A Clinical Trial to Evaluate Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Participants Without Inhibitors (HAVEN 3)

This is a randomized, global, multicenter, open-label, Phase 3 clinical study in participants with severe hemophilia A without inhibitors against Factor VIII (FVIII) who are 12 years or older. The study evaluates two prophylactic emicizumab regimens versus no prophylaxis in this population with emphasis on efficacy, safety, and pharmacokinetics.


Study Type: Interventional  (Clinical Trial)
Actual Enrollment: 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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 Without Inhibitors
Actual Study Start Date: September 27, 2016
Primary Completion Date: September 15, 2017
Estimated Study Completion Date: September 30, 2019

Arms and Interventions:
- Experimental: Emicizumab 1.5 mg/kg/week
- Experimental: Emicizumab 3 mg/kg/2 weeks
- Active Comparator: No Prophylaxis
- Experimental: Emicizumab (Pre-study FVIII Prophylaxis)