A Phase 3 interventional study of Corticoids plus N Acetyl Cysteine in Alcoholic Hepatitis, sponsored by Centre Hospitalier Universitaire, Amiens. Completed at 13 sites in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2009-10-20.
Sponsored by Centre Hospitalier Universitaire, Amiens · Phase 3, Interventional, and Treatment
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
108 studies on the registry are indexed under Hepatitis, Alcoholic; 23 are open to participants now.
This study's enrollment of 174 is above the median of 60 across 76 interventional studies indexed under Hepatitis, Alcoholic.
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Exclusion Criteria:
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
Also known as: AAH-NAC study
Survival at one, three and six months
Time frame: six months
bilirubin decrease at day seven survival at one and three months nac tolerance side effects
Time frame: one, three and six months
This study is completed, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire, Amiens →