NCT00651209已完成4 期
A Single-arm, Multinational, Two Year Study Evaluating the Efficacy and Safety of lead-in Telbivudine for 24 Weeks With or Without Tenofovir Treatment Intensification in Adult Patients With HBeAg-positive Chronic Hepatitis B.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- The primary objective of the study is to determine if telbivudine early non-responders can achieve an antiviral response with the addition of tenofovir.
研究概览
简要总结
This study will evaluate the use of telbivudine for patients with HBeAg-positive CHB with an option to intensify treatment at Week 24 by adding tenofovir for patients who do not achieve HBV DNA non-detectability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
Sub-group 1- continue telbivudine if HBV DNA non-detectable at week 24 Sub-group 2- tenofovir added to telbivudine in patients if HBV DNA detectable at week 24
干预措施: Tenofovir (Drug)
结局指标
主要结局
The primary objective of the study is to determine if telbivudine early non-responders can achieve an antiviral response with the addition of tenofovir.
时间窗: at week 52
次要结局
- To estimate the rate of virologic breakthrough up to week 48 and week 104 To assess the rate of treatment-emergent genotypically confirmed HBV resistance associated with viral breakthrough up to weeks 48 and 104 and 104(at week 52 and 104)
研究者
研究点 (1)
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