Safety and Preliminary Efficacy of Recombinant Activated Factor VII in Subjects With Traumatic Brain Injury - Full Text View

Sponsor:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00123591

Purpose

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.

Condition	Intervention	Phase
Trauma	Drug: activated recombinant human factor VII	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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 Subjects With Brain Contusions

Resource links provided by NLM:

MedlinePlus related topics: Bruises Injuries Traumatic Brain Injury Wounds

Drug Information available for: Eptacog alfa

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Evaluate the Safety of Recombinant Activated Factor VII in Subjects with Brain Contusions [ Time Frame: Within the first 15 days of injury ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluate the preliminary efficacy of Recombinant Activated Factor VII in preventing haemorrhagic progression in brain contusions [ Designated as safety issue: No ]

Enrollment:	96
Study Start Date:	January 2005
Study Completion Date:	May 2006
Primary Completion Date:	May 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00123591

Locations

Canada

Toronto, Canada
Finland

Helsinki, Finland
Germany

Ulm, Germany
India

New Delhi, India
Israel

Tel-Aviv, Israel
Italy

Cesena, Italy
Netherlands

Rotterdam, Netherlands
Singapore

Singapore, Singapore
Spain

Barcelona, Spain
Switzerland

Zürich, Switzerland
Taiwan

Taoyuan, Taiwan

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Michael Tillinger

Novo Nordisk

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT00123591 History of Changes
Other Study ID Numbers:	F7CBI-1600, 2004-000088-92
Study First Received:	June 30, 2005
Last Updated:	January 23, 2012
Health Authority:	Taiwan: Department of Health; Spain: Spanish Agency of Medicines; Singapore: Health Sciences Authority; Canada: Health Canada; Finland: Finnish Medicines Agency; Italy: Ministry of Health; Germany: Paul-Ehrlich-Institut; Israel: Israeli Health Ministry Pharmaceutical Administration; Switzerland: Swissmedic; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); India: Ministry of Health

Additional relevant MeSH terms:

Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on February 09, 2012