An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia

• Status: Active, not recruiting
• Trial end date: 2022-07-01

Summary

Primary Objective:

To evaluate the efficacy of alirocumab administered every 2 weeks (Q2W) and every 4 weeks (Q4W) versus placebo after 24 weeks of double-blind (DB) treatment on low-density lipoprotein cholesterol (LDL-C) levels in patients with heterozygous familial hypercholesterolemia (heFH) 8 to 17 years of age on optimal stable daily dose of statin therapy ± other lipid modifying therapies (LMTs) or a stable dose of non-statin LMTs in case of intolerance to statins.

Secondary Objective:

• To evaluate the efficacy of alirocumab versus placebo on low-density lipoprotein cholesterol (LDL-C) levels.

• To evaluate the effects of alirocumab versus placebo on other lipid parameters.

• To evaluate the safety and tolerability of alirocumab in comparison with placebo.

• To evaluate the efficacy, safety, and tolerability of alirocumab after open label treatment.

• To evaluate the development of anti-alirocumab antibodies.

• Phase: Phase 3

Details

• Lead Sponsor: Sanofi
• Collaborator: Regeneron Pharmaceuticals
• Treatments: Antibodies, Monoclonal; Atorvastatin; Atorvastatin Calcium; Cholestyramine Resin; Ezetimibe; Fenofibrate; Fluvastatin; Lovastatin; Niacin; Niacinamide; Nicotinic Acids; Pravastatin; Rosuvastatin Calcium; Simvastatin