Observational Study on the Efficacy and Safety of NovoSeven® During "Real-life" Usage in Germany (WIRK)
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Purpose
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 |
|---|---|
|
Congenital Bleeding Disorder Congenital FVII Deficiency Glanzmann's Disease Acquired Bleeding Disorder Acquired Haemophilia |
Drug: activated recombinant human factor VII |
| Study Type: | Observational |
| Study Design: | Time Perspective: 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 |
- Proportion of acute bleeding episodes for which haemostasis (defined as stop or significant reduction of bleeding) will be achieved [ Time Frame: within 9 hours after initiation of treatment with NovoSeven® or of invasive procedures for which haemostasis will be maintained during the time period of haemostatic coverage with NovoSeven® ] [ Designated as safety issue: No ]
- Time proportion of acute bleeding treatments resulting in effective pain relief [ Time Frame: within 9 hours after initiation of treatment with NovoSeven® ] [ Designated as safety issue: Yes ]
- Proportion of patients experiencing one or more re-bleeds [ Time Frame: within 24 hours after begin of an acute bleeding episode that was successfully treated with NovoSeven® (stop or significant reduction of bleeding) ] [ Designated as safety issue: Yes ]
| Enrollment: | 68 |
| Study Start Date: | June 2008 |
| Study Completion Date: | December 2010 |
| 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 Other Names:
|
Eligibility| 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:
- Written informed consent obtained from patient or patient's legally acceptable representative in which he agrees that the patient's pseudonymised personal data will be transferred for use in a scientific evaluation and publication
Exclusion Criteria:
- Due to the non-interventional observational character of the study, there are no exclusion criteria.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Novo Nordisk |
| ClinicalTrials.gov Identifier: | NCT00697320 History of Changes |
| Other Study ID Numbers: | F7HAEM-1921 |
| Study First Received: | June 11, 2008 |
| Last Updated: | June 26, 2012 |
| Health Authority: | Germany: Paul-Ehrlich-Institut |
Additional relevant MeSH terms:
|
Blood Coagulation Disorders Hemostatic Disorders Hemorrhagic Disorders Hemophilia A Hemorrhage Thrombasthenia Hematologic Diseases |
Vascular Diseases Cardiovascular Diseases Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Genetic Diseases, Inborn Pathologic Processes Blood Platelet Disorders |
ClinicalTrials.gov processed this record on May 16, 2013