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Trial record 1 of 1 for:    20140316
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Evolocumab Compared to LDL-C Apheresis in Patients Receiving LDL-C Apheresis Prior to Study Enrollment

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ClinicalTrials.gov Identifier: NCT02585895
Recruitment Status : Completed
First Posted : October 26, 2015
Results First Posted : September 19, 2017
Last Update Posted : September 19, 2017
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief 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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Biological: Evolocumab Procedure: Low-density Lipoprotein Cholesterol (LDL-C) Apheresis Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 21, 2015
Actual Primary Completion Date : September 1, 2016
Actual Study Completion Date : January 20, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Evolocumab

Arm Intervention/treatment
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.
Biological: Evolocumab
Administered by subcutaneous injection once every 2 weeks
Other Names:
  • Repatha
  • AMG 145

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.
Biological: Evolocumab
Administered by subcutaneous injection once every 2 weeks
Other Names:
  • Repatha
  • AMG 145

Procedure: Low-density Lipoprotein Cholesterol (LDL-C) Apheresis
Participants received apheresis for LDL-C according the their physician's prescription and local custom.




Primary Outcome Measures :
  1. Percentage of Participants With Apheresis Avoidance at the End of Randomized Therapy [ Time Frame: Week 5 and week 6 ]

    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.



Secondary Outcome Measures :
  1. Percent Change From Baseline in Low-density Lipoprotein Cholesterol [ Time Frame: Baseline and week 4 ]
  2. Percent Change From Baseline in Non-high-density Lipoprotein-Cholesterol [ Time Frame: Baseline and Week 4 ]
  3. Percent Change From Baseline in Total Cholesterol/High-density Lipoprotein Cholesterol Ratio [ Time Frame: Baseline and Week 4 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02585895


Locations
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United States, Florida
Research Site
Boca Raton, Florida, United States, 33434
United States, Kansas
Research Site
Kansas City, Kansas, United States, 66160
United States, Michigan
Research Site
Grandville, Michigan, United States, 49418
United States, Oregon
Research Site
Portland, Oregon, United States, 97239
Australia, Victoria
Research Site
Heidelberg, Victoria, Australia, 3084
Czechia
Research Site
Hradec Kralove, Czechia, 500 05
France
Research Site
Bron, France, 69677
Research Site
Nantes Cedex 1, France, 44093
Germany
Research Site
Berlin, Germany, 13353
Research Site
Dresden, Germany, 01307
Research Site
Düsseldorf, Germany, 40210
Research Site
Flensburg, Germany, 24939
Italy
Research Site
Pisa, Italy, 56124
Research Site
Roma, Italy, 00161
Spain
Research Site
Sevilla, Andalucía, Spain, 41013
United Kingdom
Research Site
Harefield, United Kingdom, UB9 6JH
Research Site
Penarth, United Kingdom, CF64 2XX
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen

Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02585895    
Other Study ID Numbers: 20140316
2015-001343-37 ( EudraCT Number )
First Posted: October 26, 2015    Key Record Dates
Results First Posted: September 19, 2017
Last Update Posted: September 19, 2017
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amgen:
LDL-C Apheresis
Hypercholesterolemia
Elevated Cholesterol
High Cholesterol
PCSK9 mutations
Severe Familial Hypercholesterolemia
evolocumab
Repatha
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Evolocumab
Antibodies, Monoclonal
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Immunologic Factors
Physiological Effects of Drugs