Efficacy, Safety, and Pharmacokinetics of Beroctocog Alfa in Patients Previously Treated for Hemophilia A
Yonsei Medical Journal
; : 935-943, 2015.
Article
em En
| WPRIM
| ID: wpr-40871
Biblioteca responsável:
WPRO
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 > or =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 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 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 hemorrhage or a surgical prophylaxis in patients with hemophilia A.
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Texto completo:
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Base de dados:
WPRIM
Assunto principal:
Proteínas Recombinantes
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Fator VIII
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Estudos Prospectivos
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Resultado do Tratamento
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Qualidade de Produtos para o Consumidor
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Dispneia
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Hemofilia A
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Hemorragia
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Hemostasia
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Hemostasia Cirúrgica
Tipo de estudo:
Clinical_trials
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Observational_studies
Limite:
Adult
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Female
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Humans
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Male
Idioma:
En
Revista:
Yonsei Medical Journal
Ano de publicação:
2015
Tipo de documento:
Article