NCT00386425

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

A Phase 2 Study to Evaluate Dose and Duration of Treatment of Drotrecogin Alfa (Activated) Using Serial Measurements of Protein C in Patients With Severe Sepsis and Multiple Organ Dysfunction

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 486 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Severe Sepsis

Interventions

Type	Name	Description
DRUG	Drotrecogin alfa (activated)	intravenous

Timeline

• Start date: 2006-11-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2006-10-11
• Last updated: 2010-12-16
• Results posted: 2010-12-16

Locations

47 sites across 9 countries: United States, Belgium, Canada, Finland, France, Germany, Puerto Rico, Spain, United Kingdom