Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00046072
Status:
COMPLETED
Last Update Posted:
2005-12-12
First Post:
2002-09-19
Brief Title:
A Safety and Efficacy Study of Intravenous E5564 in Patients With Severe Sepsis
Sponsor:
Eisai Inc
Organization:
Eisai Inc
Study Overview
Official Title:
A Double-Blind Placebo-Controlled Study of E5564 A Lipid A Antagonist Administered by Twice Daily Infusions in Patients With Severe Sepsis
Status:
COMPLETED
Status Verified Date:
2005-12
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:
Sepsis is a serious condition where there is inflammation and damage to body tissue usually caused by an infection This infection can lead to decreased function of vital body organs and in some cases may lead to permanent health problems or death
Much of the injury is due to endotoxin a harmful substance produced by certain types of bacteria An endotoxin antagonist is designed to block the effects of endotoxin
This study is designed to study the safety and efficacy when treating patients with severe sepsis
Much of the injury is due to endotoxin a harmful substance produced by certain types of bacteria An endotoxin antagonist is designed to block the effects of endotoxin
This study is designed to study the safety and efficacy when treating patients with severe sepsis
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