NCT00123591|CompletedPhase 2

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

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 Subjects With Brain Contusions

Novo Nordisk A/S ClinicalTrials.gov

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2 other identifiers

F7CBI-16002004-000088-92

Study Type

interventional

Target

Locations

11 countries

Sites

Timeline

RegisteredJul 2005

StartedJan 2005

CompletionMay 2006

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Jan 2005

Shorter than P25 for phase_2

Geographic Reach

11 countries

15 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.3 years study duration

Study Start

First participant enrolled

January 1, 2005

Completed

6 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2005

Completed

25 days until next milestone

First Posted

Study publicly available on registry

July 25, 2005

Completed

9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed

Last Updated

January 12, 2017

Status Verified

January 1, 2017

Enrollment Period

1.3 years

First QC Date

June 30, 2005

Last Update Submit

January 11, 2017

Conditions

Acquired Bleeding Disorder Trauma

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

activated recombinant human factor VIIDRUG

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

Contact the study team to confirm eligibility.