Safety and Pharmacokinetics of Valganciclovir Syrup Formulation in Pediatric Solid Organ Transplant Recipients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 63
- 主要终点
- Mean Area Under the Concentration-Time Curve From 0 to 24 Hours of Valganciclovir
研究概览
简要总结
This study will assess the safety and pharmacokinetics of Valcyte syrup in pediatric solid organ transplant recipients. The anticipated time on study treatment is 3-12 months and the target sample size is less than 100 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients between 3 months and 16 years of age;
- •first solid organ transplant (eg, kidney, liver, heart);
- •able to tolerate oral medication;
- •females of childbearing potential must agree to utilize an effective method of contraception throughout the study and for 90 days following discontinuation of study drug;
- •patients at risk of developing CMV disease (all transplant recipients other than those who are D-R- for CMV).
排除标准
- •patients who have previously participated in this study;
- •patients who are participating in another clinical trial (except with the approval of the Sponsor);
- •severe, uncontrolled diarrhea (more than 5 watery stools per day);
- •pregnant or lactating females.
研究组 & 干预措施
Valganciclovir Age Group <= 2 Years
Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 milligrams (mg) once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose = 7 * body surface area (BSA) * creatinine clearance (CrCLS).
干预措施: valganciclovir [Valcyte] (Drug)
Valganciclovir Age Group >2 to <12 Years
Eligible participants aged >2 to <12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose = 7 * BSA * CrCLS.
干预措施: valganciclovir [Valcyte] (Drug)
Valganciclovir Age Group >= 12 Years
Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose = 7 * BSA * CrCLS.
干预措施: valganciclovir [Valcyte] (Drug)
结局指标
主要结局
Mean Area Under the Concentration-Time Curve From 0 to 24 Hours of Valganciclovir
时间窗: Pre-dose; 1-3, 3-7, 7-12 hours post dose on any day between Day 7 to Day 14; Week 6, Week 10, and Week 14
Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. The AUC 0-24 hours is area under the plasma concentration-time curve from time zero through 24 hours after dosing. A compartmental model was used to measure the plasma concentrations of valganciclovir. One participant was not analyzed for this outcome measure as the participant underwent both a kidney and liver transplant.
Number of Participants With 3 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry
时间窗: Up to Week 26
The number of participants experiencing a 3 grade shift (example from Grade 0 to Grade 3) from baseline (BL) in hematology and serum chemistry laboratory parameters are reported. The data was analyzed for overall study only.
Number of Participants With 4 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry
时间窗: Up to Week 26
The number of participants experiencing a 4 grade shift (example from Grade 0 to Grade 4) from BL in hematology and serum chemistry laboratory parameters are reported. The data was analyzed for overall study only.
Number of Participants With Adverse Events Leading to Dose Interruption or Modification
时间窗: Up to Week 26
An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation in participant administered a pharmaceutical product, which did not necessarily have to have a causal relationship with this treatment. The number of participants with AEs leading to dose interruptions or modifications are reported.
Number of Participants With Opportunistic Infections
时间窗: Up to Week 26
Opportunistic infections included oral candidiasis, candidiasis, herpes simplex, cytomegalovirus antigen positive, cytomegalovirus test positive. The number of participants with opportunistic infections are reported.
Number of Participants With Any Adverse Events and Any Serious Adverse Events
时间窗: Up to Week 26
An AE was defined as any untoward medical occurrence in a clinical investigation in participant administered a pharmaceutical product, which did not necessarily have to have a causal relationship with this treatment. A serious adverse event (SAE) is any experience or a significant hazard, that is fatal, life-threatening, requires in-patient hospitalization or prolongation of existing one, results in persistent or significant disability, is a congenital anomaly, is medically significant or requires intervention to prevent one or other of the outcomes listed above.
Number of Participants With Adverse Events Leading to Discontinuation of the Study Drug
时间窗: Up to Week 26
An AE was defined as any untoward medical occurrence in a clinical investigation in participant administered a pharmaceutical product, which did not necessarily have to have a causal relationship with this treatment. The number of participants with AEs leading to discontinuation of the study drug is reported.
次要结局
- Mean Maximum Plasma Concentration of Valganciclovir Over Time(Pre-dose; 1-3, 3-7, 7-12 hours post dose on any day between Day (D) 7 to D 14; and at Week (W) 6, W 10, and W 14)
- Mean Elimination Half-Life of Valganciclovir Over Time(Pre-dose; 1-3, 3-7, 7-12 hours post dose on any day between Day 7 to Day 14; Week 6, Week 10, and Week 14)
- Number of Participants Who Experienced Episodes of Rejection Over Time(Up to Week 26)
- Number of Participants With Cytomegalovirus Disease Over Time(Up to Week 26)
- Number of Participants With Treatment Failures(Up to Week 26)
- Number of Participants Who Experienced Graft Loss(Up to Week 26)