PROlonged Corticosteroid treatment or N-ACetylcysteine for severe alcoholic hepatitis (PROCORNAC)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 477
- 试验地点
- 20
- 主要终点
- 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
研究概览
简要总结
To assess the efficacy of the combination of N-acetylcysteine during 5 days with standard treatment by prednisolone (prednisolone during 30 days) or a prolonged treatment with prednisolone (during a total of 60 days) compared to standard treatment with prednisolone during 30 days to improve the rate of alive patients with compensated liver disease at 90 days.
研究设计
- 分配方式
- Randomized
- 主要目的
- Measures to Minimize Bias: Randomization and Blinding
- 盲法
- Double (Investigator, Monitor, Subject)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-75
- •Alcohol consumption of more than 40g/day (women) and 50g/day (men)
- •Recent onset of jaundice (<3 months)
- •Biopsy proven alcoholic hepatitis (transjugular liver biopsy)
- •Maddrey’s discriminant function ≥ 32, defining severe alcoholic hepatitis
- •MELD score ≥ 17
- •Patients covered with social insurance
- •Patients having provided written informed consent to participate
排除标准
- •Hepatocellular carcinoma
- •Untreated bacterial infection. Patients on antibiotics to treat ongoing infection can be included if the investigator feels the sepsis is under control.
- •Tuberculosis < 5 years
- •Positive blood PCR in patients with positive antibodies against HCV
- •Patient carrying HBV or HIV
- •Treatment with corticosteroids, immunosuppression therapy or budesonide within 6 months before the study
- •Uncontrolled gastrointestinal bleeding
- •Previous severe allergy or hypersensitivity to N-acetylcysteine (anaphylactic shock, Quincke edema, severe urticaria)
- •Hypersensitivity to any component of the medication
- •MELD score <17
- •Type 1 hepatorenal syndrome before the initiation of treatment
- •Severe extrahepatic disease, with life expectancy < 6 months
- •Any malignant tumor < 2 years (except skin carcinomas)
- •Ongoing viral or parasitic infection
结局指标
主要结局
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
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
次要结局
- - 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
研究者
Prof. Alexandre Louvet
Scientific
Centre Hospitalier Universitaire De Lille