An Open-Label, Randomized, Adaptive, Two-Arm, Multicenter Trial to Evaluate Pharmacokinetics And Pharmacodynamics of Two Doses of Oseltamivir (Tamiflu®) in The Treatment Of Influenza in Immunocompromised Children Less Than 13 Years Of Age, With Confirmed Influenza Infection
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 50
- 主要终点
- Steady State AUC0-12 of Oseltamivir Carboxylate
研究概览
简要总结
This open-label, randomized, adaptive, 2-arm, multicenter study will evaluate the pharmacokinetics and pharmacodynamics of oseltamivir (Tamiflu) in immunocompromised children, less than (<) 13 years of age, with confirmed influenza infection. Participants will be randomized to receive either the standard dose or triple dose of oseltamivir orally daily for a minimum of 5 days and up to 20 days. Infants <1 year of age will be randomized to the standard dose arm only.
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
- — 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female children, <13 years of age
- •Rapid influenza diagnostic test (RIDT), polymerase chain reaction (PCR), or viral culture positive for influenza
- •Immunocompromised
- •Symptoms/signs suggestive of influenza like illness (ILI)
- •Less than or equal to (</=) 96 hours between onset of ILI and first dose of study drug
排除标准
- •Clinical evidence of severe hepatic impairment
- •Infants with post-menstrual age (PMA) <36 weeks
- •Clinical evidence of significant renal impairment
- •Allergy to oseltamivir or excipients
- •Hereditary fructose intolerance
- •Received anti-viral treatment with activity against influenza (for example amantadine, rimantadine, oseltamivir, laninamivir, peramivir, zanamivir, and ribavirin) or probenecid medication within 2 weeks prior to randomization
研究组 & 干预措施
Oseltamivir: Standard dose
Participants will receive standard dose of oseltamivir capsules or suspension orally for 5 to maximum of 20 days depending on weight. Infants <1 year of age will receive oseltamivir at a dose of 3 milligrams per kilogram (mg/kg).
干预措施: Oseltamivir (Drug)
Oseltamivir: Triple dose
Participants will receive three times the standard dose of oseltamivir capsules or suspension orally for 5 to maximum of 20 days depending on weight and age. Infants <1 year will receive standard dose at 3 mg/kg.
干预措施: Oseltamivir (Drug)
结局指标
主要结局
Steady State AUC0-12 of Oseltamivir Carboxylate
时间窗: Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4
Cmax of Oseltamivir Carboxylate
时间窗: Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4
Trough Plasma Concentration (Ctrough) of Oseltamivir
时间窗: Pre-dose (within 30 minutes prior to administration) on Days 3 or 4
Steady State Area Under the Concentration-Time Curve From Time 0 to 12 Hours (AUC0-12) of Oseltamivir
时间窗: Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4
Time to Cessation of Viral Shedding, as Assessed by Polymerase Chain Reaction (PCR) or Culture Testing
时间窗: From randomization to negative PCR/culture test result (up to Day 50)
Ctrough of Oseltamivir Carboxylate
时间窗: Pre-dose (within 30 minutes prior to administration) on Days 3 or 4
Maximum Plasma Concentration (Cmax) of Oseltamivir
时间窗: Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4
次要结局
- Number of Participants With Influenza Associated Complications(Baseline up to Day 50)
- V/F of Oseltamivir Carboxylate(Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4)
- Number of Participants With Adverse Events(Baseline up to Day 50)
- Half-life (t1/2) of Oseltamivir(Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4)
- Time to Maximum Concentration (Tmax) of Oseltamivir(Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4)
- Apparent Volume of Distribution (V/F) of Oseltamivir(Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4)
- Time to Last Measurable Concentration (Tlast) of Oseltamivir(Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4)
- t1/2 of Oseltamivir Carboxylate(Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4)
- Elimination Rate Constant (Ke) of Oseltamivir(Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4)
- Time to Resolution of Influenza Symptoms (including fever),, as Assessed by Canadian Acute Respiratory Infections Scale (CARIFS)(From randomization to resolution of all influenza symptoms (up to Day 50))
- Tmax of Oseltamivir Carboxylate(Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4)
- Apparent Clearance (CL/F) of Oseltamivir(Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4)
- CL/F of Oseltamivir Carboxylate(Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4)
- Last Measurable Concentration (Clast) of Oseltamivir(Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4)
- Number of Participants With Viral Resistance(Baseline up to Day 50)
- Ke of Oseltamivir Carboxylate(Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4)
- Clast of Oseltamivir Carboxylate(Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4)
- Tlast of Oseltamivir Carboxylate(Pre-dose (within 30 minutes prior to administration), 1.5, 4, 8 hours post-dose on Days 3 or 4)