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

A phase 3 randomized, double-blind, placebo-controlled study to confirm the efficacy of a single dose of baloxavir marboxil in the prevention of influenza virus infection

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224119

Enrollment

750

Registered

2018-10-30

Start date

2018-11-09

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza A and/or B virus infection

Interventions

investigational material(s) Generic name etc : baloxavir marboxil INN of investigational material : baloxavir marboxil Therapeutic category code : 625 Anti-virus agents Dosage and Administration for I

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
efficacy Proportion of subjects who are infected with influenza virus (RT-PCR positive), and present with fever and at least one respiratory symptom in the period from Day 1 to Day 10	—

Secondary

Measure	Time frame
safety efficacy pharmacokinetics Percentage of patients with any adverse events, etc.	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026