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Sponsored by: |
Novo Nordisk |
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Information provided by: | Novo Nordisk |
ClinicalTrials.gov Identifier: | NCT00571584 |
This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and safety of two dose schedules of activated recombinant human factor VII in treatment of joint bleeds in haemophilia patients with inhibitors.
Condition | Intervention | Phase |
---|---|---|
Haemophilia |
Drug: activated recombinant human factor VII |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | High Dose Versus Standard Multiple Doses of Activated Recombinant Human Factor VII for Treatment of Mild/Moderate Joint Bleeds in Haemophilia Patients With Inhibitors |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |
Paris, France, 75015 | |
Hungary | |
Budapest, Hungary, 1135 | |
Israel | |
Tel-Hashomer, Israel, 52621 | |
Spain | |
Madrid, Spain, 28046 | |
Turkey | |
Capa-ISTANBUL, Turkey, 35100 | |
United Kingdom | |
Birmingham, United Kingdom, B15 2TH |
Study Director: | Peter Schelde, MSc | Novo Nordisk |
Responsible Party: | Novo Nordisk A/S ( Public Access to Clinical Trials ) |
Study ID Numbers: | F7HEAM-1510 |
Study First Received: | December 11, 2007 |
Last Updated: | November 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00571584 |
Health Authority: | Spain: Spanish Agency of Medicines; France: Afssaps - French Health Products Safety Agency; United Kingdom: Medicines and Healthcare Products Regulatory; Hungary: National Institute of Pharmacy; Israel: Israeli Health Ministry Pharmaceutical Administration; Turkey: Ministry of Health Drug and Pharmaceutical Department |
Hemorrhagic Disorders Genetic Diseases, Inborn Hematologic Diseases |
Blood Coagulation Disorders Hemophilia A Hemostatic Disorders |
Blood Coagulation Disorders, Inherited Coagulation Protein Disorders |