A Phase 1/2a, Open-Label, Dose-Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetics of a Single Intravenous Injection of rFVIIIFc-VWF-XTEN (BIVV001) in Previously Treated Adults With Severe Hemophilia A

Trial Profile

A Phase 1/2a, Open-Label, Dose-Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetics of a Single Intravenous Injection of rFVIIIFc-VWF-XTEN (BIVV001) in Previously Treated Adults With Severe Hemophilia A

Planning
Phase of Trial: Phase I/II

Latest Information Update: 06 Jul 2017

At a glance

  • Drugs BIVV 001 (Primary)
  • Indications Haemophilia A
  • Focus Adverse reactions
  • Sponsors Bioverativ
  • Most Recent Events

    • 12 Jun 2017 According to a Bioverativ media release, U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application.
    • 03 Feb 2017 New trial record
    • 01 Feb 2017 According to a Bioverativ media release, this trial is expected to start in the second half of 2017.
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