Completed

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

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What is being tested

Data Collection

Who is being recruted

Aortic Valve Disease
+9

+ Aortic Valve Insufficiency
+ Arterial Occlusive Diseases
Over 18 Years
See all eligibility criteria
How is the trial designed

Phase 2
Interventional
Study Start: April 2004
See protocol details

Summary

Principal SponsorAvant Immunotherapeutics
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 2004Actual 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 
NCT00082121
Principal SponsorAvant Immunotherapeutics
Last updated: January 13, 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 enrolledTotal number of participants that the clinical trial aims to recruit.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
FemaleBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Aortic Valve Disease
Aortic Valve Insufficiency
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Coronary Artery Disease
Coronary Disease
Heart Diseases
Heart Valve Diseases
Mitral Valve Insufficiency
Vascular Diseases
Myocardial Ischemia
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

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