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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1116-2012 | Other Identifier | WHO |
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This study is conducted in Europe and Asia. The aim of this observational study is to monitor antibody formation towards the room temperature stable formulation of NovoSeven® (activated recombinant human factor VII).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| activated recombinant human factor VII | Drug | Administration of room temperature stable NovoSeven® (activated recombinant human factor VII) in dosages prescribed by the treating physician according to the product labelling text approved in his country. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduced therapeutic response and neutralising antibodies to activated recombinant human factor VII as confirmed by central laboratory | after 25 exposure days |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events reported as potentially related to activated recombinant human factor VII | after 25 exposure days |
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Inclusion Criteria:
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Male patients with haemophilia A or B with inhibitors treated with room temperature stable NovoSeven® (activated recombinant human factor VII).
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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 |
|---|---|---|---|---|---|---|
| Prov. de Buenos Aires | B1636DSU | Argentina | ||||
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| Vienna |
| A-1010 |
| Austria |
| Brussels | 1070 | Belgium |
| Paris La Défense Cedex | 92932 | France |
| Mainz | 55127 | Germany |
| Budapest | 1025 | Hungary |
| Tehran | Iran |
| Dublin | Ireland |
| Rome | 00144 | Italy |
| Warsaw | PL-02-274 | Poland |
| Paço de Arcos | 2780-730 | Portugal |
| Bratislava | 811 05 | Slovakia |
| Malmö | 202 15 | Sweden |
| Crawley | RH11 9RT | United Kingdom |
| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| D002836 | Hemophilia B |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D040181 | Genetic Diseases, X-Linked |
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