Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Patients With Influenza at High Risk of Influenza Complications
Completed
Shionogi
Phase 3
2017-01-11
The primary objective of this study is to evaluate the efficacy of a single, oral dose of
baloxavir marboxil compared with placebo by measuring the time to improvement of influenza
symptoms in patients with influenza presenting within 48 hours of symptom onset.
A Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Otherwise Healthy Patients With Influenza
Completed
Shionogi
Phase 3
2016-12-08
The primary objective of this study is to evaluate the efficacy of a single, oral dose of
baloxavir marboxil compared with placebo by measuring the time to alleviation of symptoms in
patients with uncomplicated influenza virus infection.
Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants With Influenza-Like Symptoms
Completed
Hoffmann-La Roche
Phase 3
2018-11-20
This study will evaluate the safety, pharmacokinetics, and efficacy of baloxavir marboxil
compared with oseltamivir in a single influenza episode in otherwise healthy pediatric
participants (i.e., 1 to <12 years of age) with influenza-like symptoms.
Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants From Birth to < 1 Year With Influenza-Like Symptoms
Recruiting
Hoffmann-La Roche
Phase 3
2019-01-23
This study will evaluate the safety, pharmacokinetics and efficacy of baloxavir marboxil in
healthy pediatric participants from birth to <1 year with influenza like symptoms
Study to Assess Efficacy and Safety of Baloxavir Marboxil In Combination With Standard-of-Care Neuraminidase Inhibitor In Hospitalized Participants With Severe Influenza
Completed
Hoffmann-La Roche
Phase 3
2019-01-08
This study will evaluate the efficacy, safety, and pharmacokinetics of baloxavir marboxil in
combination with a standard-of-care (SOC) neuraminidase inhibitor (NAI) (i.e., oseltamivir,
zanamivir, or peramivir) compared with a matching placebo in combination with a SOC NAI in
hospitalized patients with influenza.
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