Evaluate Protein C Levels in Severe Sepsis Patients on Drotrecogin Alfa (Activated)

Completed · Phase 2

Conditions studied: Severe Sepsis

In brief

In this trial, patients with severe sepsis and low protein C levels will receive drotrecogin alfa (activated) at the normal, approved dose and time of administration \[24 microgram/kilogram/hour (mcg/kg/hour) for 96 hours\] or will receive the normal, approved dose or higher doses than the approved dose for a longer administration time. After the drug administration is complete, the protein C levels from the patients receiving the normal, approved dose will be compared to protein C levels from patients receiving the normal, approved dose or higher dose for a longer duration to determine if the protein C levels improve faster if given higher dose and/or longer administration time. Note: The protocol was amended to remove the option of shorter infusion durations.

Key facts

Study ID
NCT00386425
Run by
Eli Lilly and Company
People needed
486
Starts
2006-11-01
Expected to finish
2009-08-01
Last updated by the study team
2010-12-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

You may not qualify if…

Where it is running

Full record on ClinicalTrials.gov

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