Observational Study on the Efficacy and Safety of NovoSeven® During "Real-life" Usage in Germany (WIRK)
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ClinicalTrials.gov Identifier: NCT00697320 |
Recruitment Status
:
Completed
First Posted
: June 13, 2008
Last Update Posted
: December 7, 2016
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Condition or disease | Intervention/treatment |
---|---|
Congenital Bleeding Disorder Congenital FVII Deficiency Glanzmann's Disease Acquired Bleeding Disorder Acquired Haemophilia | Drug: eptacog alfa (activated) |
Study Type : | Observational |
Actual Enrollment : | 64 participants |
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 |
Study Start Date : | June 2008 |
Actual Primary Completion Date : | December 2010 |
Actual Study Completion Date : | December 2010 |

Group/Cohort | Intervention/treatment |
---|---|
A |
Drug: eptacog alfa (activated)
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:
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- 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® ]
- Time proportion of acute bleeding treatments resulting in effective pain relief [ Time Frame: within 9 hours after initiation of treatment with NovoSeven® ]
- 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) ]

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00697320
Germany | |
Novo Nordisk Investigational Site | |
Mainz, Germany, 55127 |
Study Director: | Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S |
Additional Information:
Responsible Party: | Novo Nordisk A/S |
ClinicalTrials.gov Identifier: | NCT00697320 History of Changes |
Other Study ID Numbers: |
F7HAEM-1921 |
First Posted: | June 13, 2008 Key Record Dates |
Last Update Posted: | December 7, 2016 |
Last Verified: | December 2016 |
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 |