Recombinant Factor VIIa (NovoSeven) on Restoring Coagulation Activation

Phase 3

Completed

• Conditions: Hemophilia A

• Registration Number: NCT00375323
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-09-11
• Study First Submitted QC: 2006-09-11
• Study First Posted: 2006-09-12
• Status Verified: 2007-04
• Last Update Submitted: 2007-04-19
• Last Update Posted: 2007-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria