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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Jan 2023

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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

  • 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.
  • 08 Dec 2020 Results evaluating the efficacy and safety outcomes of patients with hemophilia A who were receiving FVIII-FS prior to enrolling into the LEOPOLD I and LEOPOLD KIDS clinical studies, presented at the 62nd Annual Meeting and Exposition of the American Society of Hematology.
  • 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

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