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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03496883 | Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial | PHASE3 | ACTIVE NOT_RECRUITING | 860 | — | — | Dec 3, 2021 | Jan 1, 2028 | Jan 21, 2026 | 88 | United States, Canada +4 |
Ordinal distribution with the following steps: 0-2, 3, 4-6
| Arm | Type | Description |
|---|---|---|
| Recombinant Activated Factor VII (rFVIIa) | ACTIVE_COMPARATOR | rFVIIa given as IV injection over 2 minutes within 120 minutes of stroke onset |
| Placebo | PLACEBO_COMPARATOR | Matching placebo given as IV injection over 2 minutes within 120 minutes of stroke onset |
| Name | Type | Description |
|---|---|---|
| Recombinant Activated Factor VII (rFVIIa) | BIOLOGICAL | Participants will be randomized in a double-blinded fashion to rFVIIa 80 µg/kg dose (maximum 10 mg dose) or matching placebo. Participants in both arms will receive best standard therapy as per published AHA Guidelines for ICH, including a target systolic blood pressure of 140 mm Hg. |
| Placebo | BIOLOGICAL | Participants will be randomized in a double-blinded fashion to rFVIIa 80 µg/kg dose (maximum 10 mg dose) or matching placebo. Participants in both arms will receive best standard therapy as per published AHA Guidelines for ICH, including a target systolic blood pressure of 140 mm Hg. |
Inclusion Criteria: 1. Patients aged 18-80 years, inclusive 2. Patients with spontaneous ICH 3. Able to treat with study medication (rFVIIa/placebo) within 120 minutes of stroke onset or last known well 4. Efforts to obtain informed consent per EFIC guidelines (U.S.) or adherence to country-specifi...