NCT02585895

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

A Randomized, Actively Controlled, Open-label, Multicenter Study of Efficacy and Safety of Evolocumab Compared With Low Density Lipoprotein Cholesterol (LDL-C) Apheresis, Followed by Single-Arm Evolocumab Administration in Subjects Receiving LDL-C Apheresis Prior to Study Enrollment

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hypercholesterolemia

Interventions

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

Timeline

• Start date: 2015-12-21
• Primary completion: 2016-09-01
• Completion: 2017-01-20
• First posted: 2015-10-26
• Last updated: 2022-11-30
• Results posted: 2017-09-19

Locations

17 sites across 8 countries: United States, Australia, Czechia, France, Germany, Italy, Spain, United Kingdom

Regulatory

• FDA-regulated drug study