NCT00431353已完成4 期
A Randomized, Open-label Study of the Effect of Oral Valcyte Versus Intravenous Ganciclovir on CMV Viremia in Solid Organ Transplant Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 325
- 主要终点
- Incidence of treatment success (CMV viremia BLQ)
研究概览
简要总结
This 2 arm study will evaluate the efficacy and safety of oral Valcyte compared with intravenous ganciclovir for the treatment of CMV disease in solid organ transplant recipients. Eligible patients will be randomized to receive either 1)Valcyte 900mg po bid or 2)ganciclovir 5mg/kg iv bid. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients >=18 years of age;
- •recipients of solid organ(s) transplant;
- •virologic and clinical evidence of CMV disease after transplantation;
- •patients of childbearing potential must be prepared to use effective contraception throughout, and for 90 days after the end of the study.
排除标准
- •life-threatening CMV disease according to the investigator's judgment;
- •pregnant or lactating women.
研究组 & 干预措施
1
Experimental
干预措施: valganciclovir [Valcyte] (Drug)
2
Experimental
干预措施: Ganciclovir (Drug)
结局指标
主要结局
Incidence of treatment success (CMV viremia BLQ)
时间窗: Day 21
次要结局
- Time to eradication of CMV viremia, percentage of patients with resolution of symptoms, percentage of patients with eradication of CMV viremia, time to CMV viremia recurrence, effect on HHV-6, HHV-7 and EBV viremia.(Throughout study)
- AEs, laboratory parameters, appearance of ganciclovir resistance.(Throughout study)
研究者
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