지원사업
학술연구/단체지원/교육 등 연구자 활동을 지속하도록 DBpia가 지원하고 있어요.
커뮤니티
연구자들이 자신의 연구와 전문성을 널리 알리고, 새로운 협력의 기회를 만들 수 있는 네트워킹 공간이에요.
논문 기본 정보
- 자료유형
- 학술저널
- 저자정보
- 발행연도
- 2015.1
- 수록면
- 935 - 943 (9page)
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초록· 키워드
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Purpose: Beroctocog alfa is a second generation recombinant factor VIII manufacturedby 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. Materialsand 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 efficacyrate of 87.1%. The majority of acute hemorrhages was treated by administeringthe 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 dyspnea and facial edema) in one subject were related to the study drug. Only one subject formed a de novo factor VIII inhibitor, for an occurrencerate of 1.4% (one-sided 95% upper confidence limit: 3.85%). The final eliminationhalf-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 efficaciousas either an on-demand treatment for acute hemorrhage or a surgical prophylaxisin patients with hemophilia A.
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참고문헌 (20)
참고문헌 신청
Abshire TC / 2000 / Sucrose formulated recombinant human antihemophilic factor VIII is safe and efficacious for treatment of hemophilia A in home therapy--International Kogen
Bray GL / 1994 / A multicenter study of recombinant factor VIII (recombinate): safety, efficacy, and inhibitor risk in previously untreated patients with hemophilia A. The Re
Chun BH / 2003 / Enhanced production of recombinant B-domain deleted factor VIII from Chinese hamster ovary cells by propionic and butyric acids / Biotechnol Lett 25 : 315 ~
Courter SG / 2001 / Clinical evaluation of B-domain deleted recombinant factor VIII in previously untreated patients / Semin Hematol 38 (2 Suppl) : 52 ~ 59
D’Amici GM / 2010 / Recombinant clotting factor VIII concentrates: heterogeneity and high-purity evaluation / Electrophoresis 31 : 2730 ~ 2739
Bray GL / 1994 / A multicenter study of recombinant factor VIII (recombinate): safety, efficacy, and inhibitor risk in previously untreated patients with hemophilia A. The Re
Chun BH / 2003 / Enhanced production of recombinant B-domain deleted factor VIII from Chinese hamster ovary cells by propionic and butyric acids / Biotechnol Lett 25 : 315 ~
Courter SG / 2001 / Clinical evaluation of B-domain deleted recombinant factor VIII in previously untreated patients / Semin Hematol 38 (2 Suppl) : 52 ~ 59
D’Amici GM / 2010 / Recombinant clotting factor VIII concentrates: heterogeneity and high-purity evaluation / Electrophoresis 31 : 2730 ~ 2739
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