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

This study has been completed.
Sponsor:
Information provided by:
Avant Immunotherapeutics
ClinicalTrials.gov Identifier:
NCT00082121
First received: April 29, 2004
Last updated: July 19, 2007
Last verified: July 2007
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Gainesville, Florida, United States, 32610
Orlando, Florida, United States, 32803
Sarasota, Florida, United States, 34239
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
Detroit, Michigan, United States, 48202
Lansing, Michigan, United States, 48910
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

No publications provided

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

Keywords provided by Avant Immunotherapeutics:
cardiac bypass
CABG
complement activation

Additional relevant MeSH terms:
Aortic Valve Insufficiency
Arteriosclerosis
Coronary Artery Disease
Myocardial Ischemia
Ischemia
Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Coronary Disease
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2014