A Open-label Study of Baloxavir Marboxil Granules in Otherwise Healthy Pediatric Patients With Influenza

An Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of Baloxavir Marboxil 2% Granules after Administration of a Single Dose to Otherwise Healthy Pediatric Patients with Influenza

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224512

Enrollment

Registered

2019-01-11

Start date

2019-01-21

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: - Patients confirmed with influenza virus infection and within 48 hours from onset. - Patients whose body weight is less than 20 kg. etc.

Exclusion criteria

Exclusion criteria: -Patients with severe symptoms of influenza virus infection requiring inpatient treatment. - Patients with high risk factors. - Patients with concurrent infections requiring systemic antimicrobial and/or antiviral therapy. etc.

Design outcomes

Primary

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

Secondary

Measure	Time frame
efficacy pharmacokinetics time to alleviation of influenza illness, etc.	—

Countries

Japan

Outcome results

None listed

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