Brief Title
Recombinant Factor VIIa (NovoSeven) on Restoring Coagulation Activation
Official Title
Effects of Recombinant Factor VIIa (NovoSeven) on Restoring Coagulation Activation in Patients With Hemophilia A and Antibodies to Factor VIII
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.
Study Phase
Phase 3
Study Type
Interventional
Condition
Hemophilia A
Intervention
NovoSeven
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Eligibility 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
Gender
Male
Ages
18 Years - N/A
Contacts
Sabine Eichinger, MD, ,
Location Countries
Austria
Location Countries
Austria
Administrative Informations
NCT ID
NCT00375323
Organization ID
NovoSeven 1
Study Sponsor
Medical University of Vienna
Study Sponsor
Sabine Eichinger, MD, Principal Investigator, Medical University of Vienna
Verification Date
April 2007