A Open-label Study of Baloxavir Marboxil Granules in Otherwise Healthy Pediatric Patients With Influenza
Phase 3
Completed
- Conditions
- Influenza A and/or B virus infection
- Registration Number
- JPRN-jRCT2080224512
- Lead Sponsor
- SHIONOGI & CO., LTD.
- Brief Summary
S-033188 2% granules were considered to be well tolerated and effective in pediatric patients with influenza virus infection who weighed less than 20 kg at higher doses than those administered in the previous studies in Japanese pediatric patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 45
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
-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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>Percentage of patients with any adverse events, etc.
- Secondary Outcome Measures
Name Time Method efficacy<br>pharmacokinetics<br>time to alleviation of influenza illness, etc.