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

Recruiting
Phase of Trial: Phase III

Latest Information Update: 30 Nov 2017

At a glance

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

    • 16 Nov 2017 Results presented in a Roche media release.
    • 16 Nov 2017 According to a Chugai Pharmaceuticals media release, the US FDA has approved emicizumab for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors. The approval was based on data from HAVEN 1 and HAVEN 2 studies.
    • 02 Nov 2017 According to a Chugai Pharmaceutical media release, data will be presented at The American Society of Hematology (ASH) 2017.
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