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

Completed · Phase 3

Conditions studied: Hypercholesterolemia

In brief

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 facts

Study ID

NCT02585895

Run by

Amgen

People needed

39

Starts

2015-12-21

Expected to finish

2017-01-20

Last updated by the study team

2022-11-30

Who can join

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

You may qualify if…

• Male or female, ≥ 18 years of age
• Subject has been receiving regular apheresis for LDL-C lowering for at least 3 months immediately prior to lipid screening and has a treatment goal of LDL-C < 100 mg/dL (2.6 mmol/L), and has been receiving LDL-C apheresis during the last ≥ 4 weeks prior to lipid screening at regular QW or Q2W schedule and with no changes in apheresis type
• Subject is receiving lipid-lowering pharmacological background therapy which includes a high-intensity statin dose (moderate-intensity statin dose with attestation that a higher dose is not appropriate for the subject) unless the subject has a history of statin intolerance
• Lipid-lowering therapy status (ie, any therapy for lowering lipids, including apheresis type and frequency) must be unchanged for ≥ 4 weeks prior to LDL-C screening
• Pre-apheresis LDL-C is ≥ 100 mg/dL (≥ 2.6 mmol/L) and ≤ 190 mg/dL (≤ 4.9 mmol/L) at screening
• Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L) at screening.

You may not qualify if…

• Known homozygous familial hypercholesterolemia
• Missing any apheresis session is medically contraindicated or inappropriate
• Stopping apheresis would be inappropriate in the opinion of the investigator even if LDL-C is controlled to < 100 mg/dL with other therapies
• Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization.
• Uncontrolled hypertension

Where it is running

• Research Site — Boca Raton, Florida, United States
• Research Site — Kansas City, Kansas, United States
• Research Site — Grandville, Michigan, United States
• Research Site — Portland, Oregon, United States
• Research Site — Heidelberg, Victoria, Australia
• Research Site — Hradec Králové, Czechia
• Research Site — Bron, France
• Research Site — Nantes, France
• Research Site — Berlin, Germany
• Research Site — Dresden, Germany
• Research Site — Düsseldorf, Germany
• Research Site — Flensburg, Germany
• Research Site — Pisa, Italy
• Research Site — Roma, Italy
• Research Site — Seville, Andalusia, Spain
• Research Site — Harefield, United Kingdom
• Research Site — Penarth, United Kingdom

Full record on ClinicalTrials.gov

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