Back to resultsStudy of Alirocumab (REGN727/SAR236553) in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) Undergoing Low-density Lipoprotein (LDL) Apheresis Therapy (ODYSSEY ESCAPE)
Primary Purpose
Heterozygous Familial Hypercholesterolemia
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
Alirocumab
Sponsored by
About this trial
This is an interventional treatment trial for Heterozygous Familial Hypercholesterolemia
Eligibility Criteria
Inclusion Criteria:
- Men and women ≥18 years of age at the time of the screening visit
- Diagnosis of HeFH (Heterozygous familial hypercholesterolemia)
- 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:
- Homozygous FH (familial hypercholesterolemia)
- Background medical LMT (lipid-modifying therapy) (if applicable) that has not been stable for at least 8 weeks prior to the screening visit
- LDL apheresis schedule/ apheresis settings that have not been stable for at least 8 weeks prior to the screening visit
- An LDL apheresis schedule other than QW to Q2W
- Initiation of a new exercise program or exercise that has not remained stable within 8 weeks prior to the screening visit (week -2)
- Initiation of a new diet or a diet that has not been stable within 8 weeks prior to the screening visit (week -2)
- 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
- Presence of any clinically significant uncontrolled endocrine disease known to influence serum lipids or lipoproteins
- Known history of a positive test for human immunodeficiency virus
- Use of any active investigational drugs within 1 month or 5 half-lives of screening, whichever is longer
- Patients who have been treated with at least 1 dose of alirocumab or any other anti-PCSK9 monoclonal antibody in any other clinical studies
- Pregnant or breastfeeding women
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Placebo Q2W (Double Blind Period)
Alirocumab 150 mg Q2W (Double Blind Period)
Alirocumab 150 Q2W (Open Label Treatment Period)
Arm Description
Placebo (for alirocumab) subcutaneous (SC) injection Q2W up to Week 16.
Alirocumab 150 mg SC injection Q2W up to Week 16.
Alirocumab 150 mg SC injection Q2W starting from Week 18 up to Week 76.
Outcomes
Primary Outcome Measures
Change in Standardized Rate of Apheresis Treatments From Week 7 to Week 18
Rate of apheresis treatments were normalized by the number of planned apheresis treatments according to each participant's established schedule at screening, week -10 to week -2. The normalized rate of apheresis was defined for each participant as the number of actual apheresis treatments received from week 7 to week 18 divided by the number of planned apheresis treatments per randomization strata at baseline (6 for Q2W and 12 for QW).
Secondary Outcome Measures
Percent Change From Baseline in Calculated LDL-C (Pre-apheresis) at Week 6
Adjusted Least-squares (LS) means and standard errors at Week 6 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 2 to Week 18 regardless of status on or off-treatment were used in the model (ITT analysis).
Change in Standardized Rate of Apheresis Treatments From Week 15 to Week 18
Rate of apheresis treatments were normalized by the rate by the number of actual apheresis treatments according to received from week 15 to week 18 divided by the planned apheresis treatments per randomization strata at baseline (2 for Q2W and 4 for QW). Only legitimate apheresis treatment skipping per point-of-care LDL-C value is counted as "apheresis not occurred". Missing apheresis treatment information (any reason) from week 7 to week 18 is assigned an outcome of the apheresis treatment occurred at the visit (i.e. impute 1 apheresis treatment for that visit).
Percent Change From Baseline in Apolipoprotein B (Apo B) (Pre-apheresis) to Week 6
Adjusted LS means and standard errors at Week 6 were obtained from MMRM to account for missing data. All available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis).
Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) (Pre-apheresis) to Week 6
Adjusted LS means and standard errors at Week 6 were obtained from MMRM to account for missing data. All available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis).
Percent Change From Baseline in Total Cholesterol (Pre-apheresis) to Week 6
Adjusted LS means and standard errors at Week 6 were obtained from MMRM to account for missing data. All available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis).
