Observational Study on the Efficacy and Safety of NovoSeven® During "Real-life" Usage in Germany (WIRK)
This study has been completed.
Sponsor:
Novo Nordisk A/S
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00697320
First received: June 11, 2008
Last updated: August 8, 2014
Last verified: August 2014
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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 |
Resource links provided by NLM:
Genetic and Rare Diseases Information Center resources:
Hemophilia
Acquired Hemophilia
Thrombasthenia
Glanzmann Thrombasthenia
Hemophilia A
U.S. FDA Resources
Further study details as provided by Novo Nordisk A/S:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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: | 64 |
| 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| Ages Eligible for Study: | Child, Adult, Senior |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
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®.
Criteria
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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00697320
Please refer to this study by its ClinicalTrials.gov identifier: NCT00697320
Locations
| Germany | |
| Mainz, Germany, 55127 | |
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
| Study Director: | Peter Lampen, PhD | Novo Nordisk Pharma GmbH |
More Information
Additional Information:
| ClinicalTrials.gov Identifier: | NCT00697320 History of Changes |
| Other Study ID Numbers: | F7HAEM-1921 |
| Study First Received: | June 11, 2008 |
| Last Updated: | August 8, 2014 |
| Health Authority: | Germany: Paul-Ehrlich-Institut |
Additional relevant MeSH terms:
|
Disease Hemorrhage Hemophilia A Blood Coagulation Disorders Hemostatic Disorders Hemorrhagic Disorders Thrombasthenia Pathologic Processes |
Blood Coagulation Disorders, Inherited Hematologic Diseases Coagulation Protein Disorders Genetic Diseases, Inborn Vascular Diseases Cardiovascular Diseases Blood Platelet Disorders |
ClinicalTrials.gov processed this record on September 23, 2016