Recombinant Factor VIIa in Acute Intracerebral Haemorrhage

Novo Nordisk

Status and phase: Completed; Phase 2

Conditions: Intracerebral Haemorrhage; Acquired Bleeding Disorder

Treatments: Drug: activated recombinant human factor VII

Study type: Interventional

Funder types: Industry

Identifiers

NCT00426803

F7ICH-1371

Details and patient eligibility

About

This trial is conducted in North America, Europe, Asia and Oceania. The purpose of this study is to evaluate safety and efficacy of Recombinant Factor VIIa in patients with acute intracerebral bleeding.

Enrollment: 400 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Spontaneous intracranial haemorrhage (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