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This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to evaluate the basal and spiked TEG® (Thromboelastography) or ROTEM® (Thromboelastometry) profiles of frequently bleeding haemophilia subjects with inhibitors in a non-bleeding state.
The TEG parameters are: R time (Reaction Time), K time (K Time (arbitrary measurement)), a (a angle), MA (Maximum Amplitude) and LY30 (Lysis 30 min after MA) while the ROTEM parameters are: CT (Clotting Time), CFT (Clot Formation Time), a (a angle), MCF (Maximum Clot Firmness) and LI60 (Lysis index 60 min after CT)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ex vivo | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eptacog alfa (activated) | Drug | Subjects will be called to attend the clinic in a non-bleeding state. Blood samples will be drawn for thromboelastogram profiling and will be in-vitro spiked with different doses of activatated recombinant human factor VII. |
| Measure | Description | Time Frame |
|---|---|---|
| TEG parameters obtained at baseline and with activated recombinant human factor VII | ||
| ROTEM parameters obtained at baseline and with activated recombinant human factor VII |
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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 | Berkeley | California | 94704 | United States | ||
| Novo Nordisk Investigational Site |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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|
| Los Angeles |
| California |
| 90027 |
| United States |
| Novo Nordisk Investigational Site | Iowa City | Iowa | 52242 | United States |
| Novo Nordisk Investigational Site | Philadelphia | Pennsylvania | 19104 | United States |
| Novo Nordisk Investigational Site | Ã…rhus N | 8200 | Denmark |
| Novo Nordisk Investigational Site | Lyon | 69003 | France |
| Novo Nordisk Investigational Site | London | E1 2AD | United Kingdom |
| 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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