drugset / Trial / NCT01757405
Recombinant Factor VIIa BI (rFVIIa BI) Treatment of Acute Bleeding Episodes Per an On-demand Regimen
RandomizedSingle-groupOpen-labelTreatment
Summary
The purpose of the study is to determine the efficacy and safety of rFVIIa BI as part of a six-month on-demand treatment regimen in hemophilia A or B subjects with inhibitors.
Timeline
- Start
- 2013-02-20
- Primary completion
- 2014-11-11
- Completion
- 2014-11-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Recombinant Factor VIIa BI | Protein / enzyme biologic | 90 ug/kg | Intravenous |
| Subject | Recombinant Factor VIIa BI | Protein / enzyme biologic | 270 ug/kg | Intravenous |