Study to confirm the efficacy of baloxavir marboxil versus placebo in the prevention of influenza virus infectio

Phase 3

Completed

• Conditions: Influenza A and/or B virus infection

• Registration Number: JPRN-jRCT2080224119
• Lead Sponsor: Shionogi & Co., Ltd.

Brief Summary

The efficacy of baloxavir marboxil was demonstrated compared with placebo in the prevention of influenza virus infection in subjects who were household members of influenza-infected patients. A single oral dose of baloxavir marboxil for the prevention of influenza virus infection was well tolerated.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-30
• Study Completion: 2019-03-25
• Results First Posted: 2020-07-08
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 752

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: Not specified