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Sponsored by: |
Novo Nordisk |
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Information provided by: | Novo Nordisk |
ClinicalTrials.gov Identifier: | NCT00697320 |
This NON INTERVENTIONAL OBSERVATIONAL STUDY is conducted in Europe. The primary aim is to observe the haemostatic efficacy of NovoSeven® treatment during routine practice in German clinics. The observational study observes patients with congenital haemophilia with inhibitors to coagulation factors VIII or IX, acquired haemophilia, congenital FVII deficiency, or Glanzmann's thrombasthenia who have received at least one dose of NovoSeven® for treatment of a bleeding episode or for the prevention of a bleeding when undergoing surgery or an invasive procedure.
Condition | Intervention |
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Haemophilia |
Drug: activated recombinant human factor VII |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Efficacy of NovoSeven® (Activated Recombinant Human Factor VII): Non-Interventional Study in Patients With Congenital Haemophilia With Inhibitors, Acquired Haemophilia, Factor FVII Deficiency, and Glanzmann's Thrombasthenia |
Estimated Enrollment: | 100 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
---|---|
A |
Drug: activated recombinant human factor VII
A NON INTERVENTIONAL OBSERVATIONAL STUDY: Doses and frequency of injections to be prescribed by the physician as a result of the normal clinical evaluation |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients with congenital haemophilia with inhibitors to coagulation factors VIII or IX, acquired haemophilia, congenital FVII deficiency, or Glanzmann's thrombasthenia who have received at least one dose of NovoSeven®
Inclusion Criteria:
Exclusion Criteria:
Contact: Public Access to Clinical Trials - Novo Nordisk | Please Contact NN via email | clinicaltrials@novonordisk.com |
Germany | |
Recruiting | |
Mainz, Germany, 55127 |
Study Director: | Peter Lampen, PhD | Novo Nordisk Pharma GmbH |
Responsible Party: | Novo Nordisk A/S ( Public Access to Clinical Trials ) |
Study ID Numbers: | F7HAEM-1921 |
Study First Received: | June 11, 2008 |
Last Updated: | December 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00697320 |
Health Authority: | Germany: Paul-Ehrlich-Institut |
Thrombocytopathy Thrombasthenia of Glanzmann and Naegeli Hemorrhagic Disorders Genetic Diseases, Inborn Hematologic Diseases |
Blood Platelet Disorders Blood Coagulation Disorders Hemophilia A Thrombasthenia Hemostatic Disorders |
Blood Coagulation Disorders, Inherited Coagulation Protein Disorders |