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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00863785
First Posted: March 18, 2009
Last Update Posted: October 20, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Centre Hospitalier Universitaire, Amiens
March 17, 2009
March 18, 2009
October 20, 2009
April 2004
August 2009   (Final data collection date for primary outcome measure)
Survival at one, three and six months [ Time Frame: six months ]
Same as current
Complete list of historical versions of study NCT00863785 on ClinicalTrials.gov Archive Site
bilirubin decrease at day seven survival at one and three months nac tolerance side effects [ Time Frame: one, three and six months ]
Same as current
Not Provided
Not Provided
 
Treatment of Severe Alcoholic Hepatitis With Corticoids Plus N Acetyl Cysteine Versus Corticoids Alone
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
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
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Alcoholic Hepatitis
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 Name: AAH-NAC study
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
Intervention: Drug: Corticoids plus N Acetyl Cysteine
Nguyen-Khac E, Thevenot T, Piquet MA, Benferhat S, Goria O, Chatelain D, Tramier B, Dewaele F, Ghrib S, Rudler M, Carbonell N, Tossou H, Bental A, Bernard-Chabert B, Dupas JL; AAH-NAC Study Group. Glucocorticoids plus N-acetylcysteine in severe alcoholic hepatitis. N Engl J Med. 2011 Nov 10;365(19):1781-9. doi: 10.1056/NEJMoa1101214.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
174
September 2009
August 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00863785
PHRC R04 - Dr NGUYEN-KHAC
AFSSAPS 040276
Yes
Not Provided
Not Provided
Amiens University Hospital
Centre Hospitalier Universitaire, Amiens
Not Provided
Study Director: Phillippe DOMY Centre Hospitalier Universitaire, Amiens
Centre Hospitalier Universitaire, Amiens
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP