NCT00223925已完成2 期
A Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Assess the Safety, Tolerability, and Prophylactic Anti-cytomegalovirus Activity of Maribavir in Recipients of Allogeneic Stem Cell Transplants
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 111
- 试验地点
- 13
- 主要终点
- Clinical safety as measured by the recording of treatment emergent adverse events
研究概览
简要总结
Cytomegalovirus (CMV) infections remain a significant problem following various types of transplants that are associated with strong immunosuppressive therapy. Maribavir is a new oral anti-CMV drug with a novel mechanism of action compared to currently available anti-CMV drugs. This study will test the safety and anti-CMV activity of different doses of maribavir when given as CMV prophylaxis following stem cell transplants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
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
- •Allogeneic stem cell transplant recipient
- •Recipient CMV seropositive
- •Have transplant engraftment
- •Able to swallow tablets
排除标准
- •CMV organ disease
- •HIV infection
- •Use of other anti-CMV therapy post-transplant
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Maribavir (100 mg twice daily)
Experimental
干预措施: Maribavir (Drug)
Maribavir (400 mg twice daily)
Experimental
干预措施: Maribavir (Drug)
Maribavir (400 mg once daily)
Experimental
干预措施: Maribavir (Drug)
结局指标
主要结局
Clinical safety as measured by the recording of treatment emergent adverse events
时间窗: 13 weeks
次要结局
- Incidence of CMV disease(13 weeks)
- Incidence of CMV infection(13 weeks)
研究者
研究点 (13)
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