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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003163-63 | EudraCT Number | ||
| U1111-1145-6620 | Other Identifier | WHO |
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This trial is conducted in Europe. The aim of the trial is to investigate the bioequivalence of eptacog alfa A 6 mg and NovoSeven® in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NovoSeven® | Active Comparator |
| |
| Eptacog alfa A 6 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| activated recombinant human factor VII | Drug | All subjects will receive one i.v. (intravenous, into the vein) injection of 90μg/kg. Each subject will be allocated to two treatment periods separated by a wash-out period of a week. |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve | After a single i.v. injection based on FVIIa activity assessments up to 36 hours post dose | |
| Maximum concentration | After a single i.v. injection based on FVIIa activity assessments up to 36 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of adverse events (including serious adverse events) | Assessed up to 7 weeks following first trial product administration | |
| Incidence of antibodies | Assessed up to 7 weeks following first trial product administration |
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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 |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| eptacog alfa (activated) | Drug | All subjects will receive one i.v. injection of 90μg/kg. Each subject will be allocated to two treatment periods separated by a wash-out period of a week. |
|
| 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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