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

NCT ID: NCT00123591

Last Updated: 2017-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2006-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Acquired Bleeding Disorder Trauma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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activated recombinant human factor VII

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Montreal, , Canada

Site Status

Novo Nordisk Investigational Site

Helsinki, , Finland

Site Status

Novo Nordisk Investigational Site

Hanover, , Germany

Site Status

Novo Nordisk Investigational Site

New Dehli, New Delhi, India

Site Status

Novo Nordisk Investigational Site

Bangalore, , India

Site Status

Novo Nordisk Investigational Site

Haifa, , Israel

Site Status

Novo Nordisk Investigational Site

Ramat Gan, , Israel

Site Status

Novo Nordisk Investigational Site

Tel Aviv, , Israel

Site Status

Novo Nordisk Investigational Site

Cesena, , Italy

Site Status

Novo Nordisk Investigational Site

Rotterdam, , Netherlands

Site Status

Novo Nordisk Investigational Site

Singapore, , Singapore

Site Status

Novo Nordisk Investigational Site

Singapore, , Singapore

Site Status

Novo Nordisk Investigational Site

Barcelona, , Spain

Site Status

Novo Nordisk Investigational Site

Zurich, , Switzerland

Site Status

Novo Nordisk Investigational Site

Taoyuan District, , Taiwan

Site Status

Countries

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Canada Finland Germany India Israel Italy Netherlands Singapore Spain Switzerland Taiwan

References

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Narayan RK, Maas AI, Marshall LF, Servadei F, Skolnick BE, Tillinger MN; rFVIIa Traumatic ICH Study Group. Recombinant factor VIIA in traumatic intracerebral hemorrhage: results of a dose-escalation clinical trial. Neurosurgery. 2008 Apr;62(4):776-86; discussion 786-8. doi: 10.1227/01.neu.0000316898.78371.74.

Reference Type RESULT
PMID: 18496183 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2004-000088-92

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

F7CBI-1600

Identifier Type: -

Identifier Source: org_study_id

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