Study to assess efficacy and safety of baloxavir marboxil in combination with standard-of-care neuraminidase inhibitor in hospitalized Patients with severe influenza

A Phase III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of baloxavir marboxil in combination with standard-of-care neuraminidase inhibitor in hospitalized patients with severe influenza

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224144

Enrollment

Registered

2018-11-15

Start date

2019-01-08

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 who require hospitalization for severe influenza or acquire influenza during hospitalization, the severity of which requires an extension of hospitalization. - The time interval between the onset of symptoms and randomization is within 96 hours. etc.

Exclusion criteria

Exclusion criteria: - Known contraindication to neuraminidase inhibitors. - Patients with known severe renal impairment or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis. etc.

Design outcomes

Primary

Measure	Time frame
efficacy Time to Clinical Improvement [Time Frame: Up to Day 35] Time to Clinical Improvement is defined as: - Time to Hospital Discharge OR - Time to NEWS2 (National Early Warning Score 2) of 2 or lower maintained for 24 hours	—

Secondary

Measure	Time frame
efficacy pharmacokinetics safety - Response Rates of the 6-Point Ordinal Scale at Day 7 [ Time Frame: Day 7 ] - Percentage of Patients with Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: Up to Day 35] - Plasma Concentration of Baloxavir (Active Metabolite) at Specified Time Points, etc.	—

Countries

Asia except Japan, Europe, Japan, North America, Oceania, South America

Outcome results

None listed

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