Recombinant Factor VIIa in Acute Intracerebral Haemorrhage (FAST)

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Intracerebral Haemorrhage; Acquired Bleeding Disorder

Treatments: Drug: eptacog alfa (activated)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00127283

2004-004202-24 (EudraCT Number)

F7ICH-1641

Details and patient eligibility

About

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.

Enrollment: 829 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Spontaneous intracranial hemorrhage (ICH) within 3 hours after first symptom

Exclusion criteria

• Patients with secondary ICH
• Pre-existing disability
• Haemophilia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind