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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07227246 | Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial - Part 2 | PHASE3 | RECRUITING | 350 | — | — | May 6, 2025 | Jun 1, 2029 | Apr 22, 2026 | 89 | United States, Canada +4 |
Ordinal distribution with the following steps: 0-2, 3, 4-6
| Arm | Type | Description |
|---|---|---|
| Recombinant Factor VIIa | EXPERIMENTAL | rFVIIa given as IV injection over 2 minutes within 120 minutes of stroke onset |
| Placebo | PLACEBO_COMPARATOR | Placebo given as IV injection over 2 minutes within 120 minutes of stroke onset |
| Name | Type | Description |
|---|---|---|
| Recombinant Factor VIIa | BIOLOGICAL | Participants will be randomized in a double-blinded fashion to rFVIIa 80 µg/kg dose (maximum 10 mg dose) or matching placebo. All participants in FASTEST Part 2 must have a positive spot sign on baseline CTA and be treated within 120 minutes of onset or patients treated within 90 minutes of stroke onset, with or without a positive spot sign. 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. |
| Biological/Vaccine: Placebo | BIOLOGICAL | Participants will be randomized in a double-blinded fashion to rFVIIa 80 µg/kg dose (maximum 10 mg dose) or matching placebo. All participants in FASTEST Part 2 must have a positive spot sign on baseline CTA and be treated within 120 minutes of onset or patients treated within 90 minutes of stroke onset, with or without a positive spot sign. 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 with a positive spot sign on pretreatment CT angiography or treatment within 90 minutes with or ...