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This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the efficacy of activated recombinant human factor VII to mitigate experimentally-induced bleeding in healthy volunteers treated with warfarin to reach a targeted INR (International Normalization Ratio).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-warfarin treatment (trial part A) | Experimental |
| |
| Post-warfarin treatment (trial part B) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| warfarin | Drug | After a baseline punch biopsy (B0), warfarin is administered over a period of approximately 7-14 days. Dose is adjusted individually to achieve INR target. Once a stable INR is achieved, a second biopsy (B1) will be performed |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding duration measured in minutes after biopsies in trial part A | From onset of bleeding till the end of the bleeding | |
| Bleeding duration measured in minutes after biopsy B1 in trial part B | From onset of bleeding till the end of the bleeding |
| Measure | Description | Time Frame |
|---|---|---|
| Blood volume reported in millilitres after biopsies in trial part A | From onset of bleeding till the end of the bleeding | |
| Blood volume reported in millilitres after biopsy B1 in trial part B | From onset of bleeding till the end of the bleeding |
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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 | Overland Park | Kansas | 66211 | United States |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| ID | Term |
|---|---|
| D014859 | Warfarin |
| D005167 | Factor VII |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 |
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| eptacog alfa (activated) | Drug | If the subject is eligible to continue in trial part B, trial drug will be administered i.v. as a slow bolus injection over 2 to 5 minutes in five different doses followed by two biopsies (B2) and (B3) 15 minutes and 5 hours and 15 minutes, respectively, after trial drug administration |
|
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| placebo | Drug | If the subject is eligible to continue in trial part B, trial drug will be administered i.v. as a slow bolus injection over 2 to 5 minutes in five different doses followed by two biopsies (B2) and (B3) 15 minutes and 5 hours and 15 minutes, respectively, after trial drug administration |
|
| Adverse events, including thrombotic events | From day 0 to days 14-28 |
| Change in coagulation-related parameters after biopsy B1 | From baseline to 3 hours after B1 |
| 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 3 hours after B3 |
| Clot dynamics: R in minutes (trial part B) | Time to onset of clot formation |
| Clot dynamics: K in minutes (trial part B) | Time to achieve 20mm clot strength |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| 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 |