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This trial is conducted in the United States of the America (USA). The aim of this trial is to evaluate the effectiveness of activated recombinant human factor VII to mitigate experimentally-induced bleeding in healthy volunteers treated with clopidogrel (Plavix®).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Factor VII | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eptacog alfa (activated) | Drug | If subject is eligible to continue after clopidogrel treatment, three different doses of trial drug is administered i.v. as a slow bolus injection over two to three minutes followed by post-trial biopsies |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding duration measured in minutes | From onset of bleeding till the end of the bleeding |
| Measure | Description | Time Frame |
|---|---|---|
| Blood volume reported in millilitres | From onset of bleeding till the end of the bleeding | |
| Clot dynamics on the TEG (thromboelastograph hemostasis analyzer): R in minutes | Time to onset of clot formation |
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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 | Neptune City | New Jersey | 07753 | United States |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| ID | Term |
|---|---|
| D005167 | Factor VII |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D004792 | Enzyme Precursors |
| D045762 | Enzymes and Coenzymes |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
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|
| clopidogrel | Drug | Following a baseline biopsy (B0) subjects will receive oral treatment with an initial 300 mg loading dose followed by daily 75 mg doses for at least 3 additional days. If the target platelet inhibition (PI) is achieved, the subject will undergo punch biopsy 1 (B1). |
|
| placebo | Drug | If subject is eligible to continue after clopidogrel treatment, three different doses of trial drug is administered i.v. as a slow bolus injection over two to three minutes followed by post-trial biopsies |
|
| Clot dynamics on the TEG (thromboelastograph hemostasis analyzer): K in minutes | Time to achieve 20 mm clot strength |
| Adverse events, including thrombotic events | From screening to day 11-18 |
| Change in coagulation-related parameters after pre-biopsy | From baseline to 15 minutes after pre-biopsy |
| Change in coagulation-related parameters after biopsy B2 | From baseline to 3 hours after B2 |
| Change in coagulation-related parameters after biopsy B3 | From baseline to 1 hour after B3 |
| D011506 |
| Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
| D001685 | Biological Factors |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |