PROlonged Corticosteroid treatment or N-ACetylcysteine for severe alcoholic hepatitis (PROCORNAC)

Condition studied

Alcoholic hepatitis

Investigational medicinal product(s)

Eligibility

Primary endpoint

Rate of patients alive with compensated liver disease defined as a MELD score <17 at 90 days. MELD score will be calculated according to the formula given in Dunn et al. Hepatology 2005: MELD = 9.57 x ln (creatinine in mg/dL) + 3.78 x ln (bilirubin in mg/dL) + 11.2 x ln (INR) + 6.43

Endpoint detail

- Overall survival at 90 and 360 days ; - Rate of patients alive with compensated liver disease defined by a MELD score <17 at 30-days, 60-days,180 and 360 days, Therapeutic response at day 7 assessed by the rate of patients with a Lille score <0.45 as well as the Lille score treated as a continuous variable (assessing the degree of therapeutic response), - Cumulative incidence of infection within the first 90 days; - Cumulative incidence of hepatorenal syndrome within the first 90 days; - Serious adverse events within the first 90 days