Recombinant Factor VIIa in Acute Intracerebral Haemorrhage

Phase 2

Completed

• Conditions: Acquired Bleeding Disorder; Intracerebral Haemorrhage

• Registration Number: NCT00426803
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-08
• Primary Completion: 2004-06
• Study Completion: 2004-06
• Study First Submitted: 2007-01-24
• Study First Submitted QC: 2007-01-24
• Study First Posted: 2007-01-25
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-17
• Last Update Posted: 2017-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Reducing haematoma growth

Secondary Outcome Measures

Name	Time	Method
Reducing disability and improving clinical outcome

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 Newcastle Upon Tyne, United Kingdom