Study of Alirocumab (REGN727/SAR236553) in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) Undergoing Low-density Lipoprotein (LDL) Apheresis Therapy

Completed · Phase 3 · Has a placebo group

Conditions studied: Heterozygous Familial Hypercholesterolemia

In brief

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.

Key facts

Study ID

NCT02326220

Run by

Regeneron Pharmaceuticals

People needed

62

Starts

2015-03-31

Expected to finish

2016-04-30

Last updated by the study team

2020-05-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women ≥18 years of age at the time of the screening visit
• Diagnosis of HeFH (Heterozygous familial hypercholesterolemia)
• Currently undergoing LDL (low-density lipoprotein) apheresis therapy QW (weekly) or Q2W (every 2 weeks) or at least 8 weeks prior to the screening visit

You may not qualify if…

• Homozygous FH (familial hypercholesterolemia)
• Background medical LMT (lipid-modifying therapy) (if applicable) that has not been stable for at least 8 weeks prior to the screening visit
• LDL apheresis schedule/ apheresis settings that have not been stable for at least 8 weeks prior to the screening visit
• An LDL apheresis schedule other than QW to Q2W
• Initiation of a new exercise program or exercise that has not remained stable within 8 weeks prior to the screening visit (week -2)
• Initiation of a new diet or a diet that has not been stable within 8 weeks prior to the screening visit (week -2)
• Use of nutraceuticals or over-the-counter therapies known to affect lipids, at a dose/amount that has not been stable for at least 8 weeks prior to the screening visit (week -2), or between the screening and randomization visit
• Presence of any clinically significant uncontrolled endocrine disease known to influence serum lipids or lipoproteins
• Known history of a positive test for human immunodeficiency virus
• Use of any active investigational drugs within 1 month or 5 half-lives of screening, whichever is longer
• Patients who have been treated with at least 1 dose of alirocumab or any other anti-PCSK9 monoclonal antibody in any other clinical studies
• Pregnant or breastfeeding women

Where it is running

• Study site — Aurora, Colorado, United States
• Study site — Hartford, Connecticut, United States
• Study site — Kansas City, Kansas, United States
• Study site — Scarborough, Maine, United States
• Study site — Rochester, Minnesota, United States
• Study site — Portland, Oregon, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Dresden, Saxony, Germany
• Study site — Berlin, Germany
• Study site — Göttingen, Germany
• Study site — Muenchen (2 Locations), Germany
• Study site — Passau, Germany
• Study site — Rostock, Germany

Full record on ClinicalTrials.gov

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