Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00037687
Status:
TERMINATED
Last Update Posted:
2005-06-24
First Post:
2002-05-20
Brief Title:
Safety and Efficacy of Recombinant Human Platelet-Activating Factor Acetylhydrolase for the Treatment of Severe Sepsis
Sponsor:
ICOS Corporation
Organization:
ICOS Corporation
Study Overview
Official Title:
A Phase 3 Study to Demonstrate the Safety and Efficacy of Recombinant Platelet-Activating Factor Acetylhydrolase rPAF-AH Pafase for Reducing 28 Day All Cause Mortality in Patients With Severe Sepsis
Status:
TERMINATED
Status Verified Date:
2003-01
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:
The objective of this study is to demonstrate that rPAF-AH is safe and reduces 28 day all cause mortality in patients with severe sepsis
Detailed Description:
This study is a randomized double-blind placebo-controlled multicenter study of rPAF-AH compared to placebo in patients with severe sepsis Eligible patients from investigative sites located throughout the United States and other countries will be randomized to receive either rPAF-AH or placebo administered daily for five consecutive days by intravenous IV infusion All patients will be evaluated for safety and efficacy endpoints over 28 days A follow-up evaluation will occur approximately 6 months after Day 28 to assess functional status and quality of life
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 |
|---|---|---|---|
| BB-IND 9538 | None | None | None |