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A Phase 1, Open-label, Single-dose, Parallel-group Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of Pimodivir in Adult Subjects

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Trial Profile

A Phase 1, Open-label, Single-dose, Parallel-group Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of Pimodivir in Adult Subjects

Status: Discontinued
Phase of Trial: Phase I

Latest Information Update: 05 Jun 2021

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At a glance

  • Drugs Pimodivir (Primary)
  • Indications Influenza A virus infections
  • Focus Pharmacokinetics
  • Sponsors Janssen-Cilag

Most Recent Events

  • 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.
  • 02 Sep 2020 Status changed from recruiting to discontinued, according to a Janssen media release.
  • 04 Aug 2020 Planned End Date changed from 28 Jul 2020 to 30 Nov 2020.

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