Overview

This trial is active, not recruiting.

Condition hypercholesterolemia
Treatments evolocumab (amg 145), low density lipoprotein cholesterol (ldl-c) apheresis
Phase phase 3
Sponsor Amgen
Start date December 2015
End date September 2016
Trial size 39 participants
Trial identifier NCT02585895, 20140316, 2015-001343-37

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Subject will receive evolocumab (AMG 145) every 2 weeks (Q2W)
evolocumab (amg 145) Repatha
Administered by subcutaneous injection
(Other)
Subjects will continue apheresis at the same schedule, every week (QW) or every two weeks (Q2W), as prior to study entry, for the first 6 weeks
low density lipoprotein cholesterol (ldl-c) apheresis
Subjects will continue apheresis at the same schedule, every week or every two weeks, as prior to study entry

Primary Outcomes

Measure
Apheresis avoidance at the end of randomized therapy, defined as no apheresis at week 5 and week 6
time frame: Week 5
Apheresis avoidance at the end of randomized therapy, defined as no apheresis at week 5 and week 6
time frame: Week 6

Secondary Outcomes

Measure
Percent change from baseline in low density lipoprotein-cholesterol
time frame: Week 4
Percent change from baseline in non-high density lipoprotein-cholesterol
time frame: Week 4
Percent change from baseline in total cholesterol/high density lipoprotein-cholesterol ratio
time frame: Week 4

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 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. Exclusion criteria: - 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

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Amgen.