A Phase 3 Study of CS-8958 (Prophylaxis of Single Administration)
- Conditions
- Postexposure prophylaxis of influenza A or B virus infection
- Registration Number
- JPRN-jRCT2080222628
- Lead Sponsor
- DAIICHI SANKYO CO., LTD.
- Brief Summary
Single dose of inhaled CS-8958 40 mg was effective as post-exposure prophylaxis to prevent the development of influenza through household contacts, as was the inhalation of 20 mg of CS-8958 once daily for 2 days. Adverse events in CS-8958 40 mg single-dose group did not differ significantly from those in the CS-8958 20 mg once daily for 2 days administration group and placebo-group. No abnormal behaviors were observed, and there were no other major safety issues.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 803
Household contact of a patient with influenza virus infection
Body temperature (axillary) at informed consent =< 36.9 degrees C
No influenza symptoms
Persons who are unable to cohabit with an index patient
Persons who cannot start study treatment within 48 hours after the initial onset of any influenza symptom in the index patient
Persons receiving corticosteroids or immunosuppressants
Persons who have a history of hypersensitivity to a neuraminidase inhibitor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method