Factor VIIa in Acute Intracerebral Haemorrhage

Phase 2

Completed

• Conditions: Intracerebral Haemorrhage; Acquired Bleeding Disorder

• Registration Number: NCT00266006
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Japan. The purpose of this trial is to evaluate the safety and preliminary efficacy of Activated Recombinant Factor VII (NN-007) in patients with acute intracerebral haemorrhage.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-12-14
• Study First Submitted QC: 2005-12-14
• Study First Posted: 2005-12-15
• Study Start: 2006-01
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-16
• Last Update Posted: 2016-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Spontaneous ICH

Exclusion Criteria

• Time of ICH onset > 3 hours
• Patients with secondary ICH
• Pre-existing disability
• Hemophilia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
The Occurrence of thromboembolic serious adverse event	Until 90 days

Secondary Outcome Measures

Name	Time	Method
Reducing disability and improving clinical outcome
Reducing haematoma growth

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇯🇵 Tokyo, Japan