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Sponsored by: |
Avant Immunotherapeutics |
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Information provided by: | Avant Immunotherapeutics |
ClinicalTrials.gov Identifier: | NCT00082121 |
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.
Condition | Intervention | Phase |
---|---|---|
Myocardial Ischemia Coronary Arteriosclerosis Aortic Valve Insufficiency Mitral Valve Insufficiency |
Drug: TP10 |
Phase II |
Study Type: | Interventional |
Study Design: | Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 300 |
Study Start Date: | April 2004 |
Estimated Study Completion Date: | December 2005 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
San Francisco, California, United States, 94115 | |
United States, District of Columbia | |
Washington, District of Columbia, United States, 20010 | |
United States, Florida | |
Sarasota, Florida, United States, 34239 | |
Orlando, Florida, United States, 32803 | |
Gainesville, Florida, United States, 32610 | |
United States, Georgia | |
Atlanta, Georgia, United States, 30342 | |
United States, Illinois | |
Chicago, Illinois, United States, 60612 | |
United States, Maryland | |
Towson, Maryland, United States, 21204 | |
United States, Massachusetts | |
Boston, Massachusetts, United States, 02118 | |
Springfield, Massachusetts, United States, 01199 | |
United States, Michigan | |
Lansing, Michigan, United States, 48910 | |
Detroit, Michigan, United States, 48202 | |
United States, Ohio | |
Cincinnati, Ohio, United States, 45219 | |
United States, Tennessee | |
Memphis, Tennessee, United States, 38120 | |
United States, Texas | |
Houston, Texas, United States, 77030 | |
United States, Virginia | |
Danville, Virginia, United States, 24541 | |
United States, Wisconsin | |
Madison, Wisconsin, United States, 53792 | |
Milwaukee, Wisconsin, United States, 53215 |
Study ID Numbers: | TP10-ACS-002 |
Study First Received: | April 29, 2004 |
Last Updated: | July 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00082121 History of Changes |
Health Authority: | United States: Food and Drug Administration |
cardiac bypass CABG complement activation |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Aortic Valve Insufficiency Myocardial Ischemia Vascular Diseases |
Ischemia Arteriosclerosis Coronary Artery Disease Heart Valve Diseases Mitral Valve Insufficiency |
Arterial Occlusive Diseases Aortic Valve Insufficiency Heart Diseases Myocardial Ischemia Vascular Diseases Arteriosclerosis Ischemia |
Heart Valve Diseases Coronary Disease Pathologic Processes Cardiovascular Diseases Coronary Artery Disease Mitral Valve Insufficiency |