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Safety and Efficacy of TP10, a Complement Inhibitor, in Adult Women Undergoing Cardiopulmonary Bypass Surgery
This study is currently recruiting patients.
| Sponsored by: | Avant Immunotherapeutics |
|---|---|
| Information provided by: | Avant Immunotherapeutics |
Purpose
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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Myocardial Ischemia Coronary Arteriosclerosis Aortic Valve Insufficiency Mitral Valve Insufficiency |
Drug: TP10 |
Phase II |
MedlinePlus related topics: Circulatory Disorders; Coronary Disease; Heart Diseases; Heart Diseases--Prevention; Heart Valve Diseases
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Expected Total Enrollment: 300
Study start: April 2004
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Female
Criteria
Inclusion Criteria:
Exclusion Criteria:
Location
and Contact
Information
More Information
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