Recombinant Factor VIIa in Acute Intracerebral Haemorrhage "FAST"

Completed

Phase 3 Results

Trial Description

This trial is conducted in Asia, Europe, Middle East, North America, Oceania, and South America.
The purpose of this study is to evaluate the treatment of Recombinant Factor VIIa (eptacog alfa (activated)) in patients with acute intracerebral bleeding. It is expected that more patients will recover without severe permanent disability after acute treatment with Recombinant Factor VIIa by reducing further intracerebral bleeding.

Conditions

Interventions

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Patients will be randomised to one of three treatment arms: placebo, and rFVIIa 20 or 80 mcg/kg. Assigned treatment will be administered no more than 4 hours after symptom onset, and no more than 1 hour after baseline CT scan.

Outcomes

Type Measure Time Frame Safety Issue
Primary Reducing disability and improving clinical outcome after 3 months.
Secondary Reducing hematoma growth and mortality.
Primary Reducing disability and improving clinical outcome After 3 months No
Secondary Reducing mortality No
Secondary Reducing hematoma growth No

Sponsors