Recombinant Factor VIIa (NovoSeven) on Restoring Coagulation Activation

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3

Details

• Lead Sponsor: Medical University of Vienna
• Treatments: Factor VIII

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