liver Diseases, Alcoholic; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 19, 2009
• First Posted: August 20, 2009
• Study Start: September 1, 2000
• Primary Completion: January 1, 2006
• Last Updated: August 20, 2009

Record last verified: 2009-08

Locations

BE (1)