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: 12 Dec 2017

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

    • 12 Dec 2017 Results of post-hoc analysis assessing the association of BAY 81-8973 prophylaxis frequency with treatment adherence and long-term bleed outcomes in the main and extension periods of LEOPOLD I study, presented at the 59th Annual Meeting and Exposition of the American Society of Hematology.
    • 10 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
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