Percent Change From Baseline in Apolipoprotein A (Apo A1) (Pre-apheresis) to Week 6
Adjusted LS means and standard errors at Week 6 were obtained from MMRM to account for missing data. All available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis).
Percentage of Participants With At Least (>=) 30% Reduction in Calculated LDL-C (Pre-apheresis) at Week 6
Percentage of participants at Week 6 was obtained from a last observation carried forward (LOCF) model for handling of missing data. All available post-baseline data regardless of status on- or off-treatment were used in the model (ITT analysis).
Percentage of Participants With At Least (>=) 50% Reduction in Calculated LDL-C (Pre-apheresis) at Week 6
Percentage of participants at Week 6 was obtained from LOCF model for handling of missing data. All available post-baseline data regardless of status on- or off-treatment were used in the model (ITT analysis).
Percent Change From Baseline in Calculated LDL-C (Pre-Apheresis) to Week 18
Adjusted LS means and standard errors at Week 18 were obtained from MMRM to account for missing data. All available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis).
Percent Change From Baseline in Apolipoprotein B (Apo B) (Pre-apheresis) to Week 18
Adjusted LS means and standard errors at Week 18 were obtained from MMRM to account for missing data. All available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis).
Percent Change From Baseline in Non-HDL-C (Pre-apheresis) to Week 18
Adjusted LS means and standard errors at Week 18 were obtained from MMRM to account for missing data. All available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis).
Percent Change From Baseline in Total Cholesterol (Pre-apheresis) to Week 18
Adjusted LS means and standard errors at Week 18 were obtained from MMRM to account for missing data. All available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis).
Percent Change From Baseline in Apo A1 (Pre-apheresis) to Week 18
Adjusted LS means and standard errors at Week 18 were obtained from MMRM to account for missing data. All available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis).
Percentage of Participants With At Least (>=) 30% Reduction in Calculated LDL-C (Pre-apheresis) at Week 18
Percentage of participants at Week 18 was obtained from LOCF model for handling of missing data. All available post-baseline data regardless of status on- or off-treatment were used in the model (ITT analysis).
Percentage of Participants With At Least (>=) 50% Reduction in Calculated LDL-C (Pre-apheresis) at Week 18
Percentage of participants at Week 18 was obtained from LOCF model for handling of missing data. All available post-baseline data regardless of status on- or off-treatment were used in the model (ITT analysis).
Change From Baseline in W-BQ22 (Well-being Questionnaire) Index Score at Week 18
The W-BQ22 (well-being) questionnaire was a standardized and generic instrument used for measuring the impact of hypercholesterolemia and treatment on well-being of participants. The general well-being score was calculated as the sum of 22 questions in the W-BQ22 questionnaire (each question scored from 0 to 3 [0 = not at all and 3 = all the time]). Total score for 22 questions range from 0 to 66 [0 = worst condition and 66 = best well-being condition).
Percent Change From Baseline in Lipoprotein (a) (Lp [a]) (Pre-apheresis) to Week 6
Adjusted means and standard errors at Week 6 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis).
Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) (Pre-apheresis) to Week 6
Adjusted LS means and standard errors at Week 6 were obtained from MMRM to account for missing data. All available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis).
Percent Change From Baseline in Triglyceride (TG) Levels (Pre-apheresis) to Week 6
Adjusted means and standard errors at Week 6 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis).
Percent Change From Baseline in Lp (a) (Pre-apheresis) to Week 18
Adjusted means and standard errors at Week 18 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis).
Percent Change From Baseline in HDL-C (Pre-apheresis) to Week 18
Adjusted LS means and standard errors at Week 18 were obtained from MMRM to account for missing data. All available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis).
Percent Change From Baseline in TG Levels (Pre-apheresis) to Week 18
Adjusted means and standard errors at Week 18 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis).
