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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT02326220
Phase
PHASE3
Status
Completed

Conditions

  • Heterozygous Familial Hypercholesterolemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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 Dates

Start date
Mar 31, 2015
Status verified
Apr 2020
Primary completion
Jan 31, 2016
Completion
Apr 30, 2016

Study Design

Enrollment
62 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Placebo Q2W (Double Blind Period)
    Placebo (for alirocumab) subcutaneous (SC) injection Q2W up to Week 16.
  • Experimental: Alirocumab 150 mg Q2W (Double Blind Period)
    Alirocumab 150 mg SC injection Q2W up to Week 16.
  • Experimental: Alirocumab 150 Q2W (Open Label Treatment Period)
    Alirocumab 150 mg SC injection Q2W starting from Week 18 up to Week 76.

Primary Outcome Measure

Change in Standardized Rate of Apheresis Treatments From Week 7 to Week 18 [ Time Frame: Week 7 to Week 18 (before start of open-label treatment) ]

Locations (7)

FacilityCityStateZIPSite coordinators
-AuroraColorado--
-HartfordConnecticut--
-Kansas CityKansas--
-ScarboroughMaine--
-RochesterMinnesota--
-PortlandOregon--
-PhiladelphiaPennsylvania--

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