Conditions: Heterozygous Familial Hypercholesterolemia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 62
Healthy volunteers: no

Brief summary:
The primary objective of the study is to evaluate the effect of alirocumab 150 mg every 2 weeks (Q2W) in comparison with placebo on the frequency of low-density lipoprotein (LDL) apheresis treatments in participants with heterozygous familial hypercholesterolemia (HeFH) undergoing weekly or bi-weekly LDL apheresis therapy.

Detailed description:
LDL apheresis removes low-density lipoproteins (LDL) that transport cholesterol in the plasma portion of the blood. This treatment is mainly used for familial hypercholesterolemia, but can be used in other rare diseases. Familial hypercholesterolemia (HeFH) is an inherited genetic condition that causes accumulation of cholesterol in the blood, which can lead to atherosclerosis and heart disease. This treatment is recommended for patients who do not respond to dietary and/or medication control of LDL cholesterol.

Arms:
arm 1: Placebo (for alirocumab) subcutaneous (SC) injection Q2W up to Week 16. arm 2: Alirocumab 150 mg SC injection Q2W up to Week 16. arm 3: Alirocumab 150 mg SC injection Q2W starting from Week 18 up to Week 76.

Interventions: intervention 1: Placebo intervention 2: Alirocumab
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: