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pexelizumab

Phase 3

Cardio-pulmonary Bypass | Monoclonal antibody | Cardiovascular |AstraZeneca PLC|Trials Updated: Feb 23, 2017

pexelizumab development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Oct 2002

pexelizumab target and mechanism

Molecular targetC5
Target classInhibitor
ModalityMonoclonal antibody

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment3,000

FDA Designations

No designations recorded

pexelizumab clinical trials

pexelizumab · 1 trial · 2 indications

Phase 3 1
NCT00048308Effect of Pexelizumab on All-Cause Mortality and Myocardial Infarction in Patients Undergoing Coronary Artery Bypass Graft Surgery With Cardio-Pulmonary BypassCardio-pulmonary Bypass
COMPLETED3,000 Analytics
PHASE3COMPLETED
Effect of Pexelizumab on All-Cause Mortality and Myocardial Infarction in Patients Undergoing Coronary Artery Bypass Graft Surgery With Cardio-Pulmonary Bypass
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Interventions

NameTypeDescription
pexelizumabDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites186

INCLUSION CRITERIA: The study population will be drawn from patients undergoing CABG or CABG plus valve surgery using a bypass pump. In addition, they must meet all of the following criteria: * be at least 18 years of age; * have one or more of the following risk factors: * diabetes mellitus; * pr...

Countries:United StatesCanada
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Frequently asked questions about pexelizumab

What is pexelizumab?

Pexelizumab is an investigational monoclonal antibody developed by AstraZeneca PLC. It was studied in patients undergoing coronary artery bypass graft surgery with cardio-pulmonary bypass, a cardiovascular procedure. It is a Phase 3 candidate and is not described as approved.

What is pexelizumab used for?

Pexelizumab was studied for use in patients undergoing coronary artery bypass graft surgery with cardio-pulmonary bypass. Its Phase 3 trial evaluated its effect on all-cause mortality and myocardial infarction in that surgical setting. It is an investigational agent, not a marketed therapy.

What does pexelizumab target?

Pexelizumab targets C5, a complement protein, and acts as an inhibitor of that target. By binding C5, the monoclonal antibody is designed to block complement-mediated activity associated with cardio-pulmonary bypass. This mechanism was the basis for its study in cardiac surgery.

Who makes pexelizumab?

Pexelizumab is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca sponsored the Phase 3 program evaluating the antibody in coronary artery bypass graft surgery with cardio-pulmonary bypass.

What phase is pexelizumab in?

Pexelizumab is in Phase 3 development. Its single Phase 3 trial, NCT00048308, is completed, and no active trials are listed. The drug is investigational and has not been described as FDA approved for any indication.

What clinical trials is pexelizumab in?

Pexelizumab was evaluated in one Phase 3 trial, NCT00048308, titled Effect of Pexelizumab on All-Cause Mortality and Myocardial Infarction in Patients Undergoing Coronary Artery Bypass Graft Surgery With Cardio-Pulmonary Bypass. The completed trial enrolled 3,000 patients across the United States and Canada.