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

Completed · Phase 2

Conditions studied: Myocardial Ischemia, Coronary Arteriosclerosis, Aortic Valve Insufficiency, Mitral Valve Insufficiency

In brief

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.

Key facts

Study ID

NCT00082121

Run by

Avant Immunotherapeutics

People needed

300

Starts

2004-04-01

Expected to finish

2005-12-01

Last updated by the study team

2007-07-20

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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

Where it is running

• Study site — San Francisco, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Gainesville, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Sarasota, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Towson, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Springfield, Massachusetts, United States
• Study site — Detroit, Michigan, United States
• Study site — Lansing, Michigan, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Memphis, Tennessee, United States
• Study site — Houston, Texas, United States
• Study site — Danville, Virginia, United States
• Study site — Madison, Wisconsin, United States
• Study site — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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