NCT06774859已完成3 期
A Phase III, Randomized, Open-Label, Active-Controlled Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Chinese Pediatric Patients 1 to <12 Years of Age With Influenza Symptoms
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 18
- 主要终点
- Number of Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety of a single dose baloxavir marboxil compared with 5 days of oseltamivir administered twice a day (BID) in Chinese pediatric participants aged 1 to < 12 years with influenza 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
- None
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
- •A participant who has a diagnosis of influenza virus infection and meets all the following conditions:
- •Fever ≥ 38°C (tympanic temperature) at screening
- •At least one of the respiratory symptoms of influenza virus infection
- •A rapid influenza diagnostic test (RIDT) or polymerase chain reaction (PCR) shows positive for influenza A/B, e.g., point-of-care/local laboratory results with use of nasal aspirate, throat swab, or nasal drip/droplet (or other appropriate sample)
- •The time interval between the onset of symptoms and screening is ≤ 48 hours
- •PCR (-) or antigen test (-) for severe acute respiratory virus-coronavirus 2 (SARS-CoV-2) using point-of-care/local laboratory test with nasal aspirate, throat swab, or nasal drip/droplet (or other appropriate sample)
排除标准
- •A participant having severe influenza virus infection symptoms requiring inpatient treatment
- •Received systemic corticosteroid or immunosuppressive therapy
- •Primary immunodeficiency syndrome
- •History of organ transplantation
- •Human immunodeficiency virus (HIV) infection
- •Immunization with a live/attenuated influenza vaccine in 2 weeks prior to randomization
- •Previous malignancy within the last 5 years or has an active cancer at any site
- •A participant who received any medications with anti-flu effect such as baloxavir, peramivir, oseltamivir, zanamivir, favipiravir, arbidol, amantadine or traditional Chinese anti-influenza medicines within 30 days before screening
- •Diagnosed with or suspected SARS-CoV-2 infection, or close contacts of diagnosed or suspected SARS-CoV-2 infected patients
- •Severe underlying disease or condition potentially affecting study evaluation in the opinion of the investigator/sub-investigator
- •A participant who received an investigational or unapproved drug product within 30 days or 5 x the half-life before screening, whichever is longer
研究组 & 干预措施
Baloxavir Marboxil
Experimental
Participants will receive a single oral dose of baloxavir marboxil on Day 1 based on body weight.
干预措施: Baloxavir Marboxil (Drug)
Oseltamivir
Active Comparator
Participants will receive oseltamivir twice a day for 5 days based on body weight.
干预措施: Oseltamivir (Drug)
结局指标
主要结局
Number of Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Up to Day 29
次要结局
- Change From Baseline in the Amount of Virus RNA (Based on RT-PCR)(Baseline (Day 1), Day 2, 4, 6, 10, 15 and 29)
- Percentage of Participants With Positive Influenza Virus Titer(Day 2, 4, 6, 10, 15 and 29)
- Percentage of Participants With Positive for Influenza Virus as Assessed by RT-PCR(Day 2, 4, 6, 10, 15 and 29)
- Area Under the Curve in Amount of Virus RNA (Based on RT-PCR)(Day 1 to Day 29)
- Area Under the Curve (AUC) in Virus Titer(Day 1 to Day 29)
- Plasma Concentrations of S-033447(Up to 72 hours post dose)
- Area Under the Concentration-time Curve Extrapolated to Infinity (AUCinf) of S-033447(Up to Day 10)
- Maximum Observed Concentration (Cmax) of S-033447(Up to Day 10)
- Elimination Half-life (t1/2) of S-033447(Up to Day 10)
- Time of Maximum Observed Concentration (Tmax) of S-033447(Up to Day 10)
- Effective Concentration (EC50) of Baloxavir Marboxil Evaluated by ViroSpot™ Assay(Up to Day 29)
- Percentage of Participants with Responses to Palatability and Acceptability Questionnaire(Day 1)
- Time to Alleviation of Influenza Signs and Symptoms(Up to Day 15)
- Duration of Fever(Up to Day 15)
- Duration of Symptoms(Up to Day 15)
- Time to Return to Normal Health and Activity Based on the CARIFS Questionnaire(Up to Day 15)
- Frequency of Influenza-Related Complications(Up to Day 29)
- Percentage of Participants Requiring Antibiotics for Influenza Related Complications(Up to Day 29)
- Time to Cessation of Viral Shedding as Assessed by Virus Titer(Day 1 to Day 29)
- Time to Cessation of Viral Shedding as Assessed by Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)(Day 1 to Day 29)
- Change From Baseline in Influenza Virus Titer(Baseline (Day 1), Day 2, 4, 6, 10, 15 and 29)
- Polymorphic and Treatment-emergent Amino Acid Substitutions in the PA Gene(Baseline (Day 1) up to Day 29)
研究者
研究点 (18)
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