Recombinant Factor VIIa in Acute Intracerebral Haemorrhage

Phase 3

Completed

• Conditions: Acquired Bleeding Disorder; Intracerebral Haemorrhage

• Registration Number: NCT00127283
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2005-08-03
• Study First Submitted QC: 2005-08-03
• Study First Posted: 2005-08-05
• Primary Completion: 2007-01
• Study Completion: 2007-01
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 829

Inclusion Criteria

• Spontaneous intracranial hemorrhage (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 disability and improving clinical outcome	After 3 months

Secondary Outcome Measures

Name	Time	Method
Reducing mortality
Reducing hematoma growth

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇹🇭 Bangkok, Thailand