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NCT01954394 Clinical Trial

Open Label Study of Long Term Safety Evaluation of Alirocumab

Hypercholesterolemia Clinical Trial

— ODYSSEY OLE  

Official title:
Open-Label Extension Study of EFC12492, R727-CL-1112, EFC12732 and LTS11717 Studies to Assess the Long-Term Safety and Efficacy of Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01954394
Other study ID # LTS13463
Secondary ID 2013-002572-40U1
Status Completed
Phase Phase 3
First received
Last updated
Start date December 17, 2013
Est. completion date June 30, 2017

Study information
Verified date June 2018
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

The maximum study duration will be 176 weeks per participant.

Recruitment information / eligibility
Status Completed
Enrollment 986
Est. completion date June 30, 2017
Est. primary completion date June 30, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria:

Participants with heFH who had completed one of the four parent studies (EFC12492, R727-CL-1112, EFC12732 and LTS11717).

Exclusion criteria:

Significant protocol deviation in the parent study; Any permanent treatment discontinuation from the parent study.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Alirocumab
Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a pre-filled syringe.
• Lipid-Modifying Therapy (LMT)
Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose with or without other LMT as clinically indicated.

Locations
Country Name City State
Argentina Investigational Site Number 032302 Caba
Argentina Investigational Site Number 032301 Coronel Suarez
Austria Investigational Site Number 040302 Graz
Austria Investigational Site Number 040303 Sankt Stefan
Austria Investigational Site Number 040301 Wien
Belgium Investigational Site Number 056301 Natoye
Bulgaria Investigational Site Number 100301 Sofia
Bulgaria Investigational Site Number 100302 Sofia
Canada Investigational Site Number 124303 Chicoutimi
Canada Investigational Site Number 124302 Montreal
Canada Investigational Site Number 124301 Quebec
Canada Investigational Site Number 124306 Sherbrooke
Canada Investigational Site Number 124305 Toronto
Canada Investigational Site Number 124304 Victoria
Czechia Investigational Site Number 203307 Hradec Kralove
Czechia Investigational Site Number 203305 Praha 2
Czechia Investigational Site Number 203301 Praha 4
Czechia Investigational Site Number 203306 Praha 5 - Motol
Czechia Investigational Site Number 203303 Praha 8
Czechia Investigational Site Number 203309 Trutnov
Czechia Investigational Site Number 203304 Uherske Hradiste
Czechia Investigational Site Number 203302 Zlin
Denmark Investigational Site Number 208301 Aalborg
Denmark Investigational Site Number 208306 Aarhus
Denmark Investigational Site Number 208302 Esbjerg
Denmark Investigational Site Number 208303 Roskilde
Denmark Investigational Site Number 208304 Svendborg
Finland Investigational Site Number 246302 Joensuu
Finland Investigational Site Number 246301 Kokkola
Finland Investigational Site Number 246304 Vantaa
France Investigational Site Number 250303 Dijon
France Investigational Site Number 250304 Lille Cedex
France Investigational Site Number 250302 Nantes
France Investigational Site Number 250301 Paris
France Investigational Site Number 250305 Pessac
France Investigational Site Number 250306 Rennes
Germany Investigational Site Number 276302 Berlin
Germany Investigational Site Number 276305 Frankfurt A.M.
Germany Investigational Site Number 276306 Leipzig
Germany Investigational Site Number 276301 Magdeburg
Germany Investigational Site Number 276307 Witten
Hungary Investigational Site Number 348301 Baja
Israel Investigational Site Number 376302 Holon
Israel Investigational Site Number 376304 Jerusalem
Israel Investigational Site Number 376303 Safed
Israel Investigational Site Number 376301 Tel Hashomer
Italy Investigational Site Number 380302 Chieti
Italy Investigational Site Number 380304 Milano
Italy Investigational Site Number 380303 Napoli
Italy Investigational Site Number 380301 Palermo
Mexico Investigational Site Number 484301 Mexico
Netherlands Investigational Site Number 528317 Alkmaar
Netherlands Investigational Site Number 528301 Amsterdam-Zuidoost
Netherlands Investigational Site Number 528320 Apeldoorn
Netherlands Investigational Site Number 528309 Delfzijl
Netherlands Investigational Site Number 528313 Eindhoven
Netherlands Investigational Site Number 528319 Enschede
Netherlands Investigational Site Number 528322 Goes
Netherlands Investigational Site Number 528302 Groningen
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 528303 Utrecht
Netherlands Investigational Site Number 528323 Utrecht
Netherlands Investigational Site Number 528321 Venlo
Netherlands Investigational Site Number 528316 Waalwijk
Norway Investigational Site Number 578301 Bodo
Norway Investigational Site Number 578304 Oslo
Norway Investigational Site Number 578305 Oslo
Portugal Investigational Site Number 620302 Funchal
Portugal Investigational Site Number 620301 Lisboa
Romania Investigational Site Number 642302 Timisoara
Russian Federation Investigational Site Number 643304 Arkhangelsk
Russian Federation Investigational Site Number 643303 Kazan
Russian Federation Investigational Site Number 643302 Moscow
Russian Federation Investigational Site Number 643305 Moscow
Russian Federation Investigational Site Number 643308 Moscow
Russian Federation Investigational Site Number 643310 Novosibirsk
Russian Federation Investigational Site Number 643301 St Petersbourg
