Safety and Preliminary Efficacy of Recombinant Activated Factor VII in Subjects With Traumatic Brain Injury

Phase 2

Completed

• Conditions: Acquired Bleeding Disorder; Trauma

• Registration Number: NCT00123591
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Asia, Europe, Middle East, and North America. The primary objective of the trial is to evaluate the safety of Recombinant Activated Factor VII in patients with brain contusions. The secondary objective of the trial is to evaluate the preliminary efficacy of Recombinant Activated Factor VII in preventing early haemorrhagic progression in contusive brain injury.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-06-30
• Study First Submitted QC: 2005-07-13
• Study First Posted: 2005-07-25
• Primary Completion: 2006-05
• Study Completion: 2006-05
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• Contusive brain injury (including brain stem) diagnosed by history, clinical examination and confirmed by CT scan within 6 hours of onset
• In British Columbia and Nova Scotia, subjects must be = 19 years.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Evaluate the Safety of Recombinant Activated Factor VII in Subjects with Brain Contusions	Within the first 15 days of injury

Secondary Outcome Measures

Name	Time	Method
Evaluate the preliminary efficacy of Recombinant Activated Factor VII in preventing haemorrhagic progression in brain contusions

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇨🇳 Taoyuan, Taiwan