A Randomized, Multicenter, Open-Label, Phase III Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Patients With Inhibitors

Trial Profile

A Randomized, Multicenter, Open-Label, Phase III Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Patients With Inhibitors

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 21 Jul 2017

At a glance

  • Drugs Emicizumab (Primary)
  • Indications Haemophilia A
  • Focus Registrational; Therapeutic Use
  • Acronyms HAVEN 1
  • Sponsors Chugai Pharmaceutical; Roche
  • Most Recent Events

    • 21 Jul 2017 According to a Chugai Pharmaceutical media release, based on the data of HAVEN 1 study and the interim analysis of HAVEN 2 study, Company has submitted new drug application of emicizumab for the planned indication of "Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with congenital factor VIII deficiency (hemophilia A) with factor VIII inhibitors in Japan.
    • 10 Jul 2017 Results published in a Roche Media Release.
    • 10 Jul 2017 According to a Roche media release, data from this study were published in The New England Journal of Medicine (NEJM).
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