Study Of Alirocumab (REGN727/SAR236553) In Patients With Heterozygous Familial Hypercholesterolemia (HeFH) Undergoing Low-density Lipoprotein (LDL) Apheresis Therapy
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 14-010105
NCT ID: NCT02326220
Sponsor Protocol Number: R727-CL-1216
About this study
This is a randomized, double-blind, placebo-controlled, parallel-group study to evaluate the effect of alirocumab in comparison with placebo on the frequency of LDL apheresis treatments in patients with HeFH undergoing LDL apheresis therapy.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
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To evaluate the effect of alirocumab on frequency of standard apheresis treatments [weekly or every 2 weeks (Q2W)] in heterozygous familial hypercholesterolaemia (HeFH).
Read More on PubMed