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Recombinant Factor VIIa (NovoSeven) on Restoring Coagulation Activation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00375323
First Posted: September 12, 2006
Last Update Posted: April 20, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Medical University of Vienna
September 11, 2006
September 12, 2006
April 20, 2007
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Complete list of historical versions of study NCT00375323 on ClinicalTrials.gov Archive Site
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Recombinant Factor VIIa (NovoSeven) on Restoring Coagulation Activation
Effects of Recombinant Factor VIIa (NovoSeven) on Restoring Coagulation Activation in Patients With Hemophilia A and Antibodies to Factor VIII
The purpose of the study is to compare the effects of recombinant factor VIIa (NovoSeven) on restoring coagulation activation between patients with hemophilia A and antibodies to factor VIII and normal subjects (controls) by use of an in vivo method.
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Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Hemophilia A
Drug: NovoSeven
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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Inclusion Criteria:

  • Adult patients with hemophilia A and current antibodies to factor VIII -

Exclusion Criteria:

  • Life-threatening hemorrhage
  • Severe liver failure
  • Any other severe co-morbidity (including diabetes mellitus, renal failure, cancer, septicemia, disseminated intravascular coagulation, crush injury)
  • Exposure to other haemostatic drugs during the previous 7 days
  • Hypersensitivity to hamster, mouse or bovine proteins
  • Known or suspected allergy to NovoSeven or any of its components
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
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Contact information is only displayed when the study is recruiting subjects
Austria
 
 
NCT00375323
NovoSeven 1
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Medical University of Vienna
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Principal Investigator: Sabine Eichinger, MD Medical University of Vienna
Medical University of Vienna
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP