A Two Part Randomized Cross-Over Trial to Evaluate the Pharmacokinetics, Efficacy, and Safety Profile of Plasma Protein-Free Recombinant FVIII Formulated With Sucrose (BAY81-8973) in Previously Treated Subjects With Severe Hemophilia A Under Prophylaxis Therapy

Trial Profile

A Two Part Randomized Cross-Over Trial to Evaluate the Pharmacokinetics, Efficacy, and Safety Profile of Plasma Protein-Free Recombinant FVIII Formulated With Sucrose (BAY81-8973) in Previously Treated Subjects With Severe Hemophilia A Under Prophylaxis Therapy

Completed
Phase of Trial: Phase III

Latest Information Update: 06 Dec 2016

At a glance

  • Drugs Octocog alfa (Primary)
  • Indications Blood coagulation disorders; Haemophilia A
  • Focus Pharmacokinetics; Therapeutic Use
  • Acronyms LEOPOLD I
  • Sponsors Bayer
  • Most Recent Events

    • 07 Jun 2017 Biomarkers information updated
    • 06 Dec 2016 Results assessing rationale for investigator assigned prophylaxis dosing frequency presented at the 58th Annual Meeting and Exposition of the American Society of Hematology
    • 17 Mar 2016 According to a Bayer media release, Kovaltry has received regulatory approval in Canada.
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