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

Phase 2

Completed

• Conditions: Myocardial Ischemia; Coronary Arteriosclerosis; Aortic Valve Insufficiency; Mitral Valve Insufficiency

• Registration Number: NCT00082121
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2004-04-29
• Study First Submitted QC: 2004-05-03
• Study First Posted: 2004-05-04
• Study Completion: 2005-12
• Status Verified: 2007-07
• Last Update Submitted: 2007-07-19
• Last Update Posted: 2007-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Reduction in death & myocardial infarction (MI)