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Sponsored by: |
Novo Nordisk |
---|---|
Information provided by: | Novo Nordisk |
ClinicalTrials.gov Identifier: | NCT00123591 |
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 |
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) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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 |
Study Director: | Michael Tillinger | Novo Nordisk |
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 |
Craniocerebral Trauma Contusions Wounds and Injuries Central Nervous System Diseases Disorders of Environmental Origin |
Trauma, Nervous System Wounds, Nonpenetrating Brain Diseases Brain Injuries |
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 |