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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)

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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)

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 13 Jan 2023

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At a glance

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

Most Recent Events

  • 01 Jan 2023 Results assessing BAY 81-8973 efficacy and safety when used for bleed prophylaxis and treatment in previously untreated/minimally treated patients in LEOPOLD trials, published in the Thrombosis and Haemostasis.
  • 06 Nov 2019 Results of integrated regression analysis of (NCT01184820, NCT01029340, NCT00623727, NCT01233258, NCT02483208, and NCT01580293) assessing correlations between von Willebrand Factor Antigen Levels and Factor VIII Pharmacokinetics Are Similar across Different FVIII Products in Patients with Severe Hemophilia A released at the 61st 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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