Open Label Study of Long Term Safety Evaluation of Alirocumab
- Conditions
- Hypercholesterolemia
- Interventions
- Drug: AlirocumabDrug: Lipid-Modifying Therapy (LMT)
- Registration Number
- NCT01954394
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
To assess the long-term safety of alirocumab (SAR236553/REGN727) when added to lipid-lowering therapy in participants with heterozygous familial hypercholesterolemia (heFH) who had completed EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500), EFC12732 (NCT01617655) and LTS11717 (NCT01507831).
Secondary Objectives:
* To evaluate the long-term efficacy of alirocumab on lipid parameters.
* To evaluate the long-term immunogenicity of alirocumab.
- Detailed Description
The maximum study duration will be 176 weeks per participant.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 986
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Alirocumab 75 or 150 mg Q2W Lipid-Modifying Therapy (LMT) Alirocumab 75 mg or 150 mg every 2 weeks (Q2W) added to stable lipid-modifying therapy (LMT) for up to 168 additional weeks (or until the product was commercially available) in participants who completed the parent studies EFC12492, R727-CL-1112, EFC12732 and LTS11717. Alirocumab 75 or 150 mg Q2W Alirocumab Alirocumab 75 mg or 150 mg every 2 weeks (Q2W) added to stable lipid-modifying therapy (LMT) for up to 168 additional weeks (or until the product was commercially available) in participants who completed the parent studies EFC12492, R727-CL-1112, EFC12732 and LTS11717.
- Primary Outcome Measures
Name Time Method Percentage of Participants Who Experienced Adverse Events (AEs) Up to 10 weeks after last study drug administration (maximum of 176 weeks) Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study +70 days). Clinically significant lab and vital sign abnormalities were to be reported as AEs.
- Secondary Outcome Measures
Name Time Method Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168 Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168 Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Percent Change From Baseline in Fasting Triglycerides (TGs) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168 Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Absolute Change From Baseline in Apo B/Apo A-1 Ratio at Weeks 48, 96, 144, and 168 Parent Baseline, Weeks 48, 96, 144, and 168 Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Percent Change From Baseline in Calculated LDL-C at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168 Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Percentage of Participants With Calculated LDL-C <70 mg/dL (1.81mmol/L) and/or >=50% Reduction in Calculated LDL-C From Baseline (if Calculated LDL-C >=70 mg/dL [1.81mmol/L]) Over Time Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168 Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168 Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168 Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Percent Change From Baseline in Apolipoprotein-B (Apo-B) at Weeks 48, 96, 144, and 168 Parent Baseline, Weeks 48, 96, 144, and 168 Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Weeks 48, 96, 144, and 168 Parent Baseline, Weeks 48, 96, 144, and 168 Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168 Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168 Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Percent Change From Baseline in Total-cholesterol at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168 Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Percent Change From Baseline in Lipoprotein (a) at Weeks 48, 96, 144 and 168 Parent Baseline, Weeks 48, 96, 144, and 168 Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Trial Locations
