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Safety and Efficacy of TP10, a Complement Inhibitor, in Adult Women Undergoing Cardiopulmonary Bypass Surgery Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Safety and Efficacy of TP10, a Complement Inhibitor, in Adult Women Undergoing Cardiopulmonary Bypass Surgery conditions. Clinical Trials Search.org is a site committed 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 health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts 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 permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Safety and Efficacy of TP10, a Complement Inhibitor, in Adult Women Undergoing Cardiopulmonary Bypass Surgery clinical trial. Participants oftentimes recieve the most expert healthcare available for their Safety and Efficacy of TP10, a Complement Inhibitor, in Adult Women Undergoing Cardiopulmonary Bypass Surgery condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.

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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

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