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Recombinant Factor VIIa (NovoSeven) on Restoring Coagulation Activation

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. Identifier: NCT00375323
Recruitment Status : Completed
First Posted : September 12, 2006
Last Update Posted : April 20, 2007
Information provided by:
Medical University of Vienna

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hemophilia A Drug: NovoSeven Phase 3

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Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Official Title: Effects of Recombinant Factor VIIa (NovoSeven) on Restoring Coagulation Activation in Patients With Hemophilia A and Antibodies to Factor VIII

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemophilia

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00375323

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Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
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Principal Investigator: Sabine Eichinger, MD Medical University of Vienna
Layout table for additonal information Identifier: NCT00375323    
Other Study ID Numbers: NovoSeven 1
First Posted: September 12, 2006    Key Record Dates
Last Update Posted: April 20, 2007
Last Verified: April 2007
Keywords provided by Medical University of Vienna:
factor VIII inhibitor
Additional relevant MeSH terms:
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Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn