Last updated on December 2018

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

Brief description of study

Primary Objective:

To evaluate the efficacy of alirocumab administered every 2 weeks (Q2W), on low-density lipoprotein cholesterol (LDL-C) levels of treatment in children with homozygous familial hypercholesterolemia (hoFH) 8 to 17 years of age on top of background treatments.

Secondary Objectives:

  • To evaluate the efficacy of alirocumab after treatment on LDL-C levels.
  • To evaluate the effects of alirocumab on other lipid parameters.
  • To evaluate the safety and tolerability of alirocumab.

Detailed Study Description

The study duration is up to 62 weeks, which includes (if needed) a run-in period of up to 4 weeks, a screening period of up to 2 weeks, a treatment period of up to 48 weeks, and a follow-up of 8 weeks.

Clinical Study Identifier: NCT03510715

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Investigational Site Number 4840006
Oaxaca, Mexico
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Recruitment Status: Open

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