In a prospective, open-label, international, multi-centre Phase III study (GENA-08) 32 adult PTPs with severe hemophilia A received Nuwiq® prophylaxis. Of the 32 subjects, 24 had at least 50 EDs and were followed for at least 6 months. Thirty-one subjects accumulated more than 50 EDs and the same 31 subjects stayed in the study for at least 176 days. The mean prophylactic dose was 32.8 IU/kg and was administered every other day. In the pivotal study, 50% of patients experienced no bleeding. The overall efficacy of prophylactic treatment was evaluated based on the rate of bleeding episodes (BEs).