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

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Avant Immunotherapeutics
• Treatments: Complement System Proteins

Criteria

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