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OpenTrials
Completed

NCT Number: NCT00082121

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

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.

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Key information

Conditions

Myocardial Ischemia Aortic Valve Disease Aortic Valve Insufficiency Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Arteriosclerosis Coronary Artery Disease Coronary Disease Heart Diseases Heart Valve Diseases Mitral Valve Insufficiency Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

San Francisco, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TP10

Drug

Primary outcomes

  1. Reduction in death & myocardial infarction (MI)

Sponsors and collaborators

Lead sponsor

Avant Immunotherapeutics

Industry

Registry information

Important dates

Study start
2004
Study completion
2005
First posted
May 4, 2004
Registry last updated
Jul 20, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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