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This study is conducted in Japan. The aim of this non-interventional study is to investigate the safety and effectiveness of treatment with eptacog alpha (NovoSeven®) under normal clinical practice conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| eptacog alpha users |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eptacog alfa (activated) | Drug | Prescription of eptacog alpha at the discretion of the physician |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of bleed treatments resulting in effective bleed resolution: Markedly effective, effective, moderate or ineffective | Year 1 | |
| Percentage of bleed treatments resulting in effective bleed resolution: Markedly effective, effective, moderate or ineffective | Year 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events (AEs), including serious adverse events (SAEs) | Baseline, every 1 year, Year 10 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with haemophilia A and B with inhibitors who received NovoSeven® (eptacog alpha)
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Tokyo | 1000005 | Japan |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| ID | Term |
|---|---|
| D005167 | Factor VII |
| ID | Term |
|---|---|
| D004792 | Enzyme Precursors |
| D045762 | Enzymes and Coenzymes |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
| D001685 | Biological Factors |
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