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.0 个研究点目标入组 320 人开始时间: 2019年9月27日最近更新: 2023年10月17日

试验速览

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•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,

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