Full Information
NCT ID
NCT02326220
First Posted
December 22, 2014
Last Updated
April 21, 2020
Sponsor
Regeneron Pharmaceuticals
Collaborators
Sanofi
1. Study Identification
Unique Protocol Identification Number
NCT02326220
Brief Title
Study of Alirocumab (REGN727/SAR236553) in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) Undergoing Low-density Lipoprotein (LDL) Apheresis Therapy
Acronym
ODYSSEY ESCAPE
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 Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
March 31, 2015 (Actual)
Primary Completion Date
January 31, 2016 (Actual)
Study Completion Date
April 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals
Collaborators
Sanofi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary objective of the study is to evaluate the effect of alirocumab 150 mg every 2 weeks (Q2W) in comparison with placebo on the frequency of low-density lipoprotein (LDL) apheresis treatments in participants with heterozygous familial hypercholesterolemia (HeFH) undergoing weekly or bi-weekly LDL apheresis therapy.
Detailed Description
LDL apheresis removes low-density lipoproteins (LDL) that transport cholesterol in the plasma portion of the blood. This treatment is mainly used for familial hypercholesterolemia, but can be used in other rare diseases. Familial hypercholesterolemia (HeFH) is an inherited genetic condition that causes accumulation of cholesterol in the blood, which can lead to atherosclerosis and heart disease. This treatment is recommended for patients who do not respond to dietary and/or medication control of LDL cholesterol.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heterozygous Familial Hypercholesterolemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo Q2W (Double Blind Period)
Arm Type
Experimental
Arm Description
Placebo (for alirocumab) subcutaneous (SC) injection Q2W up to Week 16.
Arm Title
Alirocumab 150 mg Q2W (Double Blind Period)
Arm Type
Experimental
Arm Description
Alirocumab 150 mg SC injection Q2W up to Week 16.
Arm Title
Alirocumab 150 Q2W (Open Label Treatment Period)
Arm Type
Experimental
Arm Description
Alirocumab 150 mg SC injection Q2W starting from Week 18 up to Week 76.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Alirocumab
Other Intervention Name(s)
REGN727, SAR236553, Praluent®
Primary Outcome Measure Information:
Title
Change in Standardized Rate of Apheresis Treatments From Week 7 to Week 18
Description
Rate of apheresis treatments were normalized by the number of planned apheresis treatments according to each participant's established schedule at screening, week -10 to week -2. The normalized rate of apheresis was defined for each participant as the number of actual apheresis treatments received from week 7 to week 18 divided by the number of planned apheresis treatments per randomization strata at baseline (6 for Q2W and 12 for QW).
Time Frame
Week 7 to Week 18 (before start of open-label treatment)
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in Calculated LDL-C (Pre-apheresis) at Week 6
Description
Adjusted Least-squares (LS) means and standard errors at Week 6 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 2 to Week 18 regardless of status on or off-treatment were used in the model (ITT analysis).
Time Frame
Baseline and at Week 6
Title
Change in Standardized Rate of Apheresis Treatments From Week 15 to Week 18
Description
Rate of apheresis treatments were normalized by the rate by the number of actual apheresis treatments according to received from week 15 to week 18 divided by the planned apheresis treatments per randomization strata at baseline (2 for Q2W and 4 for QW). Only legitimate apheresis treatment skipping per point-of-care LDL-C value is counted as "apheresis not occurred". Missing apheresis treatment information (any reason) from week 7 to week 18 is assigned an outcome of the apheresis treatment occurred at the visit (i.e. impute 1 apheresis treatment for that visit).
Time Frame
Week 15 up to Week 18 (before the start of open-label treatment dose)
Title
Percent Change From Baseline in Apolipoprotein B (Apo B) (Pre-apheresis) to Week 6
Description
Adjusted LS means and standard errors at Week 6 were obtained from MMRM to account for missing data. All available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis).
Time Frame
From Baseline to Week 6
Title
Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) (Pre-apheresis) to Week 6
Description
Adjusted LS means and standard errors at Week 6 were obtained from MMRM to account for missing data. All available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis).
Time Frame
From Baseline to Week 6
Title
Percent Change From Baseline in Total Cholesterol (Pre-apheresis) to Week 6
Description
Adjusted LS means and standard errors at Week 6 were obtained from MMRM to account for missing data. All available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis).
