Efficacy and Safety of S-adenosyl-l-methionine in Treatment of Alcoholic Hepatitis With Cholestasis
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- response rate of serum total bilirubin
研究概览
简要总结
To determine the efficacy and safety S-adenosyl-l-methionine in alcoholic hepatitis with cholestasis.
详细描述
randomize first time for core treatment stage for 6 weeks, then randomized second time for extend treatment for 42 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body Mass Index range 19-30kg/m2
- •Alcohol Drinking history more than 5 years, for male ≥ 40g/ day, for female ≥ 20g/ day;
- •STB from 2 to 10X ULN;
- •ALP>1.5X ULN or GGT>3X ULN
排除标准
- •any one of below,
- •active virus hepatitis, or anti-HIV(+)
- •exclude other hepatic disease: non-alcoholic fatty liver, drug-induced liver injury, autoimmune hepatitis( AMA/ANA>1:100), Wilson disease, hemochromatosis or other hepatic disease; obstructive cholestasis
- •other non-hepatic diseases caused jaundice
- •primary hepatic carcinoma
研究组 & 干预措施
Ademethionine
ademethionine 1000mg ivgtt qd for 2 weeks, then orally 1000mg bid for 4 weeks.
干预措施: Ademethionine (Drug)
Polyene Phosphatidyl choline
Polyene Phosphatidyl choline 10ml ivgtt qd for 2 weeks, then Polyene Phosphatidyl choline 456 mg tid orally for 4 weeks.
干预措施: Polyene Phosphatidyl choline (Drug)
Polyene Phosphatidyl choline
Polyene Phosphatidyl choline 10ml ivgtt qd for 2 weeks, then Polyene Phosphatidyl choline 456 mg tid orally for 4 weeks.
干预措施: Ademethionine (Drug)
结局指标
主要结局
response rate of serum total bilirubin
时间窗: 6 weeks
response rate means percentage of subjects whose serum total bilirubin values declined from baseline over 30%
次要结局
- level of serum direct bilirubin(6 weeks and 48 weeks)
- level of serum bile acids(6 weeks and 48 weeks)
- level of glutamic pyruvic transaminase(6 weeks and 48 weeks)
- level of glutamic oxaloacetic transaminase(6 weeks and 48 weeks)
- level of alkaline phosphatase(6 weeks and 48 weeks)
- level of gamma-glutamyl transpeptidase(6 weeks and 48 weeks)
- level of hyaluronic acid(6 weeks and 48 weeks)