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

This study has been completed.

Sponsored by:	Avant Immunotherapeutics
Information provided by:	Avant Immunotherapeutics
ClinicalTrials.gov Identifier:	NCT00082121

Purpose

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.

Condition	Intervention	Phase
Myocardial Ischemia Coronary Arteriosclerosis Aortic Valve Insufficiency Mitral Valve Insufficiency	Drug: TP10	Phase II

MedlinePlus related topics: Heart Attack

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Avant Immunotherapeutics:

Primary Outcome Measures:

Reduction in death & myocardial infarction (MI)

Estimated Enrollment:	300
Study Start Date:	April 2004
Estimated Study Completion Date:	December 2005

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00082121

Locations

United States, California

San Francisco, California, United States, 94115
United States, District of Columbia

Washington, District of Columbia, United States, 20010
United States, Florida

Sarasota, Florida, United States, 34239

Orlando, Florida, United States, 32803

Gainesville, Florida, United States, 32610
United States, Georgia

Atlanta, Georgia, United States, 30342
United States, Illinois

Chicago, Illinois, United States, 60612
United States, Maryland

Towson, Maryland, United States, 21204
United States, Massachusetts

Boston, Massachusetts, United States, 02118

Springfield, Massachusetts, United States, 01199
United States, Michigan

Lansing, Michigan, United States, 48910

Detroit, Michigan, United States, 48202
United States, Ohio

Cincinnati, Ohio, United States, 45219
United States, Tennessee

Memphis, Tennessee, United States, 38120
United States, Texas

Houston, Texas, United States, 77030
United States, Virginia

Danville, Virginia, United States, 24541
United States, Wisconsin

Madison, Wisconsin, United States, 53792

Milwaukee, Wisconsin, United States, 53215

Sponsors and Collaborators

Avant Immunotherapeutics

More Information

Study ID Numbers:	TP10-ACS-002
Study First Received:	April 29, 2004
Last Updated:	July 19, 2007
ClinicalTrials.gov Identifier:	NCT00082121
Health Authority:	United States: Food and Drug Administration

Keywords provided by Avant Immunotherapeutics:

cardiac bypass
CABG
complement activation

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Aortic Valve Insufficiency
Myocardial Ischemia
Vascular Diseases

Ischemia
Arteriosclerosis
Coronary Artery Disease
Heart Valve Diseases
Mitral Valve Insufficiency

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009