The PROTECT VIII main and extension studies were designed to reflect real-world treatment1,2

Study Design Chart
  • As of January 2018 interim analysis.2
  • 112 patients entered prophylactic treatment arms; an additional 20 patients entered a control arm of on-demand treatment. Two patients in the prophylactic arms left the main study prematurely during the run-in period.1
  • Defined as joint or muscle bleeds and no identified trauma.1,3
  • 121 of 134 patients included in the main PROTECT VIII trial continued in the extension study, receiving either on-demand treatment (n=14) or prophylaxis (n=107).2
  • Patients who switched dosing frequency at least once after the first week of the extension study were analyzed in a separate variable-frequency group.