Recombinant Factor VIIa (NovoSeven) on Restoring Coagulation Activation

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.

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Key information

Conditions

Hemophilia A Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Medical University of Vienna

Vienna, 1090, Austria

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NovoSeven

Drug

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Effects of Recombinant Factor VIIa (NovoSeven) on Restoring Coagulation Activation in Patients With Hemophilia A and Antibodies to Factor VIII

Important dates

First posted: Sep 12, 2006
Registry last updated: Apr 20, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed