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
Sao Paulo,SP,04023-900,Brazil
Novartis Investigative Site
Recruiting
Sao Paulo,SP,05403 000,Brazil
Novartis Investigative Site
Recruiting
Fortaleza,Ceara,60430275,Brazil
Novartis Investigative Site
Recruiting
Praha 5,150 06,Czechia
Novartis Investigative Site
Recruiting
Praha,12808,Czechia
Novartis Investigative Site
Recruiting
Jerusalem,9112001,Israel
Novartis Investigative Site
Recruiting
Ramat Gan,52621,Israel
Novartis Investigative Site
Recruiting
Irbid,22110,Jordan
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Recruiting
Ashrafieh,166830,Lebanon
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Recruiting
Rotterdam,Zuid Holland,3015 gd,Netherlands
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Recruiting
Amsterdam,1105 az,Netherlands
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Recruiting
Oslo,0514,Norway
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Recruiting
Poprad,058 01,Slovakia
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Ljubljana,1000,Slovenia
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Recruiting
Bloemfontein,Free State,9301,South Africa
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Recruiting
Cape Town,Western Cape,7130,South Africