This is an open-label study designed to evaluate the long-term safety and efficacy of evinacumab, a fully human ANGPTL3 antibody, in patients with homozygous familial hypercholesterolemia (HoFH), in a real-life setting in Canada. Eligible patients for this study are male and female adult patients with HoFH. Evinacumab will be added on top of the patient's background lipid-modifying therapy (LMT), including statins, ezetimibe, PCSK9 inhibitors, lomitapide or other lipid lowering therapies. This study will be conducted using an hybrid (on-site, foldable sites) approach. Patients will enter the current study, in an open-label treatment period, following their screening. This study will continue until reimbursement of evinacumab in Canada or for a maximum of 24 months. The end of study (EoS) visit will be scheduled 4 weeks after the last dose has been injected and will be followed by a 52-week follow-up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Evinacumab 15 mg/kg administered intravenously every 4 weeks
Ecogene-21
Saguenay, Quebec, Canada
Change in lipid profile
Change in total cholesterol, LDL-Cholesterol, HDL-Cholesterol, triglyceride, non-HDL-Cholesterol and apolipoprotein B plasma concentration
Time frame: Every 4 weeks up to 2 years
Change in aspartate transaminase (AST) plasma concentration
Time frame: Every 4 weeks up to 2 years
change in alanine aminotransferase (ALT) plasma concentration
Time frame: Every 4 weeks up to 2 years
Lipoprotein (a)
Time frame: Yearly up to 2 years
Complete blood count
Time frame: Every 12 weeks up to 2 years
Total bilirubin
Time frame: Every 12 weeks up to 2 years
Creatine phosphokinase
Time frame: Every 12 weeks up to 2 years
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