Time Frame
From Baseline to Week 6
Title
Percent Change From Baseline in Apolipoprotein A (Apo A1) (Pre-apheresis) to Week 6
Description
Adjusted LS means and standard errors at Week 6 were obtained from MMRM to account for missing data. All available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis).
Time Frame
From Baseline to Week 6
Title
Percentage of Participants With At Least (>=) 30% Reduction in Calculated LDL-C (Pre-apheresis) at Week 6
Description
Percentage of participants at Week 6 was obtained from a last observation carried forward (LOCF) model for handling of missing data. All available post-baseline data regardless of status on- or off-treatment were used in the model (ITT analysis).
Time Frame
From Baseline to Week 6
Title
Percentage of Participants With At Least (>=) 50% Reduction in Calculated LDL-C (Pre-apheresis) at Week 6
Description
Percentage of participants at Week 6 was obtained from LOCF model for handling of missing data. All available post-baseline data regardless of status on- or off-treatment were used in the model (ITT analysis).
Time Frame
From Baseline to Week 6
Title
Percent Change From Baseline in Calculated LDL-C (Pre-Apheresis) to Week 18
Description
Adjusted LS means and standard errors at Week 18 were obtained from MMRM to account for missing data. All available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis).
Time Frame
From Baseline to Week 18
Title
Percent Change From Baseline in Apolipoprotein B (Apo B) (Pre-apheresis) to Week 18
Description
Adjusted LS means and standard errors at Week 18 were obtained from MMRM to account for missing data. All available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis).
Time Frame
From Baseline to Week 18
Title
Percent Change From Baseline in Non-HDL-C (Pre-apheresis) to Week 18
Description
Adjusted LS means and standard errors at Week 18 were obtained from MMRM to account for missing data. All available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis).
Time Frame
From Baseline to Week 18
Title
Percent Change From Baseline in Total Cholesterol (Pre-apheresis) to Week 18
Description
Adjusted LS means and standard errors at Week 18 were obtained from MMRM to account for missing data. All available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis).
Time Frame
From Baseline to Week 18
Title
Percent Change From Baseline in Apo A1 (Pre-apheresis) to Week 18
Description
Adjusted LS means and standard errors at Week 18 were obtained from MMRM to account for missing data. All available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis).
Time Frame
From Baseline to Week 18
Title
Percentage of Participants With At Least (>=) 30% Reduction in Calculated LDL-C (Pre-apheresis) at Week 18
Description
Percentage of participants at Week 18 was obtained from LOCF model for handling of missing data. All available post-baseline data regardless of status on- or off-treatment were used in the model (ITT analysis).
Time Frame
From Baseline to Week 18
Title
Percentage of Participants With At Least (>=) 50% Reduction in Calculated LDL-C (Pre-apheresis) at Week 18
Description
Percentage of participants at Week 18 was obtained from LOCF model for handling of missing data. All available post-baseline data regardless of status on- or off-treatment were used in the model (ITT analysis).
Time Frame
From Baseline to Week 18
Title
Change From Baseline in W-BQ22 (Well-being Questionnaire) Index Score at Week 18
Description
The W-BQ22 (well-being) questionnaire was a standardized and generic instrument used for measuring the impact of hypercholesterolemia and treatment on well-being of participants. The general well-being score was calculated as the sum of 22 questions in the W-BQ22 questionnaire (each question scored from 0 to 3 [0 = not at all and 3 = all the time]). Total score for 22 questions range from 0 to 66 [0 = worst condition and 66 = best well-being condition).
Time Frame
From Baseline to Week 18
Title
Percent Change From Baseline in Lipoprotein (a) (Lp [a]) (Pre-apheresis) to Week 6
Description
Adjusted means and standard errors at Week 6 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis).
Time Frame
From Baseline to Week 6
Title
Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) (Pre-apheresis) to Week 6
Description
Adjusted LS means and standard errors at Week 6 were obtained from MMRM to account for missing data. All available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis).
