Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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®) when undergoing surgery under normal clinical practice conditions.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| eptacog alpha users |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eptacog alfa (activated) | Drug | Safety and effectiveness data collection in connection with the use of eptacog alpha in daily clinical practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| Physician's assessment of the evaluation for efficacy: Amount of blood at surgery, condition of haemostasis after surgery or maintenance of cessation of bleed | Year 1 | |
| Physician's assessment of the evaluation for efficacy: Amount of blood at surgery, condition of haemostasis after surgery or maintenance of cessation of bleed | Year 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events (AEs), including serious adverse events (SAEs) | Year 1, Year 10 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Patients with haemophilia A and B with inhibitors who received NovoSeven® (eptacog alpha) as treatment when undergoing the surgery
Not provided
| 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 |
Not provided
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided