Tolerability of up to 200 Days of Valganciclovir Oral Solution or Tablets in Pediatric Kidney Transplant Recipients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 25
- 主要终点
- Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) or Withdrawal Due to AEs
研究概览
简要总结
This open-label, single arm study will evaluate the tolerability and efficacy of Valcyte (valganciclovir) in the prevention of cytomegalovirus disease in pediatric renal transplant recipients. After transplantation, patients (aged 4 months to 16 years) will receive Valcyte orally daily for up to 200 days post-transplant and will be followed for 52 weeks post-transplantation.
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
- 4 Months 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children, 4 months to 16 years of age
- •Patient has received a kidney transplant
- •At risk of developing cytomegalovirus disease
- •Adequate hematological and renal function
- •Able to tolerate oral medication
- •Negative pregnancy test for females of childbearing potential
排除标准
- •Allergic or significant adverse reaction to acyclovir, valacyclovir or ganciclovir in the past
- •Severe uncontrolled diarrhea (more than 5 watery stools per day)
- •Liver enzyme elevation of more than five times the upper limit of normal for aspartate aminotransferase [AST (SGOT)] or alanine aminotransferase [ALT (SGPT)]
- •Patient requires use of any protocol prohibited concomitant medication
- •Previous participation in this clinical study
研究组 & 干预措施
Valganciclovir
Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in milligrams) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
干预措施: valganciclovir [Valcyte] (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) or Withdrawal Due to AEs
时间窗: 52 weeks
An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. Pre-existing conditions which worsen during a study were reported as AEs. A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant.
次要结局
- Number of Participants With Cytomegalovirus (CMV) Infection in the First 52 Weeks Post-Transplant as Assessed by the Investigator(52 weeks)
- Number of Participants With Cytomegalovirus (CMV) Disease in the First 52 Weeks Post-Transplant as Assessed by the Investigator(52 weeks)
- Number of Participants With Peak Cytomegalovirus (CMV) Viral Load up to Week 52 Post-Transplant(52 weeks)
- Number of Participants With Biopsy Proven Rejection(52 Weeks)
- Number of Participants With Graft Loss(52 Weeks)
- Number of Participants With Death(52 Weeks)
- Number of Participants With Known Ganciclovir Resistance (Mutations in Either UL54 or UL97 Genes)(52 Weeks)