Study Description
The purpose of this open-label, single arm, multicenter extension study is to evaluate the long-term safety and tolerability of inclisiran in participants with HeFH or HoFH who have completed the ORION-16 or ORION-13 studies.
This is an open-label, single arm, multicenter study designed to evaluate long-term safety and tolerability of inclisiran. In addition, the study will provide participants the opportunity to have continued access to treatment with inclisiran.
Interventions
Inclisiran
Eligibility Criteria
Key inclusion:
Male and female participants with a diagnosis of HeFH or HoFH who completed the ORION-16 or ORION-13 studies
Per investigator's clinical judgment, participant derived benefit from treatment with inclisiran in the ORION-16 or ORION-13 studies
Key exclusion:
Participants who in the feeder inclisiran ORION-16 and ORION-13 studies either screen failed or permanently discontinued from the treatment/study for any reason or had serious safety or tolerability issues related to inclisiran treatment
Any uncontrolled or serious disease, or any medical, physical, or surgical condition, that may either interfere with participation in the clinical study or interpretation of clinical study results, and/or put the participant at significant risk
Study Location
Novartis Investigative Site
Recruiting
Fortaleza,Ceara,60430275,Brazil
Novartis Investigative Site
Recruiting
Sao Paulo,SP,04023-900,Brazil
Novartis Investigative Site
Recruiting
Sao Paulo,SP,05403 000,Brazil
Novartis Investigative Site
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Quebec,G1V 4W2,Canada
Novartis Investigative Site
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Toulouse Cedex,31059,France
Novartis Investigative Site
Recruiting
Frankfurt,60590,Germany
Novartis Investigative Site
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Freiburg,79100,Germany
Novartis Investigative Site
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Pecs,7623,Hungary
Novartis Investigative Site
Recruiting
Ramat Gan,52621,Israel
Novartis Investigative Site
Recruiting
Jerusalem,9112001,Israel
Novartis Investigative Site
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Roma,RM,00100,Italy
Novartis Investigative Site
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Milano,MI,20162,Italy
Novartis Investigative Site
Recruiting
Ashrafieh,166830,Lebanon
Novartis Investigative Site
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Rotterdam,Zuid Holland,3015 GD,Netherlands
Novartis Investigative Site
Recruiting
Amsterdam,1105 AZ,Netherlands
Novartis Investigative Site
Recruiting
Oslo,0514,Norway
Novartis Investigative Site
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Moscow,127412,Russian Federation
Novartis Investigative Site
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Kemerovo,650002,Russian Federation
Novartis Investigative Site
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Ljubljana,1000,Slovenia
Novartis Investigative Site
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Cape Town,Western Cape,7130,South Africa
Novartis Investigative Site
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Bloemfontein,Free State,9301,South Africa
Novartis Investigative Site
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A Coruna,15001,Spain
Novartis Investigative Site
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Oviedo,Asturias,33011,Spain
Novartis Investigative Site
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Pamplona,Navarra,31008,Spain
Novartis Investigative Site
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Geneve 14,1211,Switzerland
Novartis Investigative Site
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Taipei,103616,Taiwan
Novartis Investigative Site
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Istanbul,TUR,34098,Turkey
Novartis Investigative Site
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Izmir,35040,Turkey
Novartis Investigative Site
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Middlesex,UB9 6JH,United Kingdom
Novartis Investigative Site
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Boca Raton,Florida,33434,United States
Novartis Investigative Site
Recruiting
New York,New York,10029,United States
Worldwide Contacts
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