Table 1 |
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Clinical studies with drotrecogin alfa (activated) in adult patients with severe sepsis |
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| Study ID |
Study descriptor |
Dosage and administration |
Status |
|
|
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| F1K-MC-EVAA (n = 90) |
A phase 2 dose-ranging study |
12, 18, 24, 30 μg/kg per hour for 48 hours; 12, 18, 24 μg/kg per hour for 96 hours |
Completed |
| F1K-MC-EVAD (n = 850) |
A phase 3 efficacy study (PROWESS) |
24 μg/kg per hour for 96 hours (± 1 hour). |
Completed |
| F1K-MC-EVAS (n = 28) |
A compassionate-use study in purpura fulminans |
24 μg/kg per hour for a minimum of 96 hours |
Completed |
| F1K-MC-EVBE (n = 273) |
An open-label study (ENHANCE) |
24 μg/kg per hour for 96 hours (± 1 hour) |
Completed |
| F1K-MC-EVBF (n = 1189) |
An open-label study (ENHANCE) |
24 μg/kg per hour for 96 hours (± 1 hour) |
Ongoing |
| F1K-MC-EVBG (n = 116) |
An open-label study (ENHANCE) |
24 μg/kg per hour for 96 hours (± 1 hour) |
Ongoing |
| F1K-MC-EVBC (n = 240)1 |
A compassionate-use study |
24 μg/kg per hour for 96 hours (± 1 hour) |
Ongoing |
|
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Source: clinical study reports for completed studies and protocols for ongoing studies. 1Mortality and safety monitored for 7 days in countries outside the USA. PROWESS, Recombinant Human Activated Protein C Worldwide Evaluation in Severe Sepsis; ENHANCE, Extended Evaluation of Recombinant Human Activated Protein C. |
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Bernard et al. Critical Care 2003 7:155 doi:10.1186/cc2167 |
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