In the PROTECT VIII main study

Median Jivi® doses were within recommended label dosing

Study Design Chart
  • Patients received prophylactic therapy for 26 weeks after a 10-week run-in period of twice weekly 25 IU/kg. Patients that had high bleeding tendency (>1 breakthrough bleeds during the run-in) continued on twice-weekly 30-40 IU/kg. Patients with ≤1 breakthrough bleeds during the run-in were randomized to less frequent dosing of every 5 days (45-60 IU/kg) or every 7 days. After randomization groups were full, remaining eligible patients continued with twice-weekly 30-40 IU/kg.2


In the PROTECT VIII extension study

Median Jivi® doses were within recommended label dosing

Study Design Chart
  • Patients who switched at least once after the first week of the extension study were analyzed in a separate variable frequency group.3
     
  • As of January 2018 interim analysis.3
  • Patients received prophylactic therapy for 26 weeks after a 10-week run-in period of twice-weekly 25 IU/kg. Patients who had high bleeding tendency (>1 breakthrough bleed during the run-in) continued on twice-weekly 30-40 IU/kg. Patients with ≤1 breakthrough bleed during the run-in were randomized to less frequent dosing of every 5 days (45-60 IU/kg) or every 7 days. After randomization groups were full, remaining eligible patients continued with twice-weekly 30-40 IU/kg.2