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An Open Label, Prospective, Pharmacokinetic/Pharmacodynamic and Safety Evaluation of Oseltamivir (Tamiflu) in the Treatment of Infants 0 to less than 12 Months of Age With Confirmed Influenza Infection

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Trial Profile

An Open Label, Prospective, Pharmacokinetic/Pharmacodynamic and Safety Evaluation of Oseltamivir (Tamiflu) in the Treatment of Infants 0 to less than 12 Months of Age With Confirmed Influenza Infection

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 07 Apr 2022

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At a glance

  • Drugs Oseltamivir (Primary)
  • Indications Influenza virus infections
  • Focus Pharmacokinetics; Registrational
  • Sponsors Roche

    • Most Recent Events

    • 21 Dec 2012 The US FDA extended the approval of oseltamivir to include infants 2 weeks of age and older, based on this and another study, according to a Genentech media release.
    • 01 Jul 2012 Status changed from recruiting to completed as reported by ClinicalTrials.gov.
    • 17 Mar 2012 Planned number of patients changed from 84 to 85 as reported by European Clinical Trials Database.
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