Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2015-005327-63 | EudraCT Number | ||
| U1111-1176-9253 | Other Identifier | WHO |
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
Investigating single dose pharmacokinetics and safety of turoctocog alfa pegol from the pivotal process and turoctocog alfa pegol from the commercial process in patients with severe haemophilia A
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N8-GP pivotal | Experimental |
| |
| N8-GP commercial | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| turoctocog alfa pegol | Drug | Administered as intravenous injections at a dose of 50 U/kg. Patients will receive each product in a randomised cross-over design for comparison of the pharmacokinetics between turoctocog alfa pegol from the pivotal process and turoctocog alfa pegol from the commercial process. |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the FVIII activity-time curve | From 0 to 96 hours post injection |
| Measure | Description | Time Frame |
|---|---|---|
| FVIII activity 30 min post administration - dose normalised to 50 U/kg | From time of trial product administration to 96 hours post-dose | |
| Area under the FVIII activity-time curve from 0 to infinity | From time of trial product administration to 96 hours post-dose |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Torrance | California | 90502-2004 | United States | ||
| Novo Nordisk Investigational Site |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Clearance in blood plasma of FVIII activity | From time of trial product administration to 96 hours post-dose |
| Incremental recovery in blood plasma of FVIII activity | From time of trial product administration to 96 hours post-dose |
| Terminal half-life | From time of trial product administration to 96 hours post-dose |
| Iowa City |
| Iowa |
| 52242 |
| United States |
| Novo Nordisk Investigational Site | Baltimore | Maryland | 21287 | United States |
| Novo Nordisk Investigational Site | Dayton | Ohio | 45404 | United States |
| Novo Nordisk Investigational Site | Nashville | Tennessee | 37232 | United States |
| Novo Nordisk Investigational Site | Århus N | 8200 | Denmark |
| Novo Nordisk Investigational Site | Bron | 69677 | France |
| Novo Nordisk Investigational Site | Nantes | 44093 | France |
| Novo Nordisk Investigational Site | Berlin | 10249 | Germany |
| Novo Nordisk Investigational Site | Frankfurt/M. | 60590 | Germany |
| Novo Nordisk Investigational Site | Homburg | 66421 | Germany |
| Novo Nordisk Investigational Site | Groningen | 9713 GZ | Netherlands |
| Novo Nordisk Investigational Site | Madrid | 28046 | Spain |
| Novo Nordisk Investigational Site | Málaga | 29010 | Spain |
| 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 |
Not provided
Not provided