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

This study has been completed.

First Received: June 30, 2005 Last Updated: May 15, 2009 History of Changes

Sponsored by:	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
Brain Contusion	Drug: activated recombinant human factor VII	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study
Official Title:	Evaluation of Safety and Preliminary Efficacy of Recombinant Activated Factor VII in Subjects With Brain Contusions

Resource links provided by NLM:

MedlinePlus related topics: Bruises Traumatic Brain Injury

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:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	F7CBI-1600, EudraCT No: 2004-000088-92
Study First Received:	June 30, 2005
Last Updated:	May 15, 2009
ClinicalTrials.gov Identifier:	NCT00123591 History of Changes
Health Authority:	Taiwan: Department of Health; Spain: Spanish Agency of Medicines; Singapore: Health Sciences Authority; Canada: Health Canada; Finland: National Agency for Medicines; 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

Study placed in the following topic categories:

Craniocerebral Trauma
Contusions
Wounds and Injuries
Central Nervous System Diseases
Disorders of Environmental Origin

Trauma, Nervous System
Wounds, Nonpenetrating
Brain Diseases
Brain Injuries

Additional relevant MeSH terms:

Craniocerebral Trauma
Contusions
Nervous System Diseases
Wounds and Injuries
Central Nervous System Diseases

Disorders of Environmental Origin
Trauma, Nervous System
Wounds, Nonpenetrating
Brain Diseases
Brain Injuries

ClinicalTrials.gov processed this record on August 28, 2009