Status:
COMPLETED
Safety and Efficacy of TP10, a Complement Inhibitor, in Adult Women Undergoing Cardiopulmonary Bypass Surgery
Lead Sponsor:
Avant Immunotherapeutics
Conditions:
Myocardial Ischemia
Coronary Arteriosclerosis
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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...
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...
Eligibility Criteria
Inclusion
- Female
- To undergo high-risk cardiac surgery with cardiopulmonary bypass pump (CPB)
- CABG alone or with valve surgery
Exclusion
- Acute myocardial infarction (heart attack) within a 3 days of entering the study
- Conditions that may interfere with interpretation of electrocardiogram data
- History of immune deficiency syndrome
- Planned supplemental cardiac surgery or other surgery
- Pregnancy or lactation
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00082121
Start Date
April 1 2004
End Date
December 1 2005
Last Update
July 20 2007
Active Locations (18)
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1
San Francisco, California, United States, 94115
2
Washington D.C., District of Columbia, United States, 20010
3
Gainesville, Florida, United States, 32610
4
Orlando, Florida, United States, 32803