Russian Federation Investigational Site Number 643306 St. Petersburg
Russian Federation Investigational Site Number 643312 St.Petersburg
South Africa Investigational Site Number 710311 Bellville
South Africa Investigational Site Number 710307 Bloemfontein
South Africa Investigational Site Number 710302 Cape Town
South Africa Investigational Site Number 710306 Cape Town
South Africa Investigational Site Number 710309 Centurion
South Africa Investigational Site Number 710312 Parktown
South Africa Investigational Site Number 710304 Parow
South Africa Investigational Site Number 710303 Pretoria
South Africa Investigational Site Number 710305 Pretoria
South Africa Investigational Site Number 710313 Pretoria
South Africa Investigational Site Number 710314 Pretoria
South Africa Investigational Site Number 710315 Roodepoort
South Africa Investigational Site Number 710310 Somerset West
South Africa Investigational Site Number 710308 Witbank
Spain Investigational Site Number 724303 A Coruna
Spain Investigational Site Number 724308 Barcelona
Spain Investigational Site Number 724306 Córdoba
Spain Investigational Site Number 724312 Granada
Spain Investigational Site Number 724307 Hospitalet De Llobregat
Spain Investigational Site Number 724301 Madrid
Spain Investigational Site Number 724305 Madrid
Spain Investigational Site Number 724309 Madrid
Spain Investigational Site Number 724311 Madrid
Spain Investigational Site Number 724314 Málaga
Spain Investigational Site Number 724315 Quart De Poblet
Spain Investigational Site Number 724310 Sabadell
Spain Investigational Site Number 724313 Sevilla
Spain Investigational Site Number 724304 Tarragona
Spain Investigational Site Number 724302 Zaragoza
Sweden Investigational Site Number 752302 Goteborg
Sweden Investigational Site Number 752301 Stockholm
Sweden Investigational Site Number 752304 Stockholm
United Kingdom Investigational Site Number 826318 Birmingham
United Kingdom 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 826306 Liverpool
United Kingdom Investigational Site Number 826317 Liverpool
United Kingdom Investigational Site Number 826303 Manchester
United Kingdom Investigational Site Number 826312 Manchester
United Kingdom Investigational Site Number 826305 Middlesex
United Kingdom Investigational Site Number 826313 Newcastle Upon Tyne
United Kingdom Investigational Site Number 826309 Reading
United Kingdom Investigational Site Number 826315 West Bromwich
United Kingdom Investigational Site Number 826316 West Bromwich
United States Investigational Site Number 840344 Atlantis Florida
United States Investigational Site Number 840345 Auburn Maine
United States Investigational Site Number 840352 Beaver Pennsylvania
United States Investigational Site Number 840334 Bell Gardens California
United States Investigational Site Number 840338 Biddeford Maine
United States Investigational Site Number 840322 Boston Massachusetts
United States Investigational Site Number 840343 Bountiful Utah
United States Investigational Site Number 840303 Charlotte North Carolina
United States Investigational Site Number 840354 Chesapeake Virginia
United States Investigational Site Number 840340 Cincinnati Ohio
United States Investigational Site Number 840353 Clearwater Florida
United States Investigational Site Number 840311 Dallas Texas
United States Investigational Site Number 840312 Dallas Texas
United States Investigational Site Number 840320 Durham North Carolina
United States Investigational Site Number 840315 Evanston Illinois
United States Investigational Site Number 840318 Fort Lauderdale Florida
United States Investigational Site Number 840301 Fort Worth Texas
United States Investigational Site Number 840319 Fountain Valley California
United States Investigational Site Number 840346 Framingham Massachusetts
United States Investigational Site Number 840306 Golden Colorado
United States Investigational Site Number 840321 Huntsville Alabama
United States Investigational Site Number 840333 Iowa City Iowa
United States Investigational Site Number 840327 Jacksonville Florida
United States Investigational Site Number 840329 Kansas City Kansas
United States Investigational Site Number 840336 Los Angeles California
United States Investigational Site Number 840302 Marion Ohio
United States Investigational Site Number 840309 Miami Florida
United States Investigational Site Number 840339 Mission Viejo California
United States Investigational Site Number 840314 Morristown New Jersey
United States Investigational Site Number 840316 New York New York
United States Investigational Site Number 840337 Newport Beach California
United States Investigational Site Number 840305 Oakbrook Terrace Illinois
United States Investigational Site Number 840308 Philadelphia Pennsylvania
United States Investigational Site Number 840330 Portland Oregon
United States Investigational Site Number 840324 Poughkeepsie New York
United States Investigational Site Number 840348 Raleigh North Carolina
United States Investigational Site Number 840317 Saint Louis Missouri
United States Investigational Site Number 840349 Saint Louis Missouri
United States Investigational Site Number 840351 Sarasota Florida
United States Investigational Site Number 840342 Scranton Pennsylvania
United States Investigational Site Number 840350 Spokane Washington
United States Investigational Site Number 840304 Summerville South Carolina
United States Investigational Site Number 840341 Tempe Arizona
United States Investigational Site Number 840328 Washington District of Columbia

