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

Myocardial Ischemia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00082121
• Other study ID #: TP10-ACS-002
• Status: Completed
• Phase: Phase 2
• First received: April 29, 2004
• Last updated: July 19, 2007
• Start date: April 2004
• Est. completion date: December 2005

Study information

• Verified date: July 2007
• Source: Avant Immunotherapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

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

Intervention

Drug:
• TP10

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Avant Immunotherapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in death & myocardial infarction (MI)