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

Hypercholesterolemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02585895
• Other study ID #: 20140316
• Secondary ID: 2015-001343-37
• Status: Completed
• Phase: Phase 3
• Start date: December 21, 2015
• Est. completion date: January 20, 2017

Study information

• Verified date: November 2022
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: January 20, 2017
• Est. primary completion date: September 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

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.

Locations

Country	Name	City	State
Australia	Research Site	Heidelberg	Victoria
Czechia	Research Site	Hradec Kralove
France	Research Site	Bron
France	Research Site	Nantes Cedex 1
Germany	Research Site	Berlin
Germany	Research Site	Dresden
Germany	Research Site	Düsseldorf
Germany	Research Site	Flensburg
Italy	Research Site	Pisa
Italy	Research Site	Roma
Spain	Research Site	Sevilla	Andalucía
United Kingdom	Research Site	Harefield
United Kingdom	Research Site	Penarth
United States	Research Site	Boca Raton	Florida
United States	Research Site	Grandville	Michigan
United States	Research Site	Kansas City	Kansas
United States	Research Site	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Australia,  Czechia,  France,  Germany,  Italy,  Spain,  United Kingdom, 

References & Publications (1)

Baum SJ, Sampietro T, Datta D, Moriarty PM, Knusel B, Schneider J, Somaratne R, Kurtz C, Hohenstein B. Effect of evolocumab on lipoprotein apheresis requirement and lipid levels: Results of the randomized, controlled, open-label DE LAVAL study. J Clin Lipidol. 2019 Nov-Dec;13(6):901-909.e3. doi: 10.1016/j.jacl.2019.10.003. Epub 2019 Oct 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Apheresis Avoidance at the End of Randomized Therapy	Avoidance of apheresis at end of randomized therapy was defined as no apheresis at week 5 and week 6. Aperesis at weeks 5 or 6 was based on LDL-C level at week 4: participants with LDL-C = 100 mg/dL at week 4 received apheresis at week 5 (participants who received apheresis QW before study entry) or week 6 (participants who received apheresis Q2W prior to study entry). If LDL-C was < 100 mg/dL at week 4, no apheresis was performed at week 5 or week 6, irrespective of assigned treatment group.; Participants who ended the study prior to week 6 were considered as not achieving apheresis avoidance.	Week 5 and week 6
Secondary	Percent Change From Baseline in Low-density Lipoprotein Cholesterol		Baseline and week 4
Secondary	Percent Change From Baseline in Non-high-density Lipoprotein-Cholesterol		Baseline and Week 4
Secondary	Percent Change From Baseline in Total Cholesterol/High-density Lipoprotein Cholesterol Ratio		Baseline and Week 4

External Links

•   AmgenTrials clinical trials website