Status:
COMPLETED
Treatment of Severe Alcoholic Hepatitis With Corticoids Plus N Acetyl Cysteine Versus Corticoids Alone
Lead Sponsor:
Centre Hospitalier Universitaire, Amiens
Conditions:
Alcoholic Hepatitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
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 ...
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 ...
Eligibility Criteria
Inclusion
- Patient consent
- Chronic alcohol intake in the last 3 to 6 months
- Maddrey score ≥ 32
- Liver histology compatible
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT00863785
Start Date
April 1 2004
End Date
September 1 2009
Last Update
October 20 2009
Active Locations (13)
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1
Centre Hospitalier d'Abbeville
Abbeville, France
2
Centre Hospitalier Beauvais
Beauvais, France, 60000
3
Centre Hospitalier Universitaire de Besançon
Besançon, France, 25030
4
Centre Hospitalier Universitaire de Caen
Caen, France, 14000