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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
  Purpose
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 Intervention Phase
Hemophilia A Drug: NovoSeven Phase 3

Study Type: Interventional
Study Design: 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 NLM:


Further study details as provided by Medical University of Vienna:

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00375323


Locations
Austria
Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Sabine Eichinger, MD Medical University of Vienna
  More Information

ClinicalTrials.gov Identifier: NCT00375323     History of Changes
Other Study ID Numbers: NovoSeven 1
First Submitted: September 11, 2006
First Posted: September 12, 2006
Last Update Posted: April 20, 2007
Last Verified: April 2007

Keywords provided by Medical University of Vienna:
factor VIII inhibitor

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Factor VIII
Coagulants