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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1126-0353 | Other Identifier | WHO | |
| ENCEPP/SDPP/5501 | Registry Identifier | EU PAS |
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This study is conducted in Europe, and North and South America. The aim of this study is to provide additional documentation of the immunogenicity, and obtain additional clinical data, of turoctocog alfa in the setting of normal clinical practise in patients previously treated with a factor VIII agent (FVIII).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| turoctocog alfa | Drug | Patients will be treated with commercially available turoctocog alfa as prescribed by the treating physician in clinical daily practice and preferably according to the label for turoctocog alfa in the respective countries. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of FVIII inhibitors (at least 0.6 Bethesda Units (BU) for central laboratory analyses, or above the specific local laboratory reference range) represented as the percentage of patients developing inhibitors | Within approximately 7 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse reactions reported | During approximately 7 years | |
| Number of serious adverse reactions reported | During approximately 7 years | |
| Haemostatic effect of turoctocog alfa in the treatment of bleeds as assessed by the patient or the physician according to a predefined four point scale: Excellent, Good, Moderate, or None |
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Inclusion Criteria:
Exclusion Criteria:
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Previously FVIII treated (more than 150 exposure days) patients with severe and moderately severe haemophilia A with FVIII below or equal to 2%.
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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 | Mobile | Alabama | 36604 | United States | ||
| Novo Nordisk Investigational Site |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| Within approximately 7 years |
| Haemostatic effect of turoctocog alfa during surgical procedures as assessed by an evaluation according to a predefined four point scale: Excellent, Good, Moderate, or None | Within approximately 7 years |
| Annualised bleeding rate for patients using turoctocog alfa for preventive treatment | Within approximately 7 years |
| Annualised bleeding rate for patients using turoctocog alfa for on-demand treatment | Within approximately 7 years |
| Torrance |
| California |
| 90502-2004 |
| United States |
| Novo Nordisk Investigational Site | Peoria | Illinois | 61615 | United States |
| Novo Nordisk Investigational Site | Albuquerque | New Mexico | 87106 | United States |
| Novo Nordisk Investigational Site | Charlotte | North Carolina | 28203 | United States |
| Novo Nordisk Investigational Site | Salt Lake City | Utah | 84113 | United States |
| Novo Nordisk Investigational Site | Graz | 8036 | Austria |
| Novo Nordisk Investigational Site | Linz | 4020 | Austria |
| Novo Nordisk Investigational Site | Brno | 625 00 | Czechia |
| Novo Nordisk Investigational Site | Bordeaux | 33076 | France |
| Novo Nordisk Investigational Site | Montmorency | 95160 | France |
| Novo Nordisk Investigational Site | Rennes | 35033 | France |
| Novo Nordisk Investigational Site | Saint-Etienne | 42055 | France |
| Novo Nordisk Investigational Site | Strasbourg | 67098 | France |
| Novo Nordisk Investigational Site | Braunschweig | 38118 | Germany |
| Novo Nordisk Investigational Site | Duisburg | 47051 | Germany |
| Novo Nordisk Investigational Site | Frankfurt am Main | 60596 | Germany |
| Novo Nordisk Investigational Site | Giessen | 35392 | Germany |
| Novo Nordisk Investigational Site | Leipzig | 04289 | Germany |
| Novo Nordisk Investigational Site | Mörfelden-Walldorf | 64546 | Germany |
| Novo Nordisk Investigational Site | München | 80331 | Germany |
| Novo Nordisk Investigational Site | Münster | 48143 | Germany |
| Novo Nordisk Investigational Site | Athens | GR-11527 | Greece |
| Novo Nordisk Investigational Site | Budapest | H-1134 | Hungary |
| Novo Nordisk Investigational Site | Debrecen | 4032 | Hungary |
| Novo Nordisk Investigational Site | Mohács | 7700 | Hungary |
| Novo Nordisk Investigational Site | Castelfranco Veneto | 31033 | Italy |
| Novo Nordisk Investigational Site | Catania | 95123 | Italy |
| Novo Nordisk Investigational Site | Florence | 50134 | Italy |
| Novo Nordisk Investigational Site | Padova | 35128 | Italy |
| Novo Nordisk Investigational Site | Palermo | 90127 | Italy |
| Novo Nordisk Investigational Site | The Hague | 2545AA | Netherlands |
| Novo Nordisk Investigational Site | Utrecht | 3584 CX | Netherlands |
| Novo Nordisk Investigational Site | Warsaw | 02-091 | Poland |
| Novo Nordisk Investigational Site | Banská Bystrica | 975 17 | Slovakia |
| Novo Nordisk Investigational Site | Košice | 04001 | Slovakia |
| Novo Nordisk Investigational Site | Ljubljana | 1000 | Slovenia |
| Novo Nordisk Investigational Site | Barcelona | 08035 | Spain |
| Novo Nordisk Investigational Site | Malmö | 205 02 | Sweden |
| Novo Nordisk Investigational Site | Stockholm | 171 76 | Sweden |
| Novo Nordisk Investigational Site | Zurich | 8091 | Switzerland |
| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| 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 |
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| ID | Term |
|---|---|
| C577506 | recombinant factor VIII N8 |
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