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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00386425
The ClinicalTrials.gov registry entry for NCT00386425 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 486 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 6,157-participant average among 9 other Severe Sepsis trials with a reported enrollment target (92% lower). The listed sponsor is Eli Lilly and Company, which has 1,341 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 16 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.