An Open-Label, Randomized, Active-Controlled, Multicenter Study to Evaluate the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Lipegfilgrastim 100 μg/kg Body Weight in Comparison to Filgrastim 5 μg/kg Body Weight in Pediatric Patients Diagnosed with Ewing Family of Tumors or Rhabdomyosarcoma Receiving Chemotherapy

Trial Profile

An Open-Label, Randomized, Active-Controlled, Multicenter Study to Evaluate the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Lipegfilgrastim 100 μg/kg Body Weight in Comparison to Filgrastim 5 μg/kg Body Weight in Pediatric Patients Diagnosed with Ewing Family of Tumors or Rhabdomyosarcoma Receiving Chemotherapy

Recruiting
Phase of Trial: Phase II

Latest Information Update: 11 Aug 2017

At a glance

  • Drugs Lipegfilgrastim (Primary) ; Filgrastim
  • Indications Neutropenia
  • Focus Therapeutic Use
  • Sponsors Merckle
  • Most Recent Events

    • 10 Jun 2017 This trial has been suspended in Spain.
    • 18 Jun 2015 New trial record
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