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NCT00375323 Clinical Trial

Recombinant Factor VIIa (NovoSeven) on Restoring Coagulation Activation

Hemophilia A Clinical Trial

Official title:
Effects of Recombinant Factor VIIa (NovoSevenīƒ’) on Restoring Coagulation Activation in Patients With Hemophilia A and Antibodies to Factor VIII

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00375323
Other study ID # NovoSeven 1
Secondary ID
Status Completed
Phase Phase 3
First received September 11, 2006
Last updated April 19, 2007

Study information
Verified date April 2007
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority Austria: Federal Ministry for Health and Women
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Male
Age group 18 Years and older
Eligibility 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

Allocation: Non-Randomized, Intervention Model: Factorial Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Drug:
• NovoSeven

Locations
Country Name City State
Austria Medical University of Vienna Vienna

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

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