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

NCT ID: NCT00082121

Last Updated: 2007-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2005-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Myocardial Ischemia Coronary Arteriosclerosis Aortic Valve Insufficiency Mitral Valve Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Interventions

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TP10

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Avant Immunotherapeutics

INDUSTRY

Sponsor Role lead

Locations

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San Francisco, California, United States

Site Status

Washington D.C., District of Columbia, United States

Site Status

Gainesville, Florida, United States

Site Status

Orlando, Florida, United States

Site Status

Sarasota, Florida, United States

Site Status

Atlanta, Georgia, United States

Site Status

Chicago, Illinois, United States

Site Status

Towson, Maryland, United States

Site Status

Boston, Massachusetts, United States

Site Status

Springfield, Massachusetts, United States

Site Status

Detroit, Michigan, United States

Site Status

Lansing, Michigan, United States

Site Status

Cincinnati, Ohio, United States

Site Status

Memphis, Tennessee, United States

Site Status

Houston, Texas, United States

Site Status

Danville, Virginia, United States

Site Status

Madison, Wisconsin, United States

Site Status

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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TP10-ACS-002

Identifier Type: -

Identifier Source: org_study_id