- Locations (177)
Investigational Site Number 840321
🇺🇸Huntsville, Alabama, United States
Investigational Site Number 840334
🇺🇸Bell Gardens, California, United States
Investigational Site Number 840319
🇺🇸Fountain Valley, California, United States
Investigational Site Number 840337
🇺🇸Newport Beach, California, United States
Investigational Site Number 840339
🇺🇸Mission Viejo, California, United States
Investigational Site Number 840336
🇺🇸Los Angeles, California, United States
Investigational Site Number 840315
🇺🇸Evanston, Illinois, United States
Investigational Site Number 840305
🇺🇸Oakbrook Terrace, Illinois, United States
Investigational Site Number 840333
🇺🇸Iowa City, Iowa, United States
Investigational Site Number 840329
🇺🇸Kansas City, Kansas, United States
Investigational Site Number 840345
🇺🇸Auburn, Maine, United States
Investigational Site Number 840317
🇺🇸Saint Louis, Missouri, United States
Investigational Site Number 840349
🇺🇸Saint Louis, Missouri, United States
Investigational Site Number 840303
🇺🇸Charlotte, North Carolina, United States
Investigational Site Number 840316
🇺🇸New York, New York, United States
Investigational Site Number 840324
🇺🇸Poughkeepsie, New York, United States
Investigational Site Number 840348
🇺🇸Raleigh, North Carolina, United States
Investigational Site Number 840302
🇺🇸Marion, Ohio, United States
Investigational Site Number 840352
🇺🇸Beaver, Pennsylvania, United States
Investigational Site Number 840308
🇺🇸Philadelphia, Pennsylvania, United States
Investigational Site Number 840311
🇺🇸Dallas, Texas, United States
Investigational Site Number 840342
🇺🇸Scranton, Pennsylvania, United States
Investigational Site Number 840312
🇺🇸Dallas, Texas, United States
Investigational Site Number 840354
🇺🇸Chesapeake, Virginia, United States
Investigational Site Number 840301
🇺🇸Fort Worth, Texas, United States
Investigational Site Number 840350
🇺🇸Spokane, Washington, United States
Investigational Site Number 040302
🇦🇹Graz, Austria
Investigational Site Number 124302
🇨🇦Montreal, Canada
Investigational Site Number 203307
🇨🇿Hradec Kralove, Czechia
Investigational Site Number 203305
🇨🇿Praha 2, Czechia
Investigational Site Number 203303
🇨🇿Praha 8, Czechia
Investigational Site Number 203301
🇨🇿Praha 4, Czechia
Investigational Site Number 203306
🇨🇿Praha 5 - Motol, Czechia
Investigational Site Number 203309
🇨🇿Trutnov, Czechia
Investigational Site Number 203304
🇨🇿Uherske Hradiste, Czechia
Investigational Site Number 203302
🇨🇿Zlin, Czechia
Investigational Site Number 208306
🇩🇰Aarhus, Denmark
Investigational Site Number 246304
🇫🇮Vantaa, Finland
Investigational Site Number 250302
🇫🇷Nantes, France
Investigational Site Number 250306
🇫🇷Rennes, France
Investigational Site Number 276307
🇩🇪Witten, Germany
Investigational Site Number 376301
🇮🇱Tel Hashomer, Israel
Investigational Site Number 380303
🇮🇹Napoli, Italy
Investigational Site Number 380304
🇮🇹Milano, Italy
Investigational Site Number 484301
🇲🇽Mexico, Mexico
Investigational Site Number 528301
🇳🇱Amsterdam-Zuidoost, Netherlands
Investigational Site Number 528320
🇳🇱Apeldoorn, Netherlands
Investigational Site Number 620302
🇵🇹Funchal, Portugal
Investigational Site Number 643304
🇷🇺Arkhangelsk, Russian Federation
Investigational Site Number 643301
🇷🇺St Petersbourg, Russian Federation
Investigational Site Number 710311
🇿🇦Bellville, South Africa
Investigational Site Number 710307
🇿🇦Bloemfontein, South Africa
Investigational Site Number 710306
🇿🇦Cape Town, South Africa
Investigational Site Number 710309
🇿🇦Centurion, South Africa
Investigational Site Number 710302
