A Multicenter, Randomized, Double-Blind, Active (Oseltamivir)-Controlled Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Otherwise Healthy Pediatric Patients 1 to <12 Years of Age With Influenza-Like Symptoms
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 173
- 试验地点
- 37
- 主要终点
- Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
This study will evaluate the safety, pharmacokinetics, and efficacy of baloxavir marboxil compared with oseltamivir in a single influenza episode in otherwise healthy pediatric participants (i.e., 1 to <12 years of age) with influenza-like symptoms.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 1 Year 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 1 to < 12 years at randomization (Day 1).
- •Written informed consent/assent for study participation obtained from participant's parents or legal guardian, with assent as appropriate by the participant, depending on the patient's level of understanding
- •Participant able to comply with study requirements, depending on the patient's level of understanding
- •Participant with a diagnosis of influenza virus infection confirmed by the presence of all of the following:
- •Fever ≥ 38 degree celsius (tympanic temperature) at screening
- •At least one respiratory symptom (either cough or nasal congestion)
- •The time interval between the onset of symptoms and screening is ≤ 48 hours
排除标准
- •Severe symptoms of influenza virus infection requiring inpatient treatment
- •Concurrent infections requiring systemic antiviral therapy at screening
- •Require, in the opinion of the investigator, any of the prohibited medication during the study
- •Previous treatment with peramivir, laninamivir, oseltamivir, zanamivir, or amantadine within 2 weeks prior to screening
- •Immunization with a live/attenuated influenza vaccine in the 2 weeks prior to randomization
- •Concomitant treatment with steroids or other immuno-suppressant therapy
- •Known HIV infection or other immunosuppressive disorder
- •Uncontrolled renal, vascular, neurologic, or metabolic disease (e.g., diabetes, thyroid disorders, adrenal disease), hepatitis, cirrhosis, or pulmonary disease or participants with known chronic renal failure.
- •Active cancer at any site
- •History of organ transplantation
- •Known allergy to either study drug (i.e., baloxavir marboxil and oseltamivir) or to acetaminophen
- •Females with child-bearing potential
- •Participation in a clinical trial within 4 weeks or five half-lives of exposure to an investigational drug prior to screening, whichever is longer
研究组 & 干预措施
Baloxavir Marboxil
Participants will receive a single oral dose of baloxavir marboxil on Day 1 (based on body weight). Oseltamivir matching placebo will also be administered orally twice daily (BID) for 5 days.
干预措施: Baloxavir Marboxil (Drug)
Oseltamivir
Participants will receive oseltamivir orally BID for 5 days (based on body weight). Baloxavir marboxil matching placebo will also be administered orally on Day 1
干预措施: Oseltamivir (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Up to Day 29
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be 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. A serious adverse event (SAE) is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/ incapacity, is a congenital anomaly/ birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above.
次要结局
- Plasma Concentrations of S-033447 - Extensive PK Population(Days 1 (Post-Dose), 2, 4, 6 and 10)
- Plasma Concentrations of S-033447 - Sparse PK Population(Days 1 (Post-Dose), 2, 4, 6 and 10)
- Plasma Concentrations of Baloxavir Marboxil - Extensive PK Population(Days 1 (Post-Dose), 2, 4, 6 and 10)
- Area Under the Concentration to Time Curve From Time 0 to Infinity (AUC0-inf) of S-033447.(Up to Day 10)
- Time to Maximum Plasma Concentration (Tmax) of Baloxavir Marboxil(Up to Day 10)
- Plasma Concentrations of Baloxavir Marboxil - Sparse PK Population(Days 1 (Post-Dose), 2, 4, 6 and 10)
- Time to Alleviation of Influenza Signs and Symptoms(Up to Day 15)
- Frequency of Influenza-Related Complications(Up to Day 29)
- Time to Cessation of Viral Shedding by Virus Titer(Day 1 - Day 29)
- Change From Baseline in Influenza Virus Titer at Day 2, 4, 6, 10, 15, 29(Baseline, Day 2, 3 (optional), 4, 6, 10, 15 (optional), 29)
- Change From Baseline in the Amount of Virus RNA (RT-PCR) at Day 2, 4, 6, 10, 15, 29(Baseline, Day 2, 3 (optional), 4, 6, 10, 15 (optional), 29)
- Duration of Fever(Up to Day 15)
- Duration of Symptoms(Up to Day 15)
- Time to Return to Normal Health and Activity(Up to Day 15)
- Percentage of Participants With Influenza-Related Complications(Up to Day 29)
- Time to Cessation of Viral Shedding by RT-PCR(Day 1 - Day 29)
- Percentage of Participants With Positive Influenza Virus Titer at Day 2, 4, 6, 10(Baseline, Day 2, 3 (optional), 4, 6, 10)
- Maximum Plasma Concentration (Cmax) of S-033447(Up to Day 10)
- Percentage of Participants Requiring Antibiotics(Up to Day 29)
- Percentage of Participants Positive by RT-PCR at Day 2, 4, 6, 10, 15, 29(Day 2, 3 (optional), 4, 6, 10, 15 (optional), 29)
- Area Under the Concentration to Time Curve From Time 0 to Infinity (AUC0-inf) of Baloxavir Marboxil(Up to Day 10)
- Maximum Plasma Concentration (Cmax) of Baloxavir Marboxil(Up to Day 10)
- Time to Maximum Plasma Concentration (Tmax) of S-033447(Up to Day 10)
- Plasma Concentrations of Baloxavir Marboxil by Dosage(24, 72, 96 and 240 hours post-dose)
- Area Under the Curve in Virus Titer(Day 1 - Day 29)
- Area Under the Curve in the Amount of Virus RNA (RT-PCR)(Day 1 - Day 10)
- Plasma Concentrations of S-033447 by Dosage(24, 72, 96 and 240 hours post-dose)