Recombinant Factor VIIa (NovoSeven) on Restoring Coagulation Activation

This study has been completed.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00375323
First received: September 11, 2006
Last updated: April 19, 2007
Last verified: April 2007
  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: 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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00375323     History of Changes
Other Study ID Numbers: NovoSeven 1
Study First Received: September 11, 2006
Last Updated: April 19, 2007
Health Authority: Austria: Federal Ministry for Health and Women

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

ClinicalTrials.gov processed this record on September 30, 2014