Completed
Safety and Efficacy of TP10, a Complement Inhibitor, in Adult Women Undergoing Cardiopulmonary Bypass Surgery
What is being tested
Data Collection
Who is being recruted
Aortic Valve Disease+9
+ Aortic Valve Insufficiency
+ Arterial Occlusive Diseases
Over 18 Years
+8 Eligibility Criteria
How is the trial designed
Phase 2
Interventional
Study Start: April 2004
Summary
Principal SponsorAvant Immunotherapeutics
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 2004
Actual date on which the first participant was enrolled.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.
Official TitleSafety and Efficacy of TP10, a Complement Inhibitor, in Adult Women Undergoing Cardiopulmonary Bypass Surgery
Principal SponsorAvant Immunotherapeutics
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
300 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Aortic Valve DiseaseAortic Valve InsufficiencyArterial Occlusive DiseasesArteriosclerosisCardiovascular DiseasesCoronary Artery DiseaseCoronary DiseaseHeart DiseasesHeart Valve DiseasesMitral Valve InsufficiencyVascular DiseasesMyocardial Ischemia
Criteria
3 inclusion criteria required to participate
Female
To undergo high-risk cardiac surgery with cardiopulmonary bypass pump (CPB)
CABG alone or with valve surgery
5 exclusion criteria prevent from participating
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
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has no location dataSave this study to your profile to know when the location data is available.
CompletedNo study centers