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

Trial Profile

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

Recruiting
Phase of Trial: Phase III

Latest Information Update: 31 Jul 2017

At a glance

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

    • 26 Jul 2017 Status changed from active, no longer recruiting to recruiting.
    • 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 According to a Genentech media release, data from this (HAVEN 2) and other (HAVEN 1) study is submitted to the FDA and EMA for approval consideration.
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