NCT01829685Unknown4 期
A 3-year, Open-lable, Multi-center Extension Trial of Entecavir Therapy for Patients Previously Treated in Dragon Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 360
- 试验地点
- 16
- 主要终点
- Percentages of patients achieving HBV DNA< 300copies/mL at week 144 in each group
研究概览
简要总结
The purpose of this study is to compare the long-term efficacy and safety of entecavir 1.0 mg/d + adefovir 10 mg/d with entecavir 0.5 mg/d + adefovir 10 mg/d for chronic hepatitis B patients with inadequate response to NUC therapy
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
- •Subjects who completed the 104-week Dragon study.
- •Subjects who are willing to participate the extension study.
排除标准
- •Subjects who could not compliance with the protocol judged by investigators
研究组 & 干预措施
Group I
Active Comparator
oral entecavir 1mg daily and adefovir 10mg daily for 144 weeks
干预措施: Entecavir, Adefovir (Drug)
Group II
Active Comparator
oral entecavir 0.5mg daily and adefovir 10mg daily for 144 weeks
干预措施: Entecavir, Adefovir (Drug)
结局指标
主要结局
Percentages of patients achieving HBV DNA< 300copies/mL at week 144 in each group
时间窗: Week 144
次要结局
- Percentage of patients with HBeAg loss or HBeAg seroconversion at week 48/96/144.(Week 48 & 96 & 144)
- Percentage of patients with ALT normalization at week 48/96/144(Week 48 & 96 & 144)
- Percentages of patients achieving HBV DNA <300copies/mL at week 48/96 in each group.(Week 48 & 96)
- The log10 reduction in HBV DNA from baseline of DRAGON study at week 48/96/144.(Week 48 & 96 &144)
研究者
研究点 (16)
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