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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-004379-56 | EudraCT Number | ||
| U1111-1175-1191 | Other Identifier | WHO |
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This trial is conducted globally. The aim of this trial is evaluating the pharmacokinetics (the exposure of the trial drug in the body) of NovoEight® (turoctocog alfa) in relation to BMI (body mass index) in subjects with haemophilia A.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Turoctocog alfa | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| turoctocog alfa | Drug | Each subject will receive a single dose of turoctocog alfa as an intravenous (i.v.) bolus injection of 50 IU/kg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma FVIII activity at 30 minutes(C30min) | Based on samples taken at pre-dose (-1hour), 15minutes, 30minutes, 1hour, 3hours, 6hours, 9hours, 24hours, 28hours, 48hours, 72hours post-dose | At 30 minutes post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the FVIII activity-time curve | From 0 up to 72 hours after administration | |
| Incremental recovery FVIII at 30 minutes (IR30min) | Based on samples taken at pre-dose (-1hour), 15minutes, 30minutes, 1hour, 3hours, 6hours, 9hours, 24hours, 28hours, 48hours, 72hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Chicago | Illinois | 60612 | United States | ||
| Novo Nordisk Investigational Site |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| At 30 minutes post-dose |
| Terminal half-life (t½) of FVIII | From 0 up to 72 hours after administration |
| Clearance (CL) of FVIII | From 0 up to 72 hours after administration |
| Apparent volume of distribution at steady state (Vss) of FVIII | From 0 up to 72 hours after administration |
| Peoria |
| Illinois |
| 61615 |
| United States |
| Novo Nordisk Investigational Site | Memphis | Tennessee | 38104 | United States |
| Novo Nordisk Investigational Site | Richmond | Virginia | 23298 | United States |
| Novo Nordisk Investigational Site | Vienna | 1090 | Austria |
| Novo Nordisk Investigational Site | Sofia | 1756 | Bulgaria |
| Novo Nordisk Investigational Site | Bonn | 53127 | Germany |
| Novo Nordisk Investigational Site | Hanover | 30625 | Germany |
| Novo Nordisk Investigational Site | Belgrade | 11000 | Serbia |
| Novo Nordisk Investigational Site | Madrid | 28046 | Spain |
| Novo Nordisk Investigational Site | Málaga | 29010 | Spain |
| Novo Nordisk Investigational Site | Valencia | 46026 | Spain |
| Novo Nordisk Investigational Site | Vigo | 36312 | Spain |
| Novo Nordisk Investigational Site | Changhua | 500 | Taiwan |
| Novo Nordisk Investigational Site | Taipei | 100 | Taiwan |
| 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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