NCT07827599尚未招募3 期
A Phase III, Randomized, Double-blinded, Placebo-controlled Study to Confirm Efficacy of a Single Dose of Baloxavir Marboxil in the Post-exposure Prophylaxis of Influenza Virus Infection in Chinese Participants
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 325
- 主要终点
- Percentage of Participants who are Infected With Influenza Virus (Reverse Transcription - Polymerase Chain Reaction [RT-PCR] Positive), and Present With Fever and at Least one Respiratory Symptom
研究概览
简要总结
The main purpose of the study is to evaluate the efficacy of a single dose of baloxavir marboxil compared with placebo in the PEP of influenza virus infection with respect to symptomatic, laboratory-confirmed influenza in participants who are household contacts (HHCs) of participants with influenza (index participants).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
The sponsor and its agents will also be blinded to treatment assignment.
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Index Participants (Participants With Influenza Virus Infection):
- •First participant in a household with influenza virus infection in the current influenza season
- •Fewer than 6 HHCs
- •Agreement by all household members to participate in the study and comply with the study protocol for the duration of the study
- •Diagnosed as having influenza with positive rapid influenza diagnostic test (RIDT) or polymerase chain reaction (PCR) result
- •Onset of symptoms within 48 hours or less at time of signing Informed Consent Form (ICF)/Assent Form
- •PCR (-) or antigen test (-) for severe acute respiratory virus-coronavirus 2 (SARS-CoV-2) using point-of-care or local laboratory test
- •HHCs of Index Participants:
- •Lived with the index participant for 48 hours or more prior to informed consent/assent
- •Meet all the following criteria and are judged not to have influenza virus infection by the investigator: body temperature (tympanic) <37.5 degrees Celsius (°C); no influenza-like symptoms (cough, sore throat, headache, nasal discharge/nasal congestion, feverishness or chills, muscle or joint pain, or fatigue) at screening; negative RIDT or PCR result for influenza
- •For participants 12 years of age or older, ability to evaluate influenza symptoms by using a participant influenza symptoms diary; For participants under 12 years of age, capability of parents/caregivers to evaluate influenza symptoms by using a participant influenza symptoms diary
- •PCR (-) or antigen test (-) for SARS-CoV-2 using point-of-care or local laboratory test
排除标准
- •HHCs of Index Participants:
- •Diagnosed with influenza during the current influenza season
- •Unable to live with the index patient from screening until Day 10
- •Live with a household member who has any influenza-like symptom(s) other than the index participant on the day of screening
- •Live with household members other than the index participant who was diagnosed with or strongly suspected to have influenza during the current influenza season
- •Have any underlying diseases requiring systemic (oral or injection), or nasal treatment of antipyretics/analgesics, corticosteroids, or immunosuppressive agents
- •Immunocompromised
- •Use of any medications with anti-influenza effect within 30 days prior to screening
- •Known allergy and/or history of significant intolerance against baloxavir marboxil
- •Exposure to an investigational drug within 30 days or 5 half-lives of the drug prior to screening, whichever is longer
- •Note: Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Placebo
Placebo Comparator
HHCs will receive baloxavir marboxil matching placebo according to their body weight as outlined in the protocol.
干预措施: Placebo (Drug)
No Intervention
No Intervention
Index participants will not receive any study treatment but will continue to receive SOC treatment for influenza, as per the local guidelines.
Baloxavir Marboxil
Experimental
HHCs will receive baloxavir marboxil according to their body weight as outlined in the protocol.
干预措施: Baloxavir marboxil (Drug)
结局指标
主要结局
Percentage of Participants who are Infected With Influenza Virus (Reverse Transcription - Polymerase Chain Reaction [RT-PCR] Positive), and Present With Fever and at Least one Respiratory Symptom
时间窗: From Day 1 up to Day 10
次要结局
- Percentage of Participants who are Infected With Influenza Virus (RT-PCR Positive), and Present With Fever or at Least one Influenza Symptom (Respiratory or Systemic)(From Day 1 up to Day 10)
- Percentage of Participants who are Infected With Influenza Virus (RT-PCR Positive) Regardless of Body Temperature or Influenza Symptoms(From Day 1 up to Day 10)
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(Up to Day 21)
研究者
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