Sponsors (2)
Lead Sponsor Collaborator
Sanofi Regeneron Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Belgium,  Bulgaria,  Canada,  Czechia,  Denmark,  Finland,  France,  Germany,  Hungary,  Israel,  Italy,  Mexico,  Netherlands,  Norway,  Portugal,  Romania,  Russian Federation,  South Africa,  Spain,  Sweden,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of Participants Who Experienced Adverse Events (AEs) 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. Up to 10 weeks after last study drug administration (maximum of 176 weeks)
Secondary Percent Change From Baseline in Calculated LDL-C at 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. Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168
Secondary Absolute Change From Baseline in Calculated LDL-C (mg/dL) at 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. Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168
Secondary Absolute Change From Baseline in Calculated LDL-C (mmol/L) at 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. Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168
Secondary Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time 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. Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168
Secondary Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time 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. Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168
Secondary 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 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. Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168
Secondary Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at 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. Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168
Secondary Percent Change From Baseline in Total-cholesterol at 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. Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168
Secondary Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at 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. Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168
Secondary Percent Change From Baseline in Fasting Triglycerides (TGs) at 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. Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168
Secondary Percent Change From Baseline in Lipoprotein (a) at 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. Parent Baseline, Weeks 48, 96, 144, and 168
Secondary Percent Change From Baseline in Apolipoprotein-B (Apo-B) at 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. Parent Baseline, Weeks 48, 96, 144, and 168
Secondary Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at 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. Parent Baseline, Weeks 48, 96, 144, and 168
Secondary Absolute Change From Baseline in Apo B/Apo A-1 Ratio at 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. Parent Baseline, Weeks 48, 96, 144, and 168
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