NCT01165580已完成1 期
Pharmacokinetics and Safety of Valganciclovir in Pediatric Heart Transplant Recipients < 4 Months of Age
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 主要终点
- Area under plasma concentration versus time curve of ganciclovir
研究概览
简要总结
This open label study will assess the pharmacokinetics and the safety and tolerability of Valcyte (valganciclovir) powder for oral solution in neonatal and infant heart transplant patients < 4 months of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 124 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females, 0 to < 4 months (< 125 days) of age at the time of the last PK assessment in this study
- •Parent or guardian of the patient is willing and able to give written informed consent
- •Patient has received a first heart transplant
- •Patient is at risk of developing cytomegalovirus (CMV) disease and is being treated with i.v. ganciclovir or oral valganciclovir for prevention of CMV
- •Adequate hematological and renal function
- •Able to tolerate oral medication (any appropriate form of tube feeding is acceptable)
排除标准
- •Allergic or significant adverse reaction to acyclovir, valacyclovir or ganciclovir in the past
- •Severe, uncontrolled, clinically abnormal diarrhea
- •Liver enzyme elevation of more than five times the upper limit of normal for AST (SGOT) or ALT (SGPT)
- •Patient requires use of any protocol prohibited concomitant medications
- •Patient has previously participated in this clinical trial
研究组 & 干预措施
Single Arm
Experimental
干预措施: valganciclovir [Valcyte] (Drug)
结局指标
主要结局
Area under plasma concentration versus time curve of ganciclovir
时间窗: 0, 1-3, 3-7, 7-12, 24 hours post-dose
Apparent volume of distribution of ganciclovir
时间窗: 0, 1-3, 3-7, 7-12, 24 hours post-dose
Terminal half-life of ganciclovir
时间窗: 0, 1-3, 3-7, 7-12, 24 hours post-dose
Peak concentration of ganciclovir
时间窗: 0, 1-3, 3-7, 7-12, 24 hours post-dose
次要结局
- Safety (Incidence of adverse events)(9 days)
研究者
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