Study to assess efficacy and safety of baloxavir marboxil in combination with standard-of-care neuraminidase inhibitor in hospitalized Patients with severe influenza
- Conditions
- Influenza A and/or B virus infection
- Registration Number
- JPRN-jRCT2080224144
- Lead Sponsor
- F. Hoffmann-La Roche, Ltd.
- Brief Summary
The study did not meet its primary efficacy endpoint. The results of the key secondary and other secondary efficacy endpoints were consistent with those of the primary endpoint; although the results generally showed numerical improvements in favor of the baloxavir marboxil group, no differences between the two treatment groups were identified in the exploratory statistical tests. Baloxavir marboxil was well tolerated, and no new safety signals or adverse drug reactions were identified.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 366
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.
- Known contraindication to neuraminidase inhibitors.
- Patients with known severe renal impairment or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis.
etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Time to Clinical Improvement [Time Frame: Up to Day 35]<br>Time to Clinical Improvement is defined as:<br>- Time to Hospital Discharge OR<br>- Time to NEWS2 (National Early Warning Score 2) of 2 or lower maintained for 24 hours
- Secondary Outcome Measures
Name Time Method efficacy<br>pharmacokinetics<br>safety<br>- Response Rates of the 6-Point Ordinal Scale at Day 7 [ Time Frame: Day 7 ]<br>- Percentage of Patients with Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: Up to Day 35]<br>- Plasma Concentration of Baloxavir (Active Metabolite) at Specified Time Points, etc.