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

Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 21 Sep 2018

At a glance

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

    • 13 Sep 2018 Planned End Date changed from 1 Sep 2018 to 1 Oct 2018.
    • 13 Sep 2018 Planned primary completion date changed from 1 Aug 2018 to 1 Oct 2018.
    • 29 May 2018 According to a Bioverativ media release, company has announced preliminary clinical data from this trial
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