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Safety and Efficacy of TP10, a Complement Inhibitor, in Adult Women Undergoing Cardiopulmonary Bypass Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00082121
Recruitment Status : Completed
First Posted : May 4, 2004
Last Update Posted : July 20, 2007
Information provided by:
Avant Immunotherapeutics

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.

Condition or disease Intervention/treatment Phase
Myocardial Ischemia Coronary Arteriosclerosis Aortic Valve Insufficiency Mitral Valve Insufficiency Drug: TP10 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Study Start Date : April 2004
Study Completion Date : December 2005

Primary Outcome Measures :
  1. Reduction in death & myocardial infarction (MI)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Female
  • To undergo high-risk cardiac surgery with cardiopulmonary bypass pump (CPB)
  • CABG alone or with valve surgery

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00082121

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United States, California
San Francisco, California, United States, 94115
United States, District of Columbia
Washington, District of Columbia, United States, 20010
United States, Florida
Gainesville, Florida, United States, 32610
Orlando, Florida, United States, 32803
Sarasota, Florida, United States, 34239
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
Detroit, Michigan, United States, 48202
Lansing, Michigan, United States, 48910
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
Sponsors and Collaborators
Avant Immunotherapeutics
Layout table for additonal information Identifier: NCT00082121    
Other Study ID Numbers: TP10-ACS-002
First Posted: May 4, 2004    Key Record Dates
Last Update Posted: July 20, 2007
Last Verified: July 2007
Keywords provided by Avant Immunotherapeutics:
cardiac bypass
complement activation
Additional relevant MeSH terms:
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Myocardial Ischemia
Coronary Artery Disease
Mitral Valve Insufficiency
Aortic Valve Insufficiency
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arterial Occlusive Diseases
Heart Valve Diseases