N-Acetylcysteine in Severe Acute Alcoholic Hepatitis

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00962442

Enrollment

Registered

2009-08-20

Start date

2000-09-30

Completion date

Unknown

Last updated

2009-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcoholic Hepatitis

Keywords

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

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.

Interventions

DRUGN-Acetylcysteine

300 mg/kg for 14 days, intravenously

DRUGplacebo

Glucosé 5% perfusion for 14 days, intravenously

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Six months survival	—

Secondary

Measure	Time frame
Rate of infections, clinical and biological parameters	—

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026