NCT01529255Unknown4 期
A 3-year, Open-label, Multi-center Extension Trial of Telbivudine Therapy for Patients Previously Treated in EFFORT Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 576
- 试验地点
- 24
- 主要终点
- The difference of percentage of patients achieving HBV DNA< 300copies/mL at week 48 in Group I and Group II
研究概览
简要总结
- The purpose of this study is to to prove that the long-term efficacy of strategy of treatment adjustment at W24 according to virological response based on ROADMAP concept is better than standard of care strategy.
- To evaluate the off-treatment durability of HBeAg seroconversion in patients who discontinued treatment due to sustained HBeAg seroconversion and HBV DNA<300copies/ml with over 12 months consolidation treatment
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
- •Treated with telbivudine or combined with adefovir in EFFORT study
- •Patients are willing to participate in the extension study
- •Patients provide information consent form
排除标准
- •Adjustment of poor compliance by investigators
研究组 & 干预措施
ROADMAP
Experimental
干预措施: telbivudine (ROADMAP) (Drug)
SOC (Standard of Care)
Active Comparator
干预措施: Telbivudine (Standard of Care) (Drug)
结局指标
主要结局
The difference of percentage of patients achieving HBV DNA< 300copies/mL at week 48 in Group I and Group II
时间窗: Week 48
次要结局
- Percentage of patients achieving HBV DNA <300copies/mL at week 156(Week 156)
- The log10 reduction in HBV DNA from baseline of EFFORT study at week 156(Week 156)
- Percentage of patients with HBeAg loss or HBeAg seroconversion at week 156(Week 156)
- Percentage of patients with HBsAg loss or HBsAg seroconversion at week 156(Week 156)
- The percentage of patients with ALT normalization at week 156(Week 156)
- Percentage of patients with HBV DNA breakthrough at week 156(Week 156)
- Percentage of patients with genotypic resistance among the patients with HBV DNA breakthrough at week 156(Week 156)
- sustained response rate of durability of HBeAg seroconversion at week 52 of off-treatment duration(week 52 of off-treatment)
- percentage of hepatitis flare at week 52 of off-treatment duration(week 52 of off-treatment)
研究者
研究点 (24)
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