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

Tracking Information
First Received Date ^ICMJE	April 29, 2004
Last Updated Date	July 19, 2007
Start Date ^ICMJE	April 2004
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: June 23, 2005)	Reduction in death & myocardial infarction (MI)
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00082121 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy of TP10, a Complement Inhibitor, in Adult Women Undergoing Cardiopulmonary Bypass Surgery
Official Title ^ICMJE
Brief Summary	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	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 Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Other, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Myocardial Ischemia Coronary Arteriosclerosis Aortic Valve Insufficiency Mitral Valve Insufficiency
Intervention ^ICMJE	Drug: TP10
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	300
Completion Date	December 2005
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00082121
Responsible Party
Study ID Numbers ^ICMJE	TP10-ACS-002
Study Sponsor ^ICMJE	Avant Immunotherapeutics
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Avant Immunotherapeutics
Verification Date	July 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP