Takeda Announces Results from First-of-Its-Kind Phase IIIb/IV Trial PROPEL – a Randomized PK-Guided Prophylaxis Study Evaluating Higher Factor VIII Levels in Hemophilia A– at EAHAD 2019 - Seite 2

In addition to PROPEL, Takeda will present a dozen scientific data releases on the company’s recently acquired broad portfolio of treatments for bleeding disorders throughout EAHAD, including:

• AHEAD international and German studies: Effectiveness, safety, and quality of life outcomes in hemophilia A patients treated with antihemophilic factor (recombinant) in a real world setting over 5 years.
• Insights into the evolution of haemophiliac arthropathy: The Irish personalised approach to the treatment of haemophilia (iPATH) study.
• Physical activity and haemophilic joint arthropathy amongst adults with severe haemophilia in Ireland: The Irish personalised approach to the treatment of haemophilia (iPATH) study.
• Barriers to physical activity amongst adults with moderate and severe haemophilia in Ireland: The Irish personalised approach to the treatment of haemophilia (iPATH) study.
• Results from a phase 3B, open-label, multicenter, continuation study of rurioctocog alfa pegol for prophylaxis in previously treated patients with severe hemophilia A: Analysis by age group.
• Design of a phase 3, prospective, multicenter, open-label study of safety and hemostatic efficacy of rurioctocog alfa pegol in previously untreated patients <6 years of age with severe hemophilia A.
• Demographic and baseline data from patients with hemophilia and inhibitors enrolled in the FEIBA global outcomes (“FEIBA GO”) study.
• Analysis of joint bleeding events from a phase 3, multicenter, open-label study of on-demand recombinant von Willebrand factor (VWF) treatment in patients with severe von Willebrand disease (VWD).
• Evaluation of laboratory safety data from patients with severe von Willebrand disease (VWD) in association with infusion of recombinant von Willebrand factor (VWF) in a phase 3, multicenter, open-label study.
• Efficacy and safety of prophylaxis with recombinant von Willebrand factor (VWF) in severe von Willebrand disease (VWD): Design of a prospective, phase 3, open-label, international multicenter study.
• Nonclinical safety evaluation of a next generation factor IX (FIX) gene therapy construct (SHP648) in mice.

About the PROPEL Study