Recombinant Factor VIIa (NovoSeven) on Restoring Coagulation Activation

Medical University of Vienna

Status and phase: Completed; Phase 3

Conditions: Hemophilia A

Treatments: Drug: NovoSeven

Study type: Interventional

Funder types: Other

Identifiers

NCT00375323

NovoSeven 1

Details and patient eligibility

About

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.

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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