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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1116-1529 | Other Identifier | WHO |
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This study is conducted in Japan. The aim of this observational study is to evaluate the long-term safety and efficacy of activated recombinant human factor VII (NovoSeven®) in subjects with congenital FVII deficiency.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| activated recombinant human factor VII | Drug | Data will be collected at the baseline visit and approximately once a year until end of study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Presence and/or the appearance of inhibiting antibodies to factor VII and/or therapy-related thrombosis on using NovoSeven® under normal clinical practice conditions | once a year in years 1-4 |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the treatment evaluation for bleeding episodes | year 1, year 4 | |
| To assess the course and outcome of pregnancy in women treated with novoseven | until 1 month after giving birth |
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Inclusion Criteria:
Exclusion Criteria:
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All subjects with a FVII deficiency to whom activated recombinant human factor VII (NovoSeven®) is administered
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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 |
|---|---|---|---|---|---|---|
| Tokyo | 1000005 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37395185 | Derived | Seita I, Kinai E. A multicenter, observational study to evaluate hemostasis following recombinant activated FVII treatment in patients in Japan with congenital factor VII deficiency. Blood Coagul Fibrinolysis. 2023 Jul 1;34(5):295-304. doi: 10.1097/MBC.0000000000001225. Epub 2023 Jun 23. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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