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Also known as Recombinant Activated Factor VII (rFVIIa), Recombinant Activated Factor VII, Recombinant Factor VIIa
NovoSeven · 2 trials · 1 indication
Ordinal distribution with the following steps: 0-2, 3, 4-6
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 |
| Recombinant Activated Factor VII (rFVIIa) | ACTIVE_COMPARATOR | rFVIIa 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. |
| 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 with a positive spot sign on pretreatment CT angiography or treatment within 90 minutes with or ...