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

Avant Immunotherapeutics

Status and phase: Completed; Phase 2

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

Treatments: Drug: TP10

Study type: Interventional

Funder types: Industry

Identifiers

NCT00082121

TP10-ACS-002

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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