Evolocumab Compared to LDL-C Apheresis in Patients Receiving LDL-C Apheresis Prior to Study Enrollment

Part of paid clinical trials in Boca Raton, Florida.

Sponsor
Amgen
Study ID
NCT02585895
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Evolocumab — BIOLOGICAL
    Administered by subcutaneous injection once every 2 weeks
  • Low-density Lipoprotein Cholesterol (LDL-C) Apheresis — PROCEDURE
    Participants received apheresis for LDL-C according the their physician's prescription and local custom.

Study Details

To evaluate the efficacy of subcutaneous (SC) evolocumab, compared to regularly scheduled low-density lipoprotein cholesterol (LDL-C) apheresis, on reducing the need for future apheresis.

Key Dates

Start date
Dec 21, 2015
Status verified
Nov 2022
Primary completion
Sep 1, 2016
Completion
Jan 20, 2017

Study Design

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

Arms

  • Experimental: Evolocumab
    Participants received 140 mg evolocumab every 2 weeks (Q2W) administered by subcutaneous injection for 6 weeks during the primary period of the study. Starting at week 6 (beginning of the post-primary period), participants received 140 mg evolocumab Q2W up to week 24.
  • Active Comparator: Low Density Lipoprotein Cholesterol (LDL-C) Apheresis
    Participants continued apheresis at the same schedule, every week (QW) or every two weeks (Q2W), as prior to study entry, for the first 6 weeks. Starting at week 6 (beginning of the post-primary period), participants received 140 mg evolocumab Q2W up to week 24.

Primary Outcome Measure

Percentage of Participants With Apheresis Avoidance at the End of Randomized Therapy [ Time Frame: Week 5 and week 6 ]

Locations (4)

FacilityCityStateZIPSite coordinators
Research SiteBoca RatonFlorida33434-
Research SiteKansas CityKansas66160-
Research SiteGrandvilleMichigan49418-
Research SitePortlandOregon97239-

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By research site
Research Site· Boca Raton, FLResearch Site· Kansas City, KSResearch Site· Grandville, MIResearch Site· Portland, OR

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