Efficacy, Safety, and Pharmacokinetics of Beroctocog Alfa in Patients Previously Treated for Hemophilia A.

ABSTRACT:

Purpose

Beroctocog alfa is a second generation recombinant factor VIII manufactured by removing the B-domain from factor VIII. This prospective clinical trial was conducted to evaluate the efficacy, safety, and pharmacokinetics of beroctocog alfa in patients of ages ≥12 years previously treated for severe hemophilia A.

Materials and methods

Seventy subjects received beroctocog alfa as an on-demand treatment for acute hemorrhage.

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 hemorrhages 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 subj

SUBMITTER: Hyun SY 

PROVIDER: S-EPMC4479860 | biostudies-literature | 2015 Jul

REPOSITORIES: biostudies-literature