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
- jRCT2080224512
- Lead Sponsor
- SHIONOGI & CO., LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 30
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
- Open-label, non-controlled
- Primary Outcome Measures
Name Time Method - safety
Percentage of patients with any adverse events, etc.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Japan
Location not specified
Japan