NCT00115245已完成3 期
A Randomized, Open-Label Trial of Telbivudine Versus Adefovir Dipivoxil in Adults With HBegAg-Positive, Compensated 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
- 试验地点
- 15
研究概览
简要总结
This research study is being conducted to compare the safety and effectiveness of the investigational medication, LdT (telbivudine) versus adefovir dipivoxil, a drug approved by the Food and Drug Administration (FDA) for the treatment of hepatitis B infection. The results for patients taking LdT will be compared to results for patients taking adefovir dipivoxil.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented compensated chronic hepatitis B defined by clinical history compatible with compensated chronic hepatitis B
- •Detectable serum HBsAg at the Screening visit
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Patient is pregnant or breastfeeding.
- •Patient is coinfected with hepatitis C virus (HCV), hepatitis D virus (HDV) or HIV
- •Patient previously received lamivudine, adefovir dipivoxil, or an investigational anti-hepatitis B virus (HBV) nucleoside or nucleotide analog at any time
- •Patient has received interferon or other immunomodulatory treatment for HBV infection in the 12 months before screening for this study
- •Other protocol-defined exclusion criteria may apply.
研究者
研究点 (15)
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