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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02585895




Registration number
NCT02585895
Ethics application status
Date submitted
7/10/2015
Date registered
26/10/2015

Titles & IDs
Public title
Evolocumab Compared to LDL-C Apheresis in Patients Receiving LDL-C Apheresis Prior to Study Enrollment
Scientific 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
Secondary ID [1] 0 0
2015-001343-37
Secondary ID [2] 0 0
20140316
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypercholesterolemia 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Evolocumab
Treatment: Surgery - Low-density Lipoprotein Cholesterol (LDL-C) Apheresis

Experimental: Evolocumab - Participants received 140 mg evolocumab every 2 weeks (Q2W) administered by subcutaneous injection for 6 weeks during the primary period of the study. Starting at week 6 (beginning of the post-primary period), participants received 140 mg evolocumab Q2W up to week 24.

Active comparator: Low Density Lipoprotein Cholesterol (LDL-C) Apheresis - Participants continued apheresis at the same schedule, every week (QW) or every two weeks (Q2W), as prior to study entry, for the first 6 weeks. Starting at week 6 (beginning of the post-primary period), participants received 140 mg evolocumab Q2W up to week 24.


Treatment: Other: Evolocumab
Administered by subcutaneous injection once every 2 weeks

Treatment: Surgery: Low-density Lipoprotein Cholesterol (LDL-C) Apheresis
Participants received apheresis for LDL-C according the their physician's prescription and local custom.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Apheresis Avoidance at the End of Randomized Therapy
Timepoint [1] 0 0
Week 5 and week 6
Secondary outcome [1] 0 0
Percent Change From Baseline in Low-density Lipoprotein Cholesterol
Timepoint [1] 0 0
Baseline and week 4
Secondary outcome [2] 0 0
Percent Change From Baseline in Non-high-density Lipoprotein-Cholesterol
Timepoint [2] 0 0
Baseline and Week 4
Secondary outcome [3] 0 0
Percent Change From Baseline in Total Cholesterol/High-density Lipoprotein Cholesterol Ratio
Timepoint [3] 0 0
Baseline and Week 4

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/12/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/01/2017
Sample size
Target
Accrual to date
Final
39
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Research Site - Heidelberg
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Kansas
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
Oregon
Country [5] 0 0
Czechia
State/province [5] 0 0
Hradec Kralove
Country [6] 0 0
France
State/province [6] 0 0
Bron
Country [7] 0 0
France
State/province [7] 0 0
Nantes Cedex 1
Country [8] 0 0
Germany
State/province [8] 0 0
Berlin
Country [9] 0 0
Germany
State/province [9] 0 0
Dresden
Country [10] 0 0
Germany
State/province [10] 0 0
Düsseldorf
Country [11] 0 0
Germany
State/province [11] 0 0
Flensburg
Country [12] 0 0
Italy
State/province [12] 0 0
Pisa
Country [13] 0 0
Italy
State/province [13] 0 0
Roma
Country [14] 0 0
Spain
State/province [14] 0 0
Andalucía
Country [15] 0 0
United Kingdom
State/province [15] 0 0
Harefield
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Penarth

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02585895