Time Frame
From Baseline to Week 6
Title
Percent Change From Baseline in Triglyceride (TG) Levels (Pre-apheresis) to Week 6
Description
Adjusted means and standard errors at Week 6 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis).
Time Frame
From Baseline to Week 6
Title
Percent Change From Baseline in Lp (a) (Pre-apheresis) to Week 18
Description
Adjusted means and standard errors at Week 18 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis).
Time Frame
From Baseline to Week 18
Title
Percent Change From Baseline in HDL-C (Pre-apheresis) to Week 18
Description
Adjusted LS means and standard errors at Week 18 were obtained from MMRM to account for missing data. All available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis).
Time Frame
From Baseline to Week 18
Title
Percent Change From Baseline in TG Levels (Pre-apheresis) to Week 18
Description
Adjusted means and standard errors at Week 18 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis).
Time Frame
From Baseline to Week 18
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men and women ≥18 years of age at the time of the screening visit
Diagnosis of HeFH (Heterozygous familial hypercholesterolemia)
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:
Homozygous FH (familial hypercholesterolemia)
Background medical LMT (lipid-modifying therapy) (if applicable) that has not been stable for at least 8 weeks prior to the screening visit
LDL apheresis schedule/ apheresis settings that have not been stable for at least 8 weeks prior to the screening visit
An LDL apheresis schedule other than QW to Q2W
Initiation of a new exercise program or exercise that has not remained stable within 8 weeks prior to the screening visit (week -2)
Initiation of a new diet or a diet that has not been stable within 8 weeks prior to the screening visit (week -2)
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
Presence of any clinically significant uncontrolled endocrine disease known to influence serum lipids or lipoproteins
Known history of a positive test for human immunodeficiency virus
Use of any active investigational drugs within 1 month or 5 half-lives of screening, whichever is longer
Patients who have been treated with at least 1 dose of alirocumab or any other anti-PCSK9 monoclonal antibody in any other clinical studies
Pregnant or breastfeeding women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Management
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
City
Aurora
State/Province
Colorado
Country
United States
City
Hartford
State/Province
Connecticut
Country
United States
City
Kansas City
State/Province
Kansas
Country
United States
City
Scarborough
State/Province
Maine
Country
United States
City
Rochester
State/Province
Minnesota
Country
United States
City
Portland
State/Province
Oregon
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Dresden
State/Province
Sachsen
Country
Germany
City
Berlin
Country
Germany
City
Göttingen
Country
Germany
City
Muenchen (2 locations)
Country
Germany
City
Passau
Country
Germany
City
Rostock
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
27572070
Citation
Moriarty PM, Parhofer KG, Babirak SP, Cornier MA, Duell PB, Hohenstein B, Leebmann J, Ramlow W, Schettler V, Simha V, Steinhagen-Thiessen E, Thompson PD, Vogt A, von Stritzky B, Du Y, Manvelian G. Alirocumab in patients with heterozygous familial hypercholesterolaemia undergoing lipoprotein apheresis: the ODYSSEY ESCAPE trial. Eur Heart J. 2016 Dec 21;37(48):3588-3595. doi: 10.1093/eurheartj/ehw388. Epub 2016 Aug 29.
Results Reference
background
PubMed Identifier
27206951
Citation
Moriarty PM, Parhofer KG, Babirak SP, deGoma E, Duell PB, Hohenstein B, Ramlow W, Simha V, Steinhagen-Thiessen E, Thompson PD, Vogt A, von Stritzky B, Du Y, Manvelian G. Alirocumab in patients with heterozygous familial hypercholesterolemia undergoing lipoprotein apheresis: Rationale and design of the ODYSSEY ESCAPE trial. J Clin Lipidol. 2016 May-Jun;10(3):627-34. doi: 10.1016/j.jacl.2016.02.003. Epub 2016 Feb 18.
Results Reference
derived
Learn more about this trial
Study of Alirocumab (REGN727/SAR236553) in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) Undergoing Low-density Lipoprotein (LDL) Apheresis Therapy
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