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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomised, Double-Blind, Placebo-Controlled, Multi-centre, Dose Escalation Study to Evaluate the Safety and Preliminary Efficacy of Recombinant Factor VIIa (NovoSeven®/NiaStase®) in Subje

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 Summary:
Sponsor: Novo Nordisk A/S

Current Primary Outcome: Evaluate the Safety of Recombinant Activated Factor VII in Subjects with Brain Contusions [ Time Frame: Within the first 15 days of injury ]

Original Primary Outcome: Evaluate the Safety and Preliminary Efficacy of Recombinant Factor VIIa (NovoSeven/NiaStase) in Subjects with Brain Contusions

Current Secondary Outcome: Evaluate the preliminary efficacy of Recombinant Activated Factor VII in preventing haemorrhagic progression in brain contusions

Original Secondary Outcome:

Information By: Novo Nordisk A/S

Dates:
Date Received: June 30, 2005
Date Started: January 2005
Date Completion:
Last Updated: January 11, 2017
Last Verified: January 2017