NCT00082121

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (planned)
• Sponsor: Avant Immunotherapeutics · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myocardial Ischemia
• Coronary Arteriosclerosis
• Aortic Valve Insufficiency
• Mitral Valve Insufficiency

Interventions

Type	Name	Description
DRUG	TP10

Timeline

• Start date: 2004-04-01
• Completion: 2005-12-01
• First posted: 2004-05-04
• Last updated: 2007-07-20

Locations

18 sites across 1 country: United States