Efficacy, Safety, and Pharmacokinetics of Beroctocog Alfa in Patients Previously Treated for Hemophilia A
Yonsei Medical Journal
;
: 935-943, 2015.
Article
in English
| WPRIM
| ID: wpr-40871
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 ANDMETHODS:
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.
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
Recombinant Proteins
/
Factor VIII
/
Prospective Studies
/
Treatment Outcome
/
Consumer Product Safety
/
Dyspnea
/
Hemophilia A
/
Hemorrhage
/
Hemostasis
/
Hemostasis, Surgical
Type of study:
Controlled clinical trial
/
Observational study
Limits:
Adult
/
Female
/
Humans
/
Male
Language:
English
Journal:
Yonsei Medical Journal
Year:
2015
Type:
Article
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