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A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-Care Treatment in Adolescent, Adult, and Elderly Hospitalized Patients With Influenza A Infection

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Trial Profile

A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-Care Treatment in Adolescent, Adult, and Elderly Hospitalized Patients With Influenza A Infection

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 05 Nov 2021

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At a glance

  • Drugs Pimodivir (Primary) ; Antivirals
  • Indications Influenza A virus infections
  • Focus Registrational; Therapeutic Use
  • Acronyms SAPPHIRE
  • Sponsors Janssen Research & Development; Janssen-Cilag
  • Most Recent Events

    • 09 Oct 2020 This trial has been completed in the United Kingdom according to European Clinical Trials Database record.
    • 13 Sep 2020 This trial has been completed in Belgium according to European Clinical Trials Database record.
    • 02 Sep 2020 According to a Janssen media release, company discontinued development of pimodivir for the treatment of influenza A infection. This decision is based on results from pre-planned interim analyses of the pimodivir phase III trial in hospitalized patients with influenza A. Pimodivir in combination with the standard of care (SOC) fails to demonstrate added benefit in hospitalized patients with influenza A compared to SOC treatment alone.
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