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N-Acetylcysteine in Severe Acute Alcoholic Hepatitis

Primary Purpose

Alcoholic Hepatitis

Status
Completed
Phase
Phase 3
Locations
Belgium
Study Type
Interventional
Intervention
N-Acetylcysteine
placebo
Sponsored by
Erasme University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholic Hepatitis focused on measuring alcoholic hepatitis, N-Acetylcysteine, enteral nutrition, oxidative stress, severe acute alcoholic hepatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Erasme University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

nutritional support + N-Acétylcysteine

nutritional support + placebo

Arm 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

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

Outcomes

Primary Outcome Measures

Six months survival

Secondary Outcome Measures

Rate of infections, clinical and biological parameters

Full Information

First Posted
August 19, 2009
Last Updated
August 19, 2009
Sponsor
Erasme University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00962442
Brief Title
N-Acetylcysteine in Severe Acute Alcoholic Hepatitis
Official Title
N-Acetylcysteine for the Treatment of Alcoholic Hepatitis: a Belgian Multicenter Randomised Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Erasme University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholic Hepatitis
Keywords
alcoholic hepatitis, N-Acetylcysteine, enteral nutrition, oxidative stress, severe acute alcoholic hepatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
nutritional support + N-Acétylcysteine
Arm Type
Active Comparator
Arm 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
Arm Title
nutritional support + placebo
Arm Type
Placebo Comparator
Arm Description
placebo perfusion for 14 days Beside usual meals patients must receive at least 27 kcal/kg/day enteral nutrition for 14 days
Intervention Type
Drug
Intervention Name(s)
N-Acetylcysteine
Intervention Description
300 mg/kg for 14 days, intravenously
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Glucosé 5% perfusion for 14 days, intravenously
Primary Outcome Measure Information:
Title
Six months survival
Secondary Outcome Measure Information:
Title
Rate of infections, clinical and biological parameters

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Erasme University Hospital
City
Brussels
ZIP/Postal Code
1070
Country
Belgium

12. IPD Sharing Statement

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N-Acetylcysteine in Severe Acute Alcoholic Hepatitis

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