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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001444-21 | EudraCT Number | ||
| U1111-1129-1517 | Other Identifier | WHO |
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This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body) of four lots of turoctocog alfa (a human recombinant coagulation factor VIII (FVIII)) in subjects with haemophilia A.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lot A | Experimental | Each subject will receive two single doses of turocotocog alfa from two lots of trial product on two separate days. |
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| Lot B | Experimental | Each subject will receive two single doses of turocotocog alfa from two lots of trial product on two separate days. |
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| Lot C | Experimental | Each subject will receive two single doses of turocotocog alfa from two lots of trial product on two separate days. |
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| Lot D | Experimental | Each subject will receive two single doses of turocotocog alfa from two lots of trial product on two separate days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| turoctocog alfa | Drug | Trial product, 2000 IU/vial will be administered as an i.v. (intravenous) bolus injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose normalised area under the curve (AUC/actual dose) based on chromogenic assay | up to 48 hours after i.v. administration |
| Measure | Description | Time Frame |
|---|---|---|
| Dose normalised area under the FVIII activity-time curve (AUC/actual dose) based on one stage clot assay | up to 48 hours after i.v. administration | |
| Incremental recovery (IR30min) (defined as the peak FVIII level recorded 30 min after injection and reported as[IU/mL]/[IU/kg]) |
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Inclusion Criteria:
Exclusion Criteria:
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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 | Berlin | 10249 | Germany | |||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25495795 | Result | Jimenez-Yuste V, Lejniece S, Klamroth R, Suzuki T, Santagostino E, Karim FA, Saugstrup T, Moss J. The pharmacokinetics of a B-domain truncated recombinant factor VIII, turoctocog alfa (NovoEight(R)), in patients with hemophilia A. J Thromb Haemost. 2015 Mar;13(3):370-9. doi: 10.1111/jth.12816. Epub 2015 Feb 13. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C577506 | recombinant factor VIII N8 |
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| turoctocog alfa | Drug | Trial product, 3000 IU/vial will be administered as an i.v. (intravenous) bolus injection. |
|
| up to 48 hours after i.v. administration |
| Area under the FVIII activity-time curve (AUC) | up to 48 hours after i.v. administration |
| Terminal half-life of FVIII (t½) | up to 48 hours after i.v. administration |
| Clearance of FVIII (CL) | up to 48 hours after i.v. administration |
| Incidence of adverse events (AEs) including FVIII inhibitors | After approximately 3 months (at end of trial) |
| Frankfurt/M. |
| 60590 |
| Germany |
| Novo Nordisk Investigational Site | Riga | 1006 | Latvia |
| Novo Nordisk Investigational Site | Kuala Lumpur | 50400 | Malaysia |
| Novo Nordisk Investigational Site | Madrid | 28046 | Spain |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |