NCT00132652已完成3 期
A Randomized Trial of Switching Antiviral Therapy From Lamivudine to Telbivudine (LdT) vs. Continued Lamivudine Treatment in Adults With Chronic Hepatitis B
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 240
- 试验地点
- 14
研究概览
简要总结
This study is being conducted to compare the safety and effectiveness of switching treatment from lamivudine to telbivudine (LdT) against continued lamivudine treatment. Results from patients who were taking lamivudine and then switched to telbivudine will be compared with the results from patients who continued on lamivudine alone.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented clinical history compatible with chronic hepatitis B
- •Patient has compensated liver disease
- •Patient has received previous treatment with lamivudine for a duration of at least 3 months and not more than 12 months
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Patient is pregnant or breastfeeding
- •Patient is co-infected with hepatitis C, hepatitis D or HIV
- •Patient previously received antiviral treatment for hepatitis B other than lamivudine in the preceding 12 months
- •Other protocol-defined exclusion criteria may apply.
研究者
研究点 (14)
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