Safety and Efficacy of TP10, a Complement Inhibitor, in Adult Women Undergoing Cardiopulmonary Bypass Surgery
1 other identifier
interventional
300
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2004
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2004
CompletedFirst Submitted
Initial submission to the registry
April 29, 2004
CompletedFirst Posted
Study publicly available on registry
May 4, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedJuly 20, 2007
July 1, 2007
April 29, 2004
July 19, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction in death & myocardial infarction (MI)
Interventions
Eligibility Criteria
You may qualify if:
- Female
- To undergo high-risk cardiac surgery with cardiopulmonary bypass pump (CPB)
- CABG alone or with valve surgery
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Unknown Facility
San Francisco, California, 94115, United States
Unknown Facility
Washington D.C., District of Columbia, 20010, United States
Unknown Facility
Gainesville, Florida, 32610, United States
Unknown Facility
Orlando, Florida, 32803, United States
Unknown Facility
Sarasota, Florida, 34239, United States
Unknown Facility
Atlanta, Georgia, 30342, United States
Unknown Facility
Chicago, Illinois, 60612, United States
Unknown Facility
Towson, Maryland, 21204, United States
Unknown Facility
Boston, Massachusetts, 02118, United States
Unknown Facility
Springfield, Massachusetts, 01199, United States
Unknown Facility
Detroit, Michigan, 48202, United States
Unknown Facility
Lansing, Michigan, 48910, United States
Unknown Facility
Cincinnati, Ohio, 45219, United States
Unknown Facility
Memphis, Tennessee, 38120, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
Danville, Virginia, 24541, United States
Unknown Facility
Madison, Wisconsin, 53792, United States
Unknown Facility
Milwaukee, Wisconsin, 53215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 29, 2004
First Posted
May 4, 2004
Study Start
April 1, 2004
Study Completion
December 1, 2005
Last Updated
July 20, 2007
Record last verified: 2007-07