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Recombinant Factor VIIa · 1 trial · 1 indication
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 ...
Recombinant Factor VIIa is being investigated for the treatment of Intracerebral Hemorrhage, a type of hemorrhagic stroke. It is currently in Phase 3 clinical development as an investigational therapy for this condition. The drug is being studied to assess its potential benefit in patients with this serious neurological emergency.
Recombinant Factor VIIa is a monoclonal antibody that targets and activates the coagulation cascade, specifically by binding to tissue factor and factor VIIa to promote clot formation. This mechanism is being studied for its potential to limit bleeding in patients with Intracerebral Hemorrhage, though the drug remains investigational.
Recombinant Factor VIIa is being developed by Novo Nordisk A/S, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVO. The company is conducting a Phase 3 clinical trial to evaluate this drug for the treatment of Intracerebral Hemorrhage.
Recombinant Factor VIIa is currently in Phase 3 clinical development for Intracerebral Hemorrhage. It is an investigational drug and has not been approved by regulatory authorities for this indication. The ongoing Phase 3 trial is actively recruiting participants to evaluate the drug's safety and efficacy.
Recombinant Factor VIIa is being studied in a Phase 3 clinical trial registered as NCT07227246, titled 'Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial - Part 2'. This randomized, double-blind, placebo-controlled trial is recruiting 350 participants across the United States, Canada, Germany, Japan, Spain, and the United Kingdom.
Yes, Recombinant Factor VIIa is also known as rFVIIa. The ongoing Phase 3 clinical trial for Intracerebral Hemorrhage, NCT07227246, uses the abbreviated name rFVIIa in its title. This investigational drug is being developed by Novo Nordisk A/S for the treatment of hemorrhagic stroke.