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
Novartis Investigative Site
Recruiting
Fortaleza,Ceara,60430275,Brazil
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Sao Paulo,SP,04023-900,Brazil
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Sao Paulo,SP,05403 000,Brazil
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Toulouse Cedex,31059,France
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Athens,115 27,Greece
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Jerusalem,9112001,Israel
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Ramat Gan,52621,Israel
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Modena,MO,41124,Italy
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Roma,RM,00165,Italy
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Ashrafieh,166830,Lebanon
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Rotterdam,Zuid Holland,3015 gd,Netherlands
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Amsterdam,1105 az,Netherlands
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Oslo,0514,Norway
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Gdansk,80 952,Poland
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Ljubljana,1000,Slovenia
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Bloemfontein,Free State,9301,South Africa
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Cape Town,Western Cape,7130,South Africa
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Oviedo,Asturias,33011,Spain
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Pamplona,Navarra,31008,Spain
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A Coruna,15001,Spain
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Cordoba,Andalucia,14004,Spain
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Geneve 14,1211,Switzerland
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Adana,01330,Turkey
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Ankara,06500,Turkey
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Middlesex,Ub9 6jh,United Kingdom
Cincinnati Childrens Hospital MC .
Recruiting
Cincinnati,Ohio,45229-3039,United States
Amy Shah
Excel Medical Clinical Trials LLC
Recruiting
Boca Raton,Florida,33434,United States
Seth J Baum
Worldwide Contacts
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