Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00386425
Status:
COMPLETED
Last Update Posted:
2010-12-16
First Post:
2006-10-06
Brief Title:
Evaluate Protein C Levels in Severe Sepsis Patients on Drotrecogin Alfa Activated
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
Official Title:
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
Status Verified Date:
2010-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 microgramkilogramhour mcgkghour 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 andor longer administration time
Note The protocol was amended to remove the option of shorter infusion durations
Note The protocol was amended to remove the option of shorter infusion durations
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| F1K-MC-EVDK | OTHER | Eli Lilly and Company | None |