Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00045760
Status:
COMPLETED
Last Update Posted:
2006-07-20
First Post:
2002-09-09
Brief Title:
The Study of Drotrecogin Alfa Activated in a Subpopulation of Adult Patients With Severe Sepsis
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2006-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Severe sepsis is defined as a systemic inflammatory response syndrome that results from infection and is associated with acute organ dysfunction It usually results from bacterial infections but it may occur in response to other pathogens such as fungi viruses and parasites
Detailed Description:
Drotrecogin alfa activated a recombinant form of human activated protein C is the first therapeutic intervention shown to reduce all-cause mortality in severe sepsis In the Phase 3 study F1K-MC-EVAD PROWESS 1690 patients were randomly assigned to receive a 96-hour intravenous infusion of drotrecogin alfa activated 24 microgramskgh or placebo 850 patients and 840 patients respectively Overall administration of drotrecogin alfa activated yielded a clinically significant reduction in 28-day all-cause mortality 247 of drotrecogin alfa activated patients died versus 308 of placebo patients 194 relative risk reduction p0005 Bernard et al 2001 The only safety concern noted in the Phase 3 trial was an increased risk of serious bleeding among drotrecogin alfa activated patients 35 versus 20 of placebo patients The difference between the two treatment groups in the number of patients who experienced a serious bleeding event was due to the greater number of drotrecogin alfa activated patients who experienced a serious bleeding event that was related to a procedure for example bleeding that resulted from the placement of a catheter or nephrostomy tube The number of patients who experienced spontaneous serious bleeding events was similar between the two treatment groups
The Regulatory authorities have approved the use of drotrecogin alfa activated in severe sepsis patients with a high level of disease severity and risk of death Thus the regulatory authorities have requested a study evaluating drotrecogin alfa activated in a specific subpopulation of patients with severe sepsis and at lower risk of death
The Regulatory authorities have approved the use of drotrecogin alfa activated in severe sepsis patients with a high level of disease severity and risk of death Thus the regulatory authorities have requested a study evaluating drotrecogin alfa activated in a specific subpopulation of patients with severe sepsis and at lower risk of death
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-EVCM | None | None | None |
| F1K-MC-EVCL | None | None | None |