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Safety and Efficacy of TP10, a Complement Inhibitor, in Adult Women Undergoing Cardiopulmonary Bypass Surgery Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Safety and Efficacy of TP10, a Complement Inhibitor, in Adult Women Undergoing Cardiopulmonary Bypass Surgery conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Safety and Efficacy of TP10, a Complement Inhibitor, in Adult Women Undergoing Cardiopulmonary Bypass Surgery Clinical research trials and Safety and Efficacy of TP10, a Complement Inhibitor, in Adult Women Undergoing Cardiopulmonary Bypass Surgery healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Safety and Efficacy of TP10, a Complement Inhibitor, in Adult Women Undergoing Cardiopulmonary Bypass Surgery. Safety and Efficacy of TP10, a Complement Inhibitor, in Adult Women Undergoing Cardiopulmonary Bypass Surgery Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Safety and Efficacy of TP10, a Complement Inhibitor, in Adult Women Undergoing Cardiopulmonary Bypass Surgery clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Safety and Efficacy of TP10, a Complement Inhibitor, in Adult Women Undergoing Cardiopulmonary Bypass Surgery condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Safety and Efficacy of TP10, a Complement Inhibitor, in Adult Women Undergoing Cardiopulmonary Bypass Surgery  Safety and Efficacy of TP10, a Complement Inhibitor, in Adult Women Undergoing Cardiopulmonary Bypass Surgery
Safety and Efficacy of TP10, a Complement Inhibitor, in Adult Women Undergoing Cardiopulmonary Bypass Surgery
For Condition: Coronary Arteriosclerosis,Aortic Valve Insufficiency,Mitral Valve Insufficiency,Myocardial Ischemia,Heart Valve Diseases
Status: Recruiting
Sponsor(s): Avant Immunotherapeutics ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional,Prevention,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Female
Protocol Entry Criteria: Inclusion Criteria: - Female - To undergo high-risk cardiac surgery with cardiopulmonary bypass (CPB) Exclusion Criteria: - Acute myocardial infarction (heart attack) within a week of entering the study - Conditons that may interfere with interpretation of electrocardiogram data - History of immune deficiency syndrome - Planned supplemental cardiac surgery or other surgery - Pregnancy or lactation
Total Enrollment: 300
Location and Contact Information:
Additional Information:
Study ID Numbers: TP10-ACS-002;
Study Start Date: April 2004
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00082121
Other Myocardial Ischemia Studies:
1. Safety and Efficacy of TP10, a Complement Inhibitor, in Adult Women Undergoing Cardiopulmonary Bypass Surgery
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Safety and Efficacy of TP10, a Complement Inhibitor, in Adult Women Undergoing Cardiopulmonary Bypass Surgery
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