NCT00646503已完成4 期
A Single Arm, Multicenter, Open-label, 52-week, the Omnibus Extension Study to Evaluate the Safety and Efficacy of Telbivudine in the Fifth Year of Treatment in Chinese Patients With Compensated Chronic Hepatitis B and Are HBV DNA PCR Negative at the End of Year 4 Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Proportion of patients experiencing serious adverse events (for all SAEs, and SAEs attributed to study drug). Proportion of patients experiencing adverse events, coded by body system ( all AEs, and AEs attributed to study drug).
研究概览
简要总结
This study will explore efficacy and safety of Telbivudine in the fifth year 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
- 18 Years 至 —（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
1
Experimental
600 mg/day, oral telbivudine for 52 weeks
干预措施: Telbivudine (Drug)
结局指标
主要结局
Proportion of patients experiencing serious adverse events (for all SAEs, and SAEs attributed to study drug). Proportion of patients experiencing adverse events, coded by body system ( all AEs, and AEs attributed to study drug).
时间窗: At Baseline, Week 24 and Week 52
次要结局
- For HBeAg-positive patients, Maintained Virologic Response, here defined as HBeAg loss and serum HBV DNA PCR negative (COBAS Amplicor PCR < 300 copies/ml) during the whole study period.(At Baseline, Week 24 and Week 52)
研究者
研究点 (1)
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