A Phase II/III, Multicenter, Partially Randomized, Open Label Trial Investigating Safety and Efficacy of On-demand and Prophylactic Treatment With BAY94-9027 in Severe Hemophilia A

Trial Profile

A Phase II/III, Multicenter, Partially Randomized, Open Label Trial Investigating Safety and Efficacy of On-demand and Prophylactic Treatment With BAY94-9027 in Severe Hemophilia A

Active, no longer recruiting
Phase of Trial: Phase II/III

Latest Information Update: 14 Nov 2017

At a glance

  • Drugs Damoctocog alfa pegol (Primary)
  • Indications Haemophilia A
  • Focus Pharmacokinetics; Therapeutic Use
  • Acronyms PROTECT-VIII
  • Sponsors Bayer; Bayer HealthCare
  • Most Recent Events

    • 30 Oct 2017 According to a Bayer media release, the U.S. Food and Drug Administration (FDA) has accepted Bayer's Biologics License Application (BLA) filing for BAY94-9027, an extended half-life site-specifically PEGylated recombinant human Factor VIII compound, for the treatment of hemophilia A in adults and adolescents 12 years of age and over.
    • 31 Aug 2017 According to a Bayer media release, the company has submitted a BLA to the US FDA for BAY94-9027 for the treatment of Hemophilia A. The regulatory submission is essentially based on the results from this trial.
    • 11 Jun 2017 Planned End Date changed from 1 Feb 2017 to 15 Jan 2019.
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