Hypercholesterolaemia Clinical Trial
Official title:
An 8-Week Open-Label, Sequential, Repeated Dose-Finding Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia Followed by an Extension Phase
Primary Objective:
To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels
after 8 weeks of treatment in heterozygous familial hypercholesterolemia (heFH) participants
aged of 8 to 17 years, with LDL-C >=130 milligrams per deciliter (mg/dL) (3.37 millimoles per
litre [mmol/L]) 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 for at
least 4 weeks prior to the screening period.
Secondary Objective:
- To evaluate the safety and tolerability of alirocumab.
- To evaluate the pharmacokinetics profile of alirocumab.
- To evaluate the effects of alirocumab on other lipid parameters.
For Cohorts 1 to 3, a study duration of approximately 16-23 weeks (screening period: up to 6
(+1) weeks, open-label dose finding treatment period: 8 weeks, follow up period: 6-8 weeks).
For Cohort 4, a study duration of approximately 14-19 weeks (screening period up to 6 [+1]
weeks, open-label dose finding treatment period: 12 weeks).
Optional extension period: up to a maximum of 2 years for the first participants enrolled in
Cohorts 1 to 3, but a maximum of approximately 5 months for the first participants enrolled
in Cohort 4.
For all participants who declined participation in the phase 3 study, their last alirocumab
injection was on December 2018.
;
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