Trial | NCT00082121  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    tp10 ...

  • Study Participants

    300
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.
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 Started
Apr 30
2004
Study Completion
Dec 31
2005
Last Update
Jul 20
2007
Estimate

Drug TP10

Criteria 

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
No Results Posted