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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000040-26 | EudraCT Number | ||
| U1111-1138-2521 | 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) and pharmacodynamics (the effect of the investigated drug on the body) of rFVIIa (activated coagulation factor VII) following one single injection of 270 microg/kg compared to three injections of 90 microg/kg rFVIIa in patients with haemophilia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 270 microg/kg rFVIIa | Active Comparator | Each subject will receive one single injection of 270 microg/kg and three injections of 90 microg/kg rFVIIa (one injection every 3 hours) in a randomised order. The two administration days will be separated by a wash-out period of at least 48 hours |
|
| 3x90 microg/kg rFVIIa | Active Comparator | Each subject will receive one single injection of 270 microg/kg and three injections of 90 microg/kg rFVIIa (one injection every 3 hours) in a randomised order. The two administration days will be separated by a wash-out period of at least 48 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eptacog alfa (activated) | Drug | Subject will receive a single injection (i.v.) of 270 microg/kg rFVIIa (NovoSeven®) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Thromboelastography (TEG) parameter Maximum Thrombosis Generation (MTG;'maximum velocity') | 10 minutes post-dose for 270 microg/kg and 10 minutes after the first injection of 90 microg/kg |
| Measure | Description | Time Frame |
|---|---|---|
| TEG parameters r-time, MTG, alpha angle, and maximum amplitude (MA) | Prior to and 24 hours following the administrtion of 270 microg/kg and each of the 3 administrations of 90 microg/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 |
|---|---|---|---|---|---|---|
| Madrid | 28046 | Spain |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| eptacog alfa (activated) | Drug | Subject will receive 3 injections (i.v.) of 90 microg/kg rFVIIa (NovoSeven®) over a 6 hour period (each injection will be separated by 3 hours) |
|
| 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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| ID | Term |
|---|---|
| D005167 | Factor VII |
| ID | Term |
|---|---|
| D004792 | Enzyme Precursors |
| D045762 | Enzymes and Coenzymes |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
| D001685 | Biological Factors |
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