Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Recombinant Activated Factor VII (rFVIIa), Recombinant Activated Factor VII, Recombinant Factor VIIa, NiaStase
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 ...
NovoSeven is being studied as a treatment for intracerebral hemorrhage, a type of bleeding stroke. It is given to patients with this condition to evaluate its effects in Phase 3 clinical trials. The trials enroll adults aged 18 and older and are conducted in multiple countries including the United States, Canada, Germany, Japan, Spain, and the United Kingdom.
NovoSeven is developed by Novo Nordisk A/S, which trades under the ticker NVO. The company is running the clinical development program for the drug in intracerebral hemorrhage.
NovoSeven is in Phase 3 clinical development for intracerebral hemorrhage. It is investigational and has not been approved for this indication. Two Phase 3 trials are underway, one recruiting and one active but not recruiting, with a combined planned enrollment of 1,210 participants.
NovoSeven is being tested in two Phase 3 trials for intracerebral hemorrhage: NCT07227246, titled Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial - Part 2, which is recruiting 350 participants, and NCT03496883, titled Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial, which is active but not recruiting 860 participants.
Yes, NovoSeven is also known as recombinant activated factor VII, abbreviated rFVIIa, and recombinant factor VIIa. These names refer to the same drug candidate being studied by Novo Nordisk for intracerebral hemorrhage.