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

Avant Immunotherapeutics300 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

300

Conditions

Myocardial Ischemia Coronary Arteriosclerosis Aortic Valve Insufficiency Mitral Valve Insufficiency

Interventions

TP10DRUG

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (18)

Unnamed facility

San Francisco, California, United States

Unnamed facility

Washington D.C., District of Columbia, United States

Unnamed facility

Gainesville, Florida, United States

Outcomes

Primary Outcomes

Reduction in death & myocardial infarction (MI)

Data from ClinicalTrials.gov

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