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

July 19, 2007 updated by: Avant Immunotherapeutics
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94115
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
    • Florida
      • Gainesville, Florida, United States, 32610
      • Orlando, Florida, United States, 32803
      • Sarasota, Florida, United States, 34239
    • Georgia
      • Atlanta, Georgia, United States, 30342
    • Illinois
      • Chicago, Illinois, United States, 60612
    • Maryland
      • Towson, Maryland, United States, 21204
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
      • Springfield, Massachusetts, United States, 01199
    • Michigan
      • Detroit, Michigan, United States, 48202
      • Lansing, Michigan, United States, 48910
    • Ohio
      • Cincinnati, Ohio, United States, 45219
    • Tennessee
      • Memphis, Tennessee, United States, 38120
    • Texas
      • Houston, Texas, United States, 77030
    • Virginia
      • Danville, Virginia, United States, 24541
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
      • Milwaukee, Wisconsin, United States, 53215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Reduction in death & myocardial infarction (MI)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Avant Immunotherapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Study Completion

December 1, 2005

Study Registration Dates

First Submitted

April 29, 2004

First Submitted That Met QC Criteria

May 3, 2004

First Posted (Estimate)

May 4, 2004

Study Record Updates

Last Update Posted (Estimate)

July 20, 2007

Last Update Submitted That Met QC Criteria

July 19, 2007

Last Verified

July 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TP10-ACS-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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