Evolocumab vs LDL Apheresis in participants with Hypercholesterolemia
Research type
Research Study
Full 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
IRAS ID
188923
Contact name
Mahmoud Barbir
Contact email
Sponsor organisation
Amgen Ltd
Eudract number
2015-001343-37
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 10 months, 2 days
Research summary
Lipoprotein apheresis lowers cholesterol approximately 50% to 75% with the goal of reducing cholesterol by at least 60% per apheresis session. However due to the rapid rebound in blood level cholesterol after each session, the averaged LDL-C reduction is considerably less than 60%.
In completed clinical studies, Evolocumab reduced LDL-C by approximately 55% to 75% and reduced LDL-C as early as week 1. Cholesterol lowering by medications like Evolocumab may reduce the need for Lipoprotein apheresis, which is invasive and only available in a few centres across the United Kingdom. It is not available in Northern Ireland or Scotland.
This study is designed to estimate the proportion of subjects on Lipoprotein apheresis who will be able to maintain cholesterol levels on receiving Evolocumab without continued apheresis, compared to patients who do not receive Evolocumab.
Patients who agree to participate in this study will be assessed to determine their eligibility for the study. 40 to 50 participants will receive either continued apheresis (weekly or biweekly) or stop apheresis and receive Evolocumab every 2 weeks for the first 6 weeks of the study. After that all participants will receive Evolocumab biweekly until week 22. If cholesterol levels are deemed high at week 4 or week 22 participants will receive rescue apheresis at weeks 5 or 6 and weeks 23 or 24 respectively. Final study procedures will occur at week 24 with a final safety follow up call at week 26.
During the study, participants will undergo a number of procedures; general and safety assessments (e.g. physical examination, adverse events, and concomitant medication collection), participant questionnaires, urine and blood tests. Subjects may also take part in an optional pharmacogenetic substudy (to evaluate differences in DNA that influence increased cholesterol and the response individuals have to same therapy).REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
15/EM/0522
Date of REC Opinion
15 Dec 2015
REC opinion
Further Information Favourable Opinion