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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

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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

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 13 Jan 2022

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At a glance

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

Most Recent Events

  • 12 Jan 2022 This trial has been completed in Romania (Date of the global end of the trial : 08-Jan-2021), according to European Clinical Trials Database record.
  • 28 May 2019 This trial has been completed in Croatia, according to European Clinical Trials Database.
  • 20 Feb 2019 This trial has been completed in Hungary, according to European Clinical Trials Database.

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