Trial of Recombinant Factor VIIa rFVIIa for Acute Spontaneous Intracerebral Hemorrhage Treatment Within 2 Hours of Stroke Onset

What this Trial Is About

Researchers are evaluating recombinant Factor VIIa rFVIIa as a potential treatment for acute spontaneous intracerebral hemorrhage ICH, a type of stroke caused by bleeding in the brain. This global Phase III trial, called FASTEST Part 2, aims to identify the subgroup of patients most likely to benefit when treated early, within 120 minutes of stroke onset. The study compares rFVIIa plus best standard care against placebo plus best standard care, focusing on improving outcomes measured by the Modified Rankin Scale at 90 days and reducing ongoing bleeding. Participants will be randomly assigned to receive either rFVIIa at a dose of 80 micrograms per kilogram up to 10 mg or a matching placebo. Both treatments are given as an intravenous injection over 2 minutes within 120 minutes of stroke onset. All participants will also receive the best standard therapy according to guidelines, including blood pressure management targeting a systolic pressure of 140 mm Hg. The trial includes patients with specific brain hemorrhage volumes and timing criteria, with some treated within 90 minutes regardless of certain imaging findings. Emergency consent procedures and mobile stroke units are used to enable rapid treatment. During the study, participants will have brain scans at baseline and 24 hours to measure bleeding volume and swelling. Assessments of disability and quality of life will be conducted remotely at 30, 90, and 180 days after treatment. The main outcome is the disability level at 90 days, and safety and other effects will be monitored throughout. Participation may last up to six months, with follow-up assessments to evaluate recovery and treatment impact over time.

Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial - Part 2