Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01757405 | Recombinant Factor VIIa BI (rFVIIa BI) Treatment of Acute Bleeding Episodes Per an On-demand Regimen | PHASE3 | COMPLETED | 40 | — | — | Feb 20, 2013 | Nov 11, 2014 | May 11, 2021 | 16 | United States, Japan +7 |
No additional hemostatic product required within 12 hours of first dose other than the prescribed dosing regimen.
| Arm | Type | Description |
|---|---|---|
| ≤ 3 doses of 90 µg/kg rFVIIa BI | EXPERIMENTAL | - |
| One dose of 270 µg/kg rFVIIa BI | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Recombinant Factor VIIa BI (rFVIIa BI) | BIOLOGICAL | Administered approximately every 3 hours as an intravenous bolus injection on-demand |
Main Inclusion Criteria: * Participant is male with hemophilia A or B with inhibitors, with a high titer (≥5 Bethesda unit (BU)) or a historical high anamnestic response. * Participant is 12 to 65 years old at the time of screening. * Participant is currently using or has used bypassing agents for ...