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NCT00386425 · ClinicalTrials.gov registry record · Phase 2
Evaluate Protein C Levels in Severe Sepsis Patients on Drotrecogin Alfa (Activated)
A Phase 2 study of Severe Sepsis, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 486
- Enrollment target
- 20
- Study locations
NCT00386425: Completed Phase 2 study of Severe Sepsis, sponsored by Eli Lilly and Company.
NCT00386425 is a Phase 2 study of Severe Sepsis that has completed, run by Eli Lilly and Company. The registered enrollment target is 486 participants, below the 6,157-participant average among 9 other Severe Sepsis trials with a reported enrollment target (92% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00386425, a Phase 2 study of Severe Sepsis, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 486 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Mean change in protein C from Study Day 1 to Study Day 7 was tested using an unadjusted two-sample t-test with a two-sided alpha of 0.05. To be included in the primary analysis, Intention-to-Treat (ITT) patients must have at least 1 protein C value available at 24 hours or earlier and at least 1 protein C value at a post-24-hour timepoint.
Conditions Studied
Interventions
- DRUG Drotrecogin alfa (activated)
Study Locations (20)
California
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Fresno
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Loma Linda
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Stanford
Arizona
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Phoenix
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Scottsdale
Other
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Brussels
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Ghent
District of Columbia
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Washington D.C.
Florida
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Orlando
Idaho
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Idaho Falls
Indiana
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Indianapolis
Kentucky
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 486 participants |
| Start Date | 2006-11 |
| Est. Completion | 2009-08 |
| Phase | Phase 2 |
What the finished NCT00386425 record still lists
NCT00386425 is an interventional study that assigns participants to a tested intervention. The registered 486 participants enrollment target is mid-sized for trials with a published cap, below the 6,157-participant average among 9 other Severe Sepsis trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Severe Sepsis appearing as the primary indexed condition, and to 1 intervention - of which Drotrecogin alfa (activated) is the first listed.
NCT00386425 names 20 study sites across 16 states, led by California, Arizona, Other.
Frequently Asked Questions
What is clinical trial NCT00386425 about?
NCT00386425 is a clinical study titled "Evaluate Protein C Levels in Severe Sepsis Patients on Drotrecogin Alfa (Activated)". 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 ...
What is the current status of trial NCT00386425?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 486 participants. The study started on 2006-11. Estimated completion is 2009-08.
What conditions does trial NCT00386425 study?
This clinical trial studies the following conditions: Severe Sepsis.
What interventions are being tested in trial NCT00386425?
The interventions under investigation include: Drotrecogin alfa (activated) (DRUG).
Who is sponsoring clinical trial NCT00386425?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00386425 being conducted?
This trial has 20 study locations across Arizona, California, District of Columbia, Florida, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00386425's enrollment target sits among peer trials
486 4th of 9 higher than 6 of 9 other Severe Sepsis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Severe Sepsis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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