Study to confirm the efficacy of baloxavir marboxil versus placebo in the prevention of influenza virus infection
Phase 3
Completed
- Conditions
- Influenza A and/or B virus infection
- Registration Number
- jRCT2080224119
- Lead Sponsor
- Shionogi & Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 750
Inclusion Criteria
-Subjects who had lived with the patients with influenza virus infection for 48 hours or more prior to informed consent.
-Subjects who are judged not to have influenza virus infection by the investigator.
etc.
Exclusion Criteria
-Subjects who are unable to live with the index patient from Screening until Day 10. -Subjects who have any underlying diseases requiring systemic (oral or injection), or nasal treatment of antipyretics/analgesics, corticosteroids, or immunosuppressive agents. etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Multicenter, randomized, double-blind, parallel-group
- Primary Outcome Measures
Name Time Method Proportion of subjects who are infected with influenza virus (RT-PCR positive), and present with fever and at least one respiratory symptom Day 1 to Day 10 Proportion of subjects who are infected with influenza virus (RT-PCR positive), and present with fever and at least one respiratory symptom
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Japan
Location not specified
Japan