Study to Assess the Pharmacokinetics, Safety and Tolerability of Baloxavir Marboxil in Healthy Chinese Participants
Completed
Shionogi
N/A
2019-06-19
This study will evaluate the pharmacokinetics, safety and tolerability of a single oral dose
of baloxavir marboxil (40 mg or 80 mg) in healthy Chinese participants.
Study to Assess the Pharmacokinetics, Safety and Tolerability of Baloxavir Marboxil in Healthy Chinese Participants
Completed
Hoffmann-La Roche
N/A
2019-06-19
This study will evaluate the pharmacokinetics, safety and tolerability of a single oral dose
of baloxavir marboxil (40 mg or 80 mg) in healthy Chinese participants.
Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Households
Recruiting
Hoffmann-La Roche
Phase 3
2019-10-10
Otherwise healthy index patients (IP) are randomized to either baloxavir marboxil or placebo
if their influenza symptoms onset was within 48 hours of screening. Their households are
enrolled within 24 hours of randomization if at least 2 household contacts (HHC) have not
received influenza vaccine within 6 months of screening and if all HHC screen negative for
influenza infection. The main endpoints are assessed based on multiple respiratory swabs,
obtained from both IP and HHC up to 9 (+/-1) days post IP randomization, and through the
assessment of symptoms.
Pilot of Cohort of Households for Influenza Monitoring and Evaluation in Seattle
Completed
Genentech, Inc.
Phase 4
2019-11-01
This study will evaluate a home-based approach to influenza infection control, using
prepositioned home-based influenza self-test kits, telemedicine services, and rapid delivery
of Xofluza (Baloxavir marboxil) for administration within 48 hours of symptom onset.
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