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A Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Efficacy, and Immunogenicity of Daily Subcutaneous Administration of 5 mug/kg Tbo-filgrastim in Infants, Children and Adolescents With Solid Tumors Without Bone Marrow Involvement

Trial Profile

A Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Efficacy, and Immunogenicity of Daily Subcutaneous Administration of 5 mug/kg Tbo-filgrastim in Infants, Children and Adolescents With Solid Tumors Without Bone Marrow Involvement

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 26 Sep 2018

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At a glance

  • Drugs Filgrastim (Primary)
  • Indications Neutropenia
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Teva Pharmaceutical Industries
  • Most Recent Events

    • 12 Dec 2017 Results presented at the 59th Annual Meeting and Exposition of the American Society of Hematology
    • 01 Sep 2017 Status changed from active, no longer recruiting to completed.
    • 15 Jun 2017 This trial has been completed in Bulgaria (end date: 3 Apr 2017) and Croatia (end date: 3 Apr 2017).
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