Phase 2
N=486
Evaluate Protein C Levels in Severe Sepsis Patients on Drotrecogin Alfa (Activated)
Severe Sepsis
Bottom Line
View on ClinicalTrials.gov: NCT00386425 ↗Enrolled (actual)
486
Serious AEs
16.7%
Results posted
Dec 2010
Primary outcome: Primary: Mean Change in Protein C Levels From Day 1 to Day 7 — 55; 52; 79; 83 Percent Protein C Activity — p=0.011
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Drotrecogin alfa (activated) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Protein C Levels From Day 1 to Day 7 |
55; 52; 79; 83; 24; 31 | 0.011 sig |
| SECONDARY Mean Change in Protein C Level From Study Day 1 to Study Day 7 in Patients With Moderate and Severe Protein C Deficiency |
24; 30; 25; 38 | 0.047 sig |
| SECONDARY Day 28 All-Cause Mortality |
83.9; 75.1; 16.1; 24.9 | 0.030 sig |
| SECONDARY Hospital Mortality (up to Day 90) |
79.5; 72.2; 20.5; 27.8 | 0.090 |
| SECONDARY 28-Day Time Averaged Sequential Organ Failure (SOFA) Score |
5.96; 6.62; 1.28; 1.41; 2.22; 2.38 | 0.190 |
| SECONDARY Number of Participants With Serious Adverse Events (SAE) and Serious Bleeding Events (SBE) by Time Period |
0; 2; 0; 9; 1; 0 | — |
| SECONDARY Mortality by Protein C Normalized Versus Not-normalized |
10.3; 32.0 | <0.0001 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older
- Must have a suspected or proven infection
- Must have two or more sepsis-associated organ dysfunctions
Exclusion Criteria
- Documented multiple organ dysfunction greater than 24 hours prior to start of study drug
- Actual body weight less than 30 kg or more than 135 kg
- Platelet count less than 30,000/mm^3
- Active internal bleeding or at increased risk of bleeding
- Not expected to survive 28 days given the patient's pre-existing uncorrectable medical condition
Data sourced from ClinicalTrials.gov (NCT00386425). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.