A Phase II/III, Randomized, Cross-over, Open-label Trial to Demonstrate Superiority of Prophylaxis Over On-demand Therapy in Previously Treated Subjects With Severe Hemophilia A Treated With Plasma Protein-free Recombinant FVIII Formulated With Sucrose (BAY 81-8973)

Trial Profile

A Phase II/III, Randomized, Cross-over, Open-label Trial to Demonstrate Superiority of Prophylaxis Over On-demand Therapy in Previously Treated Subjects With Severe Hemophilia A Treated With Plasma Protein-free Recombinant FVIII Formulated With Sucrose (BAY 81-8973)

Completed
Phase of Trial: Phase II/III

Latest Information Update: 01 Mar 2017

At a glance

  • Drugs Octocog alfa (Primary)
  • Indications Haemophilia A
  • Focus Therapeutic Use
  • Acronyms LEOPOLD II
  • Sponsors Bayer
  • Most Recent Events

    • 17 Mar 2016 According to a Bayer media release, Kovaltry has received regulatory approval in Canada.
    • 17 Mar 2016 According to a Bayer media release, the US FDA has approved Kovaltry (Octocog-alfa) for the treatment of hemophilia A in children and adults.
    • 22 Feb 2016 According to a Bayer media release, the company received marketing approval from the European Commission for Kovaltry for the treatment of hemophilia A in patients with all age groups.
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