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: 30 Sep 2017

At a glance

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

    • 24 Aug 2017 According to a Chugai Pharmaceutical media release, based on the data from HAVEN 1 and HAVEN 2 trials, the US FDA has accepted the Biologics License Application (BLA) and has granted Priority Review for emicizumab prophylaxis (preventative) as a once-weekly subcutaneous treatment for adults, adolescents and children with hemophilia A with factor VIII inhibitors. The decision on approval is expected by February 23, 2018.
    • 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.
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