Recombinant Activated Factor VII (rFVIIa) for Stroke

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
StrokeRecombinant Activated Factor VII (rFVIIa) - Biological
Eligibility
18 - 80
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether a drug called rFVIIa can improve outcomes for people who have had a spontaneous intracerebral hemorrhage (ICH), if it is given within 120 minutes of the stroke.

Eligible Conditions
  • Stroke

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 180 days

180 days
Modified Rankin Scale (mRS)
mRS
90 days
EQ-5D
Between baseline CT and 24-hour CT
Change in the volume of ICH and ICH+IVH

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Recombinant Activated Factor VII (rFVIIa)
1 of 2
Placebo
1 of 2

Active Control

Non-Treatment Group

860 Total Participants · 2 Treatment Groups

Primary Treatment: Recombinant Activated Factor VII (rFVIIa) · Has Placebo Group · Phase 3

Recombinant Activated Factor VII (rFVIIa)
Biological
ActiveComparator Group · 1 Intervention: Recombinant Activated Factor VII (rFVIIa) · Intervention Types: Biological
Placebo
Biological
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 180 days

Who is running the clinical trial?

Joseph Broderick, MDLead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,261 Previous Clinical Trials
454,102 Total Patients Enrolled
164 Trials studying Stroke
83,345 Patients Enrolled for Stroke
Novo Nordisk A/SIndustry Sponsor
1,405 Previous Clinical Trials
2,308,179 Total Patients Enrolled
1 Trials studying Stroke
380 Patients Enrolled for Stroke

Eligibility Criteria

Age 18 - 80 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are able to receive the study medication within 120 minutes of stroke onset or last known well.