Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00082121
Status:
COMPLETED
Last Update Posted:
2007-07-20
First Post:
2004-04-29
Brief Title:
Safety and Efficacy of TP10 a Complement Inhibitor in Adult Women Undergoing Cardiopulmonary Bypass Surgery
Sponsor:
Avant Immunotherapeutics
Organization:
Avant Immunotherapeutics
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2007-07
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:
The purpose of this study is to determine if the study drug TP10 which blocks complement release can reduce such side effects of complement inflammation as chest pain or heart attacks and be taken safely in women who undergo cardiopulmonary bypass surgery
Detailed Description:
During cardiac surgery a substance called complement is released by the body This complement causes inflammation which can lead to side effects such as chest pain heart attacks or heart failure The purpose of this study is to determine if the study drug TP10 which blocks complement release can reduce such side events and be taken safely in women
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