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A Phase III, Randomized, Double-Blind Placebo-Controlled, Multicenter Study To Evaluate the Efficacy and Safety of Baloxavir Marboxil in Combination With Standard-of-Care Neuraminidase Inhibitor in Hospitalized Participants With Severe Influenza

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Trial Profile

A Phase III, Randomized, Double-Blind Placebo-Controlled, Multicenter Study To Evaluate the Efficacy and Safety of Baloxavir Marboxil in Combination With Standard-of-Care Neuraminidase Inhibitor in Hospitalized Participants With Severe Influenza

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 07 Dec 2019

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At a glance

  • Drugs Baloxavir-marboxil (Primary) ; Oseltamivir; Peramivir; Zanamivir
  • Indications Influenza A virus infections; Influenza B virus infections
  • Focus Registrational; Therapeutic Use
  • Sponsors Roche

    • Most Recent Events

    • 08 Nov 2019 Planned End Date changed from 10 Jul 2021 to 27 Mar 2021.
    • 08 Nov 2019 Planned primary completion date changed from 10 Jul 2021 to 27 Mar 2021.
    • 23 Jul 2019 Planned number of patients changed from 240 to 366.
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