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Trial record 37 of 153 for:    "familial hypercholesterolemia"

Study of Alirocumab (REGN727/SAR236553) in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) Undergoing Low-density Lipoprotein (LDL) Apheresis Therapy (ODYSSEY ESCAPE)

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ClinicalTrials.gov Identifier: NCT02326220
Recruitment Status : Completed
First Posted : December 29, 2014
Last Update Posted : February 7, 2017
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:
This is a randomized, double-blind, placebo-controlled, parallel-group study to evaluate the effect of alirocumab in comparison with placebo on the frequency of LDL apheresis treatments in patients with HeFH undergoing LDL apheresis therapy.

Condition or disease Intervention/treatment Phase
Heterozygous Familial Hypercholesterolemia Drug: Alirocumab Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia Undergoing Lipid Apheresis Therapy
Study Start Date : March 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Alirocumab

Arm Intervention/treatment
Experimental: Alirocumab
Alirocumab subcutaneous (SC) dose regimen
Drug: Alirocumab
Other Names:
  • REGN727
  • SAR236553

Placebo Comparator: Placebo
Placebo matching alirocumab subcutaneous (SC) dose regimen
Drug: Placebo



Primary Outcome Measures :
  1. Rate of apheresis treatments during a 12-week period normalized by the number of planned apheresis treatments according to each patient's established schedule at screening [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Percent change from baseline in low-density lipoprotein cholesterol (LDL-C) (pre-apheresis) [ Time Frame: Baseline to week 6 ]
  2. Standardized rate of apheresis treatments during a 4-week period [ Time Frame: 4 weeks ]
  3. Percent change from baseline in apolipoprotein B (ApoB) (pre-apheresis) (pre-apheresis) to week 6 [ Time Frame: Baseline to week 6 ]
  4. Percent change from baseline in non-high-density lipoprotein cholesterol (HDL-C) (pre-apheresis) [ Time Frame: Baseline to week 6 ]
  5. Percent change from baseline in total cholesterol (pre-apheresis) [ Time Frame: Baseline to week 6 ]
  6. Percent change from baseline in ApoA-1 (pre-apheresis) [ Time Frame: Baseline to week 6 ]
  7. Proportion of patients with ≥30% reduction in LDL-C (pre-apheresis) [ Time Frame: At week 6 ]
  8. Proportion of patients with ≥50% reduction in LDL-C (pre-apheresis) [ Time Frame: At week 6 ]
  9. Percent change from baseline in LDL-C (pre-apheresis) [ Time Frame: Baseline to week 18 ]
  10. Percent change from baseline in ApoB (pre-apheresis) [ Time Frame: Baseline to week 18 ]
  11. Percent change from baseline in non-HDL-C (pre-apheresis) to week 18 [ Time Frame: baseline to week 18 ]
  12. Percent change from baseline in total cholesterol (pre-apheresis) to week 18 [ Time Frame: baseline to week 18 ]
  13. Percent change from baseline in ApoA-1(pre-apheresis) to week 18 [ Time Frame: baseline to week 18 ]
  14. Proportion of patients with ≥30% reduction in LDL-C (pre-apheresis) at week 18 (pre-apheresis) [ Time Frame: At week 18 ]
  15. Proportion of patients with ≥50% reduction in LDL-C (pre-apheresis) at week 18 [ Time Frame: At week 18 ]
  16. Change of W-BQ22 (Well-Being Questionnaire 22-item version) from baseline to week 18 [ Time Frame: Baseline to week 18 ]
  17. Percent change from baseline in lipoprotein (a) [Lp(a)] (pre-apheresis) [ Time Frame: Baseline to week 6 ]
  18. Percent change from baseline in HDL-C (pre-apheresis) [ Time Frame: Baseline to week 6 ]
  19. Percent change from baseline in triglyceride (TG) levels (pre-apheresis) [ Time Frame: Baseline to week 6 ]
  20. Percent change from baseline in Lp(a) (pre-apheresis) to week 18 [ Time Frame: Baseline to week 18 ]
  21. Percent change from baseline in HDL-C (pre-apheresis) to week 18 [ Time Frame: Baseline to week 18 ]
  22. Percent change from baseline in TG levels (pre-apheresis) to week 18 [ Time Frame: Baseline to week 18 ]


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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:

  1. Men and women ≥18 years of age at the time of the screening visit
  2. Diagnosis of HeFH (Heterozygous familial hypercholesterolemia)
  3. Currently undergoing LDL (low-density lipoprotein) apheresis therapy QW (weekly) or Q2W (every 2 weeks) or at least 8 weeks prior to the screening visit

Exclusion Criteria:

  1. Homozygous FH (familial hypercholesterolemia)
  2. Background medical LMT (lipid-modifying therapy) (if applicable) that has not been stable for at least 8 weeks prior to the screening visit
  3. LDL apheresis schedule/ apheresis settings that have not been stable for at least 8 weeks prior to the screening visit
  4. An LDL apheresis schedule other than QW to Q2W
  5. Initiation of a new exercise program or exercise that has not remained stable within 8 weeks prior to the screening visit (week -2)
  6. Initiation of a new diet or a diet that has not been stable within 8 weeks prior to the screening visit (week -2)
  7. Use of nutraceuticals or over-the-counter therapies known to affect lipids, at a dose/amount that has not been stable for at least 8 weeks prior to the screening visit (week -2), or between the screening and randomization visit
  8. Presence of any clinically significant uncontrolled endocrine disease known to influence serum lipids or lipoproteins
  9. Known history of a positive test for human immunodeficiency virus
  10. Use of any active investigational drugs within 1 month or 5 half-lives of screening, whichever is longer
  11. Patients who have been treated with at least 1 dose of alirocumab or any other anti-PCSK9 monoclonal antibody in any other clinical studies
  12. Pregnant or breastfeeding women

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): NCT02326220


Locations
United States, Colorado
Aurora, Colorado, United States
United States, Connecticut
Hartford, Connecticut, United States
United States, Kansas
Kansas City, Kansas, United States
United States, Maine
Scarborough, Maine, United States
United States, Minnesota
Rochester, Minnesota, United States
United States, Oregon
Portland, Oregon, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
Germany
Dresden, Sachsen, Germany
Berlin, Germany
Goettlinger, Germany
Muenchen (2 locations), Germany
Passau, Germany
Rostock, Germany
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02326220     History of Changes
Other Study ID Numbers: R727-CL-1216
First Posted: December 29, 2014    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: October 2016

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipoproteinemia Type II
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs