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| Name | Class |
|---|---|
| PRA Health Sciences | INDUSTRY |
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This is a randomized, open label, placebo-controlled, parallel design, single center, prospective study. Subjects will receive treatment with VKA. Subjects who reach the targeted INR, will receive single dose of Cofact. Multiple coagulation laboratory tests will be evaluated over a period of 15 days
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cofact Dose 1 | Experimental |
| |
| Cofact Dose 2 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cofact | Biological | Human prothrombin complex concentrate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak thrombin generation at 30 minutes after end of the Cofact infusion | 30 minutes post Cofact infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in ETP | Change in endogenous thrombin potential (ETP) over 24 hours after the EOI | 24 hours post Cofact infusion |
| Concentration in clotting factors | Changes in aPTT, PT, and INR |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Salah Hadi, MD | PRA Health Sciences | Principal Investigator |
| Thomas Bodewes, MD | Prothya Biosolutions | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA Health Sciences | Groningen | Netherlands |
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| ID | Term |
|---|---|
| C025667 | prothrombin complex concentrates |
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| up to Day 15 |
| Coagulation markers | Concentration over time of clotting factors: FII, FVII, FIX, FX, protein C, and protein S | up to Day 15 |
| Coagulation activation markers | Concentration over time of Prothrombin fragment 1+2, D-dimer, and thrombin-antithrombin complexes (TATs) | up to Day 15 |
| Safety outcome | Frequency and severity of adverse events (AEs) | up to Day 15 |