Efficacy and Safety of S-adenosyl-L-methionine in Treatment of Chronic Hepatitis B Patients With Cholestasis
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Gamma-Glutamyl Transpeptidase
研究概览
简要总结
This is an evaluation of adenosine methionine for treatment of chronic hepatitis b patients with cholestasis efficacy and safety of multicenter, randomized, open label clinical trial.
详细描述
evaluation of adenosine methionine for treatment of chronic hepatitis b patients with cholestasis efficacy and safety
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •from 18-65 years old
- •diagnosed as hepatitis B, previous has HBV or HBsAg(+)>6 months, and now HBsAg or HBV DNA(+)
- •with intrahepatic cholestasis: meet EASL 2009 diagnoses criteria ALP>1.5ULN and GGT>3ULN or STB>2ULN
排除标准
- •liver mass, liver carcinoma
- •liver failure
- •non-hepatic diseases caused jaundice
- •obstructive jaundice
研究组 & 干预措施
Ademetionine 1
Ademetionine 2000mg
干预措施: Ademetionine 1 (Drug)
Ademetionine 2
Ademetionine 1000mg
干预措施: Ademetionine 2 (Drug)
Ademetionine 3
no treatment in first 2 weeks, then Ademetionine 1000mg bid po with general antiviral treatment for 8 weeks
干预措施: Ademetionine 3 (Drug)
结局指标
主要结局
Gamma-Glutamyl Transpeptidase
时间窗: 10 weeks
Gamma-Glutamyl Transpeptidase
Alkaline Phosphatase
时间窗: 10 weeks
Alkaline Phosphatase
levels of serum total bilirubin declined from baseline
时间窗: 2 weeks
levels of serum total bilirubin declined from baseline
次要结局
- glutamic pyruvic transaminase(2 weeks, 6 weeks, 10 weeks)
- glutamic oxaloacetic transaminase(2 weeks, 6 weeks, 10 weeks)
- level of serum bile acids decline from baseline(2 weeks, 6 weeks, 10 weeks)
- level of serum direct bilirubin decline from baseline(2 weeks, 6 weeks, 10 weeks)