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Sponsored by: |
Novo Nordisk |
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Information provided by: | Novo Nordisk |
ClinicalTrials.gov Identifier: | NCT00703911 |
This study is conducted in Europe.
The primary objective of this registry is to observe the use of single dose and multi-dose use of NovoSeven® and to compare short-term outcomes, including effectiveness, safety, quality of life and treatment satisfaction with the approved treatments.
Condition | Intervention |
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Haemophilia A Haemophilia B |
Drug: activated recombinant human factor VII |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Efficacy and Safety of NovoSeven® (Activated Recombinant Human Factor VII) Used as on-Demand Treatment of Mild to Moderate Bleeds in Patients With Haemophilia A and B With Inhibitors |
Estimated Enrollment: | 60 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
---|---|
A |
Drug: activated recombinant human factor VII
Treatment of patients experiencing bleeds at the discretion of the physician/caregiver.
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Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Haemophilia A and B patients with inhibitors, using NovoSeven® as on-demand treatment
Inclusion Criteria:
Exclusion Criteria:
Contact: Public Access to Clinical Trials - Novo Nordisk | Please Contact NN via email | clinicaltrials@novonordisk.com |
Study Director: | Paulo André Palhares de Miranda | Novo Nordisk Health Care AG |
Responsible Party: | Novo Nordisk A/S ( Public Access to Clinical Trials ) |
Study ID Numbers: | F7HAEM-3507 |
Study First Received: | June 19, 2008 |
Last Updated: | October 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00703911 |
Health Authority: | Poland: Office for Reg Med Prod, Devices, Biocidal Prod, Central Reg CT; Netherlands: The Central Committee on Research Involving Human Subjects (CCM; Spain: Spanish Agency of Medicines |
Haemophilia A or B with inhibitors |
Hemophilia B Hemorrhagic Disorders Genetic Diseases, Inborn Hematologic Diseases |
Blood Coagulation Disorders Hemophilia A Genetic Diseases, X-Linked Hemostatic Disorders |
Blood Coagulation Disorders, Inherited Coagulation Protein Disorders |