NCT00409019撤回4 期
A Prospective, Randomized, Trial to Investigate the Effect of Continued Adefovir Versus Combination Regimens of Telbivudine Plus Adefovir, and Telbivudine Plus Tenofovir in Patients With Chronic Hepatitis B and Suboptimal Viral Suppression (PROACTIV Study)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
研究概览
简要总结
The purpose of this study is to find out if taking a combination of telbivudine and adefovir or tenofovir and telbivudine can lower the amount of Hepatitis B virus in patients that have been taking adefovir alone for at least 5 months and have had less than optimal responses. The safety of taking telbivudine and adefovir together or tenofovir and telbivudine together will also be studied.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 chronic hepatitis B
- •Patient is currently receiving Hepsera (adefovir dipivoxil) and has received treatment continuously for a minimum of 5 months prior to screening.
- •Other 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 nucleoside(tide) therapy other than adefovir
- •Patient previously received an interferon-based treatment or an investigational agent for hepatitis B in the preceding 12 months
- •Other exclusion criteria may apply.
研究组 & 干预措施
1
Experimental
Study cancelled: Withdrawn before enrollment of any participants
干预措施: Telbivudine (Drug)
2
Experimental
Study cancelled: Withdrawn before enrollment of any participants
干预措施: Adefovir (Drug)
3
Experimental
Study cancelled: Withdrawn before enrollment of any participants
干预措施: Tenofovir (Drug)
研究者
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