🇿🇦Cape Town, South Africa
Investigational Site Number 710304
🇿🇦Parow, South Africa
Investigational Site Number 710313
🇿🇦Pretoria, South Africa
Investigational Site Number 710312
🇿🇦Parktown, South Africa
Investigational Site Number 710303
🇿🇦Pretoria, South Africa
Investigational Site Number 710305
🇿🇦Pretoria, South Africa
Investigational Site Number 710310
🇿🇦Somerset West, South Africa
Investigational Site Number 710314
🇿🇦Pretoria, South Africa
Investigational Site Number 710315
🇿🇦Roodepoort, South Africa
Investigational Site Number 710308
🇿🇦Witbank, South Africa
Investigational Site Number 724303
🇪🇸A Coruna, Spain
Investigational Site Number 724306
🇪🇸Córdoba, Spain
Investigational Site Number 724308
🇪🇸Barcelona, Spain
Investigational Site Number 724307
🇪🇸Hospitalet De Llobregat, Spain
Investigational Site Number 724312
🇪🇸Granada, Spain
Investigational Site Number 724301
🇪🇸Madrid, Spain
Investigational Site Number 724305
🇪🇸Madrid, Spain
Investigational Site Number 724311
🇪🇸Madrid, Spain
Investigational Site Number 724315
🇪🇸Quart De Poblet, Spain
Investigational Site Number 724309
🇪🇸Madrid, Spain
Investigational Site Number 724314
🇪🇸Málaga, Spain
Investigational Site Number 724310
🇪🇸Sabadell, Spain
Investigational Site Number 724302
🇪🇸Zaragoza, Spain
Investigational Site Number 724304
🇪🇸Tarragona, Spain
Investigational Site Number 724313
🇪🇸Sevilla, Spain
Investigational Site Number 826318
🇬🇧Birmingham, United Kingdom
Investigational Site Number 752304
🇸🇪Stockholm, Sweden
Investigational Site Number 752302
🇸🇪Goteborg, Sweden
Investigational Site Number 752301
🇸🇪Stockholm, Sweden
Investigational Site Number 826304
🇬🇧Brighton, United Kingdom
Investigational Site Number 826301
🇬🇧Bristol, United Kingdom
Investigational Site Number 826311
🇬🇧Cambridge, United Kingdom
Investigational Site Number 826310
🇬🇧Cardiff, United Kingdom
Investigational Site Number 826302
🇬🇧Dundee, United Kingdom
Investigational Site Number 826317
🇬🇧Liverpool, United Kingdom
Investigational Site Number 826306
🇬🇧Liverpool, United Kingdom
Investigational Site Number 826312
🇬🇧Manchester, United Kingdom
Investigational Site Number 826303
🇬🇧Manchester, United Kingdom
Investigational Site Number 826305
🇬🇧Middlesex, United Kingdom
Investigational Site Number 826315
🇬🇧West Bromwich, United Kingdom
Investigational Site Number 826313
🇬🇧Newcastle Upon Tyne, United Kingdom
Investigational Site Number 826316
🇬🇧West Bromwich, United Kingdom
Investigational Site Number 826309
🇬🇧Reading, United Kingdom
Investigational Site Number 056301
🇧🇪Natoye, Belgium
Investigational Site Number 100301
🇧🇬Sofia, Bulgaria
Investigational Site Number 124305
🇨🇦Toronto, Canada
Investigational Site Number 840341
🇺🇸Tempe, Arizona, United States
Investigational Site Number 840353
🇺🇸Clearwater, Florida, United States
Investigational Site Number 840328
🇺🇸Washington, District of Columbia, United States
Investigational Site Number 032302
🇦🇷Caba, Argentina
Investigational Site Number 040303
🇦🇹Sankt Stefan, Austria
Investigational Site Number 040301
🇦🇹Wien, Austria
Investigational Site Number 840344
🇺🇸Atlantis, Florida, United States
Investigational Site Number 840318
🇺🇸Fort Lauderdale, Florida, United States
Investigational Site Number 840346
🇺🇸Framingham, Massachusetts, United States
Investigational Site Number 840322
🇺🇸Boston, Massachusetts, United States
Investigational Site Number 840327
🇺🇸Jacksonville, Florida, United States
Investigational Site Number 840304
🇺🇸Summerville, South Carolina, United States
Investigational Site Number 840351
🇺🇸Sarasota, Florida, United States
Investigational Site Number 840338
🇺🇸Biddeford, Maine, United States
