A Phase IIIB, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Clinical Efficacy Study of Baloxavir Marboxil for the Reduction of Direct Transmission of Influenza From Otherwise Healthy Patients to Household Contacts

F. Hoffmann-La Roche, Ltd.1 个研究点目标入组 320 人开始时间: 待定最近更新: 2024年7月3日

试验速览

阶段: 3 期
状态: 已完成
发起方: F. Hoffmann-La Roche, Ltd.
入组人数: 320
试验地点: 1
主要终点: Percentage of Household Contacts (HHCs) who become Polymerase Chain Reaction Positive (PCR+) for Influenza by Day 5 Post IP Randomization

暂无简介。

•Index Patients (IPs):
•Diagnosed with acute influenza infection by investigator.
•Polymerase chain reaction [PCR] (+) or Rapid Influenza Diagnostic Test [RIDT] (+) for influenza A/B based on cobas influenza A/B Assay or other point-of-care / local laboratory results.
•Presence of (a) fever (>=38.0 degrees Celsius per tympanic or rectal thermometer; >=37.5 degrees Celsius per axillary, oral or forehead/temporal thermometer) or (b) any influenza symptoms (cough, sore throat, nasal congestion, headache, feverishness or chills, muscle or joint pain, fatigue).
•The time interval between the onset of fever or influenza symptoms and the pre-dose examinations is 48 hours or less. etc,
•PCR (-) or RIDT (-) based on cobas influenza A/B Assay or other local point-of-care / local laboratory result at Day 0 Visit. etc,
•HHC intended for full study must meet the following additional criteria for study entry:
•No influenza symptoms within 7 days prior to screening. Alternatively, mild symptoms are permissible if determined by the investigator to be due to a pre-existing condition.
•Temperature <38.0 degrees Celsius (tympanic).
•Will reside in the index patient's house for at least 7 of the next 9 days and will be present for scheduled study visits.

•IPs with severe influenza virus infection requiring inpatient treatment.
•IPs judged by the investigator to be at high risk for complications of influenza.
•IPs weighing less than 40 kg.
•Known hypersensitivity to baloxavir marboxil or the drug product excipients. etc,
•Pregnant or within 2 weeks post-partum at screening.
•Immunocompromised.
•Less than 2 years old. etc,

Percentage of Household Contacts (HHCs) who become Polymerase Chain Reaction Positive (PCR+) for Influenza by Day 5 Post IP Randomization

时间窗: Baseline to Day 5 (5 days)

Percentage of Household Contacts (HHCs) who become Polymerase Chain Reaction Positive (PCR+) for Influenza

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发起方

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