Table 1 Clinical studies with drotrecogin alfa (activated) in adult patients with severe sepsis
Study ID | Study descriptor | Dosage and administration | Status |
|---|---|---|---|
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 |