Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00088179
Status:
COMPLETED
Last Update Posted:
2018-02-22
First Post:
2004-07-21
Brief Title:
Pexelizumab in Patients Undergoing Coronary Artery Bypass Grafting With Cardiopulmonary Bypass PRIMO-CABG II
Sponsor:
Alexion Pharmaceuticals Inc
Organization:
Alexion Pharmaceuticals Inc
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Parallel-group Placebo-Controlled Study of Pexelizumab in Patients Undergoing Coronary Artery Bypass Grafting With Cardiopulmonary Bypass PRIMO-CABG II
Status:
COMPLETED
Status Verified Date:
2018-02
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:
During a heart bypass procedure a substance called complement is activated by the body This complement activation causes an inflammatory response that can lead to side affects such as chest pain heart attacks stroke heart failure or death The purpose of this study is to find out if the study drug pexelizumab that blocks complement activation can reduce such side effects and be given safely to patients requiring the bypass procedure with the use of the heart-lung machine
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