CompletedPhase 3

Treatment of Severe Alcoholic Hepatitis With Corticoids Plus N Acetyl Cysteine Versus Corticoids Alone

France174 participantsStarted 2004-04

Plain-language 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 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

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Survival at one, three and six months

Timeframe: six months

Trial details

NCT IDNCT00863785

SponsorCentre Hospitalier Universitaire, Amiens

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-08

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