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pexelizumab in conjunction with CABG

Phase 3

Coronary Artery Disease | Monoclonal antibody | Cardiovascular |AstraZeneca PLC|Trials Updated: Feb 22, 2018

pexelizumab in conjunction with CABG development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Jul 2004

pexelizumab in conjunction with CABG 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 Enrollment4,000

FDA Designations

No designations recorded

pexelizumab in conjunction with CABG clinical trials

pexelizumab in conjunction with CABG · 1 trial · 1 indication

Phase 3 1
NCT00088179Pexelizumab in Patients Undergoing Coronary Artery Bypass Grafting With Cardiopulmonary Bypass (PRIMO-CABG II)Coronary Artery Disease
COMPLETED4,000 Analytics
PHASE3COMPLETED
Pexelizumab in Patients Undergoing Coronary Artery Bypass Grafting With Cardiopulmonary Bypass (PRIMO-CABG II)
Coronary Artery DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Reduction in mortality.
Reduction in MI incidence.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
pexelizumab in conjunction with CABGDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites188

Inclusion Criteria: * be at least 18 years of age; * have 2 or more of the following risk factors: • diabetes mellitus; • repeat CABG; • the need for urgent intervention, defined according to the ACC/AHA guidelines as being patients who are required to stay in the hospital due to medical factors...

Countries:United StatesFranceGermanyNetherlands
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Frequently asked questions about pexelizumab in conjunction with CABG

What is pexelizumab used for in coronary artery disease?

Pexelizumab was studied as an add-on treatment for patients with coronary artery disease undergoing coronary artery bypass grafting (CABG) with cardiopulmonary bypass. It was given in conjunction with CABG to reduce complications associated with the procedure. It is an investigational monoclonal antibody and is not an approved therapy.

What does pexelizumab target?

Pexelizumab targets complement protein C5. It is a monoclonal antibody that inhibits C5, aiming to block the complement-mediated inflammatory response that can occur during cardiac surgery with cardiopulmonary bypass. By binding C5, it is designed to limit downstream inflammatory injury in patients undergoing CABG.

Who is developing pexelizumab?

Pexelizumab was developed by AstraZeneca PLC, which trades under the ticker AZN. The company sponsored the Phase 3 PRIMO-CABG II trial evaluating pexelizumab in patients undergoing coronary artery bypass grafting with cardiopulmonary bypass.

What phase is pexelizumab in?

Pexelizumab was in Phase 3 clinical development for coronary artery disease in patients undergoing CABG. The Phase 3 PRIMO-CABG II trial has been completed. Pexelizumab is an investigational agent and is not approved for use.

What clinical trials is pexelizumab in?

Pexelizumab was evaluated in the Phase 3 PRIMO-CABG II trial, NCT00088179, titled Pexelizumab in Patients Undergoing Coronary Artery Bypass Grafting With Cardiopulmonary Bypass. The trial enrolled 4,000 participants across the United States, France, Germany, and the Netherlands and has been completed.