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

Completed
Phase of Trial: Phase II

Latest Information Update: 08 Sep 2017

At a glance

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

    • 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).
    • 01 Jun 2017 This trial has been completed in Hungary (End date:2017-04-03) as per European Clinical Trials Database record.
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