A Multicenter, Open-Label, Phase III Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous Administration of Emicizumab in Hemophilia A Pediatric Patients With Inhibitors

Trial Profile

A Multicenter, Open-Label, Phase III Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous Administration of Emicizumab in Hemophilia A Pediatric Patients With Inhibitors

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 17 Apr 2018

At a glance

  • Drugs Emicizumab (Primary)
  • Indications Haemophilia A
  • Focus Registrational; Therapeutic Use
  • Acronyms HAVEN2
  • Sponsors Chugai Pharmaceutical; Roche
  • Most Recent Events

    • 23 Mar 2018 According to a Chugai Pharmaceutical media release, based on data from HAVEN 1 and HAVEN 2 studies, the Ministry of Health, Labour and Welfare has approved HEMLIBRA Subcutaneous Injection 30mg, 60mg, 90mg, 105mg, 150mg for 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.
    • 27 Feb 2018 According to a Chugai Pharmaceutical media release, based on data from HAVEN 1 and HAVEN 2 studies, the European Commission has approved HEMLIBRA (emicizumab) for routine prophylaxis of bleeding episodes in people with hemophilia A with factor VIII inhibitors.
    • 27 Feb 2018 Results published in the Roche Media Release
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