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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Masking: Double

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.

Interventions

  • Drug: TP10

Clinical Trial Outcome Measures

Primary Measures

  • Reduction in death & myocardial infarction (MI)

Participating in This Clinical Trial

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 Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Avant Immunotherapeutics

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