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Also known as Recombinant Activated Factor VII (rFVIIa)
Recombinant Activated Factor VII · 1 trial · 1 indication
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...
Recombinant Activated Factor VII (rFVIIa) is being investigated for the treatment of intracerebral hemorrhage, a type of bleeding within the brain. 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 managing this serious neurological emergency.
Recombinant Activated Factor VII is a monoclonal antibody that targets the coagulation pathway. It works by activating factor VII, which plays a key role in the blood clotting cascade, potentially helping to reduce bleeding in patients with intracerebral hemorrhage. The drug is designed to promote hemostasis at the site of bleeding in the brain.
Recombinant Activated Factor VII is being developed by Novo Nordisk A/S, a global healthcare company. Novo Nordisk is listed on the stock exchange under the ticker symbol NVO. The company is conducting clinical trials to evaluate the safety and efficacy of this drug for intracerebral hemorrhage.
Recombinant Activated Factor VII is currently in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The ongoing Phase 3 trial is designed to evaluate its effectiveness and safety in patients with intracerebral hemorrhage, with results expected to inform potential regulatory submissions.
Recombinant Activated Factor VII is being studied in a Phase 3 clinical trial registered as NCT03496883, titled 'Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial'. This randomized, double-blind, placebo-controlled trial is enrolling 860 participants with intracerebral hemorrhage across the United States, Canada, Germany, Japan, Spain, and the United Kingdom.
Yes, Recombinant Activated Factor VII is also known as rFVIIa. The abbreviation rFVIIa stands for recombinant activated factor VII, which is the same drug. This naming is commonly used in clinical and research settings to refer to this investigational therapy for intracerebral hemorrhage.