NCT03653364已完成3 期
A Multicenter, Single-Arm, Open-Label Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Otherwise Healthy Pediatric Patients From Birth to < 1 Year With Influenza-Like 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
- 49
- 试验地点
- 27
- 主要终点
- Number 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 in healthy pediatric participants from birth to <1 year with influenza like symptoms
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from birth to < 1 year at screening
- •Written informed consent for study participation obtained from participant's parents or legal guardian
- •Parent/guardian willing and able to comply with study requirements, in the investigator's judgment
- •Participants with a diagnosis of influenza virus infection confirmed by the presence of all of the following:
- •In the investigator's judgement there is a clinical suspicion of influenza
- •At least one respiratory symptom (either cough or coryza)
- •(b) Positive prescreening influenza test (RIDT or PCR) performed within 48 hours of screening
- •Participants with a negative prescreening COVID-19 test (RAT or PCR) within 48 hours of screening
- •The time interval between the onset of symptoms and screening is ≤ 96 hours (the onset of symptoms is defined as the time when body temperature first exceeded 37.5°C if known, or the time when the first symptom was noticed by the parent or caregiver)
排除标准
- •Hospitalized for complications of influenza or significant comorbidities
- •Concurrent infections requiring systemic antiviral therapy at screening
- •Require, in the opinion of the investigator, any of the prohibited medication during the study
- •Preterm neonates (born at < 37 weeks gestation) and/or weighing < 2.5 kg at screening
- •Previous treatment with peramivir, laninamivir, oseltamivir, zanamivir, or amantadine within 2 weeks prior to screening
- •Immunization with a live/attenuated influenza vaccine during the 2 weeks prior to screening
- •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 transplant
- •Known hypersensitivity to study drug (i.e., baloxavir marboxil) or to acetaminophen
- •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
Experimental
Participants will receive single oral dose of baloxavir marboxil on Day 1 (based on body weight and age).
干预措施: Baloxavir Marboxil (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: From Day 1 up to Day 29
An 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 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 Baloxavir Marboxil and S-033447(0.5 to 2 hours post dose on Day 1; 24 hours (Day 2) and 72 hours (Day 4) post dose, Day 6 and Day 10)
- Time to Maximum Plasma Concentration (Tmax) of Baloxavir Marboxil and S-033447(Up to Day 10)
- Duration of Symptoms(Day 1 up to Day 15)
- Time to Cessation of Viral Shedding by Virus Titer(Day 1 up to Day 29)
- Time to Cessation of Viral Shedding by Reverse Transcription-Polymerase Chain Reaction (RT-PCR)(Day 1 up to Day 29)
- Time to Return to Normal Health and Activity(Day 1 up to Day 15)
- Number of Participants Requiring Antibiotics(Day 1 up to Day 29)
- Change From Baseline in the Amount of Virus RNA (RT-PCR) Over Time(Baseline, Days 2, 4, 6, and 10)
- Percentage of Participants With Positive Influenza Virus Titer Over Time(Baseline, Days 2, 4, 6, 10, and 29)
- Percentage of Participants Positive by RT-PCR Over Time(Baseline, Days 2, 4, 6, 10, and 29)
- Area Under the Concentration-Time Curve (AUC) in Virus Titer(Day 1 up to Day 29)
- Area Under the Curve in the Amount of Virus RNA (RT-PCR)(Day 1 up to Day 29)
- Area Under the Concentration to Time Curve From Time 0 to Infinity (AUC0-inf) of Baloxavir Marboxil and S-033447(Up to Day 10)
- Maximum Plasma Concentration (Cmax) of Baloxavir Marboxil and S-033447(Up to Day 10)
- Apparent Half-Life (T1/2) of Baloxavir Marboxil and S-033447(Up to Day 10)
- Time to Alleviation of Influenza Signs and Symptoms(Day 1 up to Day 15)
- Duration of Fever(Day 1 up to Day 15)
- Number of Participants With Influenza-Related Complications(Day 1 up to Day 29)
- Change From Baseline in Influenza Virus Titer Over Time(Baseline, Days 2, 4, 6, 10, and 29)
研究者
研究点 (27)
Loading locations...
相似试验
已完成
3 期
Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants With Influenza-Like SymptomsInfluenzaNCT03629184Hoffmann-La Roche173
已完成
3 期
Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Chinese Pediatric Participants 1 to <12 Years of Age With Influenza SymptomsInfluenzaNCT06774859Hoffmann-La Roche100
已完成
3 期
A Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Otherwise Healthy Patients With InfluenzaInfluenzaNCT02954354Shionogi1,436
已完成
3 期
Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Patients With Influenza at High Risk of Influenza ComplicationsInfluenzaNCT02949011Shionogi2,184
已完成
3 期
Study to Assess Efficacy and Safety of Baloxavir Marboxil In Combination With Standard-of-Care Neuraminidase Inhibitor In Hospitalized Participants With Severe InfluenzaInfluenzaNCT03684044Hoffmann-La Roche363