Investigational Site Number 840314
🇺🇸Morristown, New Jersey, United States
Investigational Site Number 840343
🇺🇸Bountiful, Utah, United States
Investigational Site Number 124303
🇨🇦Chicoutimi, Canada
Investigational Site Number 124301
🇨🇦Quebec, Canada
Investigational Site Number 124306
🇨🇦Sherbrooke, Canada
Investigational Site Number 032301
🇦🇷Coronel Suarez, Argentina
Investigational Site Number 100302
🇧🇬Sofia, Bulgaria
Investigational Site Number 124304
🇨🇦Victoria, Canada
Investigational Site Number 246302
🇫🇮Joensuu, Finland
Investigational Site Number 246301
🇫🇮Kokkola, Finland
Investigational Site Number 250303
🇫🇷Dijon, France
Investigational Site Number 250304
🇫🇷Lille Cedex, France
Investigational Site Number 376304
🇮🇱Jerusalem, Israel
Investigational Site Number 250301
🇫🇷Paris, France
Investigational Site Number 250305
🇫🇷Pessac, France
Investigational Site Number 276305
🇩🇪Frankfurt A.M., Germany
Investigational Site Number 276301
🇩🇪Magdeburg, Germany
Investigational Site Number 348301
🇭🇺Baja, Hungary
Investigational Site Number 380302
🇮🇹Chieti, Italy
Investigational Site Number 528317
🇳🇱Alkmaar, Netherlands
Investigational Site Number 528319
🇳🇱Enschede, Netherlands
Investigational Site Number 528313
🇳🇱Eindhoven, Netherlands
Investigational Site Number 528302
🇳🇱Groningen, Netherlands
Investigational Site Number 276302
🇩🇪Berlin, Germany
Investigational Site Number 276306
🇩🇪Leipzig, Germany
Investigational Site Number 376302
🇮🇱Holon, Israel
Investigational Site Number 380301
🇮🇹Palermo, Italy
Investigational Site Number 578305
🇳🇴Oslo, Norway
Investigational Site Number 376303
🇮🇱Safed, Israel
Investigational Site Number 528309
🇳🇱Delfzijl, Netherlands
Investigational Site Number 528322
🇳🇱Goes, Netherlands
Investigational Site Number 528321
🇳🇱Venlo, Netherlands
Investigational Site Number 528316
🇳🇱Waalwijk, Netherlands
Investigational Site Number 578301
🇳🇴Bodo, Norway
Investigational Site Number 528303
🇳🇱Utrecht, Netherlands
Investigational Site Number 528325
🇳🇱Groningen, Netherlands
Investigational Site Number 528324
🇳🇱Hoogeveen, Netherlands
Investigational Site Number 528318
🇳🇱Hoorn, Netherlands
Investigational Site Number 528305
🇳🇱Leiden, Netherlands
Investigational Site Number 528311
🇳🇱Maastricht, Netherlands
Investigational Site Number 528312
🇳🇱Nijmegen, Netherlands
Investigational Site Number 528315
🇳🇱Rotterdam, Netherlands
Investigational Site Number 528326
🇳🇱Rotterdam, Netherlands
Investigational Site Number 528323
🇳🇱Utrecht, Netherlands
Investigational Site Number 620301
🇵🇹Lisboa, Portugal
Investigational Site Number 643302
🇷🇺Moscow, Russian Federation
Investigational Site Number 643305
🇷🇺Moscow, Russian Federation
Investigational Site Number 578304
🇳🇴Oslo, Norway
Investigational Site Number 642302
🇷🇴Timisoara, Romania
Investigational Site Number 643303
🇷🇺Kazan, Russian Federation
Investigational Site Number 643308
🇷🇺Moscow, Russian Federation
Investigational Site Number 643310
🇷🇺Novosibirsk, Russian Federation
Investigational Site Number 643306
🇷🇺St. Petersburg, Russian Federation
Investigational Site Number 643312
🇷🇺St.Petersburg, Russian Federation
Investigational Site Number 840306
🇺🇸Golden, Colorado, United States
Investigational Site Number 208301
🇩🇰Aalborg, Denmark
Investigational Site Number 208302
🇩🇰Esbjerg, Denmark
Investigational Site Number 208303
🇩🇰Roskilde, Denmark
Investigational Site Number 208304
🇩🇰Svendborg, Denmark
Investigational Site Number 840309
🇺🇸Miami, Florida, United States
Investigational Site Number 840320
🇺🇸Durham, North Carolina, United States
Investigational Site Number 840340
🇺🇸Cincinnati, Ohio, United States
Investigational Site Number 840330
🇺🇸Portland, Oregon, United States