NCT00862706撤回4 期
An Open-label, Single-arm, Multicenter, Study of Telbivudine in Nucleos(t)Ide-naïve Subjects of Black/African American or Hispanic/Latino Origin With Compensated Chronic Hepatitis B Virus (HBV) Infection
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 6
- 主要终点
- non detectable HBV DNA level
研究概览
简要总结
The purpose of this study is to investigate the efficacy of telbivudine in Blacks/African Americans and Hispanics/Latinos with compensated chronic hepatitis B during 52 weeks of treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
A
Experimental
干预措施: Telbivudine/LDT600A (Drug)
结局指标
主要结局
non detectable HBV DNA level
时间窗: week 52
次要结局
- Mean and median reduction in HBV DNA(weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 52 or premature D/C)
- Mean and median reduction from Baseline in absolute ALT level(weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 52 or premature D/C)
- Proportion of patients with ALT normalization(weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 52 or premature D/C)
- Proportion of patients with non-detectable serum HBV DNA(week 24)
- of patients with HBeAg loss in subjects who were HBeAg positive at Baseline(Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 52 or premature D/C)
- Proportion of patients with HBeAg seroconversion in subjects who were HBeAg positive at Baseline(2, 4, 8, 12, 16, 24, 32, 40, 48 and 52 or premature D/C)
研究者
研究点 (6)
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