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

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:	Other, 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
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:

Coronary Disease

Arterial Occlusive Diseases

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 September 22, 2008