Treatment of Severe Alcoholic Hepatitis With Corticoids Plus N Acetyl Cysteine Versus Corticoids Alone (HAA-NAC)

October 19, 2009 updated by: Centre Hospitalier Universitaire, Amiens

Treatment of Acute Severe Alcoholic Hepatitis With Corticoids Plus N Acetyl Cysteine Versus Corticoids Alone: a French Multicentre Randomized Controlled Study.

35% of Acute Alcoholic Hepatitis patients (AAH) do not respond to corticoids and died after 6 months. Chronic alcohol abuse depletes glutathione in the hepatocytes and makes the latter more sensitive to excessive TNFα levels. Re-establishment of a stock of antioxidants by administration of a precursor (N-acetyl cysteine, NAC) in combination with corticoids (C) could make the hepatocytes more resistant and improve survival. The investigators' study's primary endpoint was improvement of survival at 6 months. The secondary endpoints were survival at 1 and 3 months, tolerance of NAC and a drop in blood bilirubin levels at D7

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

AAH patients (Maddrey score > 32 and compatible histological results) should centrally randomized into the C-NAC or C groups. Both groups received 4 weeks of prednisolone treatment, plus NAC for the combination therapy group (D1: 150, 50 and 100 mg/kg in 250, 500 and 1000 mL of 5% glucose-saline (G5%) respectively, at t=30 minutes, 4 and 16 hours; D2 to D5, 100 mg/kg in 1000 mL of G5%). Group C received 1000 mL of G5%, D1-5

Study Type

Interventional

Enrollment (Actual)

174

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Abbeville, France
        • Centre Hospitalier d'Abbeville
      • Beauvais, France, 60000
        • Centre Hospitalier Beauvais
      • Besancon, France, 25030
        • Centre Hospitalier Universitaire de Besançon
      • Caen, France, 14000
        • Centre Hospitalier Universitaire de Caen
      • Cambrai, France
        • Centre Hospitalier de Cambrai
      • Compiegne, France
        • Centre Hospitalier de Compiegne
      • Lens, France
        • Centre Hospitalier de LENS
      • Paris, France
        • Centre hospitalier Saint-Antoine
      • Paris, France
        • Centre Hospitalier Universitaire Pitié-Salpétrière
      • Reims, France
        • Centre Hospitalier Universitaire de Reims
      • Rouen, France, 76031
        • Centre Hospitalier Universitaire de Rouen
      • Saint-quentin, France
        • Centre Hospitalier de Saint-Quentin
      • Valenciennes, France
        • Centre Hospitalier de Valenciennes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient consent
  • Chronic alcohol intake in the last 3 to 6 months
  • Maddrey score ≥ 32
  • Liver histology compatible

Exclusion Criteria:

  • Hepato renal syndrome
  • Hepatocarcinoma
  • Recent variceal haemorrhage
  • Recent bacterial infections
  • Other liver diseases associated (HCV, HBV, hemochromatosis, AIH)
  • Cancers or cardiac and respiratory, HIV infection
  • NAC Allergy
  • No patient consent
  • Acetaminophen intoxication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Corticoids plus N Acetyl Cysteine
40 mg/d prednisolone N Acetyl Cysteine infusion 150mg/kg in 30 minutes then 50 mg/kg in 4 h then 100mg/kg in 16 h and finally 100mg/d2 to d5
Drug: Corticoids plus N Acetyl Cysteine
40 mg/d prednisolone N Acetyl Cysteine infusion 150mg/kg in 30 minutes then 50 mg/kg in 4 h then 100mg/kg in 16 h and finally 100mg/d2 to d5
Other Names:
  • AAH-NAC study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival at one, three and six months
Time Frame: six months
six months

Secondary Outcome Measures

Outcome Measure
Time Frame
bilirubin decrease at day seven survival at one and three months nac tolerance side effects
Time Frame: one, three and six months
one, three and six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Investigators

  • Study Director: Phillippe DOMY, Centre Hospitalier Universitaire, Amiens

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (ACTUAL)

August 1, 2009

Study Completion (ACTUAL)

September 1, 2009

Study Registration Dates

First Submitted

March 17, 2009

First Submitted That Met QC Criteria

March 17, 2009

First Posted (ESTIMATE)

March 18, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

October 20, 2009

Last Update Submitted That Met QC Criteria

October 19, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHRC R04 - Dr NGUYEN-KHAC
  • AFSSAPS 040276

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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