NCT01063829已完成2 期
A Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Safety, Tolerability and Antiviral Activity of 12 Weeks' Treatment With a New Antiviral HCMV Drug
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 133
- 试验地点
- 24
- 主要终点
- Number of Participants With "HCMV Prophylaxis Failure"
研究概览
简要总结
The aim of the study is to find out whether AIC246 is safe and efficacious in lowering the chances of the cytomegalovirus becoming active again and causing illness after an HBPC transplant (allogeneic stem cell transplant).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Seropositive for HCMV IgG antibodies before transplantation
- •First allogeneic Human blood precursor cell (HBPC) transplantation performed for 1 of the following diagnoses: leukaemia, lymphoma, Hodgkin's lymphoma, non-Hodgkin's lymphoma, multiple myeloma, myelodysplastic and myeloproliferative disorder
- •Evidence of post transplantation engraftment
- •Able to swallow tablets.
排除标准
- •Previous anti-HCMV therapy after this allogeneic HBPC transplantation
- •Mismatched or cord blood transplant recipients
- •Current or history of end-organ HCMV disease
- •Graft versus host disease (GVHD)
- •Impaired liver function
- •Reduced renal function
研究组 & 干预措施
Dose regimen 1
Experimental
60 mg AIC246, one tablet per day
干预措施: 60 mg AIC246 (Drug)
Dose regimen 2
Experimental
120 mg AIC246, one tablet per day
干预措施: 120 mg AIC246 (Drug)
Dose regimen 3
Experimental
240 mg AIC246, one tablet per day
干预措施: 240 mg AIC246 (Drug)
Placebo
Other
Placebo arm
干预措施: Placebo (Other)
结局指标
主要结局
Number of Participants With "HCMV Prophylaxis Failure"
时间窗: 84 days
Time to Onset of "HCMV Prophylaxis Failure"
时间窗: 84 days
次要结局
- Number of Patients With Systemic Detectable HCMV Replication.(84 days)
研究者
研究点 (24)
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