Cup 14366

Cup 14366

Primary Investigator: Kereiakes

Drug/Device Information
To provide access to alirocumab prior to its commercial availability in patients with severe hypercholesterolemia not controlled with maximal tolerated dose of lipid-lowering therapy
Alirocumab is a fully human monoclonal antibody (mAb) that binds with high affinity to PCSK9. After secretion, PCSK9 binds to the extracellular domain of the LDLR
Open-label expanded access program
Sanofi Aventis
Major Inclusion and Exclusion
LDL levels ≥ 160 mg/dL despite maximal tolerated dose of lipid-lowering therapy
Must have heterozygous familial hypercholesterolemia (HeFH) or coronary heart disease (CHD) documented
No LDL C <160 mg/dL
No use of fibrates other than fenofibrate within 12 weeks
No recent (within 3 months) MI, unstable angina leading to hospitalization, uncontrolled cardiac arrhythmia, CABG, PCI, carotid surgery or stenting, cerebrovascular accident, transient vascular diseas