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A Multi-center, Phase III, Non-controlled, Open-label Trial to Evaluate the Pharmacokinetics, Safety, and Efficacy of BAY94-9027 for Prophylaxis and Treatment of Bleeding in Previously Treated Children (Age less than 12 Years) With Severe Hemophilia A

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Trial Profile

A Multi-center, Phase III, Non-controlled, Open-label Trial to Evaluate the Pharmacokinetics, Safety, and Efficacy of BAY94-9027 for Prophylaxis and Treatment of Bleeding in Previously Treated Children (Age less than 12 Years) With Severe Hemophilia A

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 30 Aug 2021

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At a glance

  • Drugs Damoctocog alfa pegol (Primary)
  • Indications Haemophilia A
  • Focus Pharmacodynamics; Pharmacokinetics; Registrational; Therapeutic Use
  • Acronyms PROTECT KIDS; PROTECT VIII Kids
  • Sponsors Bayer

    • Most Recent Events

    • 08 Dec 2020 Long-term safety and efficacy data (n=59) presented at the 62nd Annual Meeting and Exposition of the American Society of Hematology.
    • 10 Mar 2020 Status changed from active, no longer recruiting to completed.
    • 04 Mar 2020 This trial has been completed in Bulgaria, according to European Clinical Database record.

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