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

Sponsor

Avant Immunotherapeutics (Industry)

Overall Status

Completed

CT.gov ID

NCT00082121

Collaborator

(none)

300

Enrollment

Locations

Duration (Months)

16.7

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Ischemia Coronary Arteriosclerosis Aortic Valve Insufficiency Mitral Valve Insufficiency	Drug: TP10	Phase 2

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 Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Study Start Date :

Apr 1, 2004

Study Completion Date :

Dec 1, 2005

Outcome Measures

Primary Outcome Measures

Reduction in death & myocardial infarction (MI) []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	City	State	Country	Postal Code
1	San Francisco	California	United States	94115
2	Washington	District of Columbia	United States	20010
3	Gainesville	Florida	United States	32610
4	Orlando	Florida	United States	32803
5	Sarasota	Florida	United States	34239
6	Atlanta	Georgia	United States	30342
7	Chicago	Illinois	United States	60612
8	Towson	Maryland	United States	21204
9	Boston	Massachusetts	United States	02118
10	Springfield	Massachusetts	United States	01199
11	Detroit	Michigan	United States	48202
12	Lansing	Michigan	United States	48910
13	Cincinnati	Ohio	United States	45219
14	Memphis	Tennessee	United States	38120
15	Houston	Texas	United States	77030
16	Danville	Virginia	United States	24541
17	Madison	Wisconsin	United States	53792
18	Milwaukee	Wisconsin	United States	53215