Efficacy, Safety, and Pharmacokinetics of Beroctocog Alfa in @entity1 Previously Treated for XXXX .

@entity1 @entity548 @entity1353 @entity447 @entity4 @entity797
PURPOSE: Beroctocog alfa is a second generation recombinant factor @entity797 manufactured by removing the B-domain from factor @entity797 . This prospective clinical trial was conducted to evaluate the efficacy, safety, and pharmacokinetics of beroctocog alfa in @entity1 of ages >= 12 years previously treated for severe @entity447 . MATERIALS AND METHODS: Seventy subjects received beroctocog alfa as an on-demand treatment for acute @entity548 . RESULTS: The final hemostatic effect was excellent in 35 subjects (50%) and good in 26 subjects (37.1%). The drug showed an overall efficacy rate of 87.1%. The majority of acute @entity548 was treated by administering the study drug once (86.2%) or twice (10.0%), and the mean dose administered per single infusion was 28.55  6.53 IU/kg. Ten subjects underwent 12 surgical procedures, and hemostatic efficacy was excellent in seven cases (58.3%) and good in five cases (41.7%), showing a 100% efficacy rate. A total of 52 of 88 subjects (59.0%) experienced 168 adverse events. There were 18 serious adverse events (10.7%) in 11 subjects, and two (mild @entity1353 and @entity4 ) in one subject were related to the study drug. Only one subject formed a de novo factor @entity797 inhibitor, for an occurrence rate of 1.4% (one-sided 95% upper confidence limit: 3.85%). The final elimination half-life was 13.3 h and 12.6 h at baseline and 6 months after administration, respectively. CONCLUSION: Our results suggest that beroctocog alfa is safe and efficacious as either an on-demand treatment for acute @entity548 or a surgical prophylaxis in @entity1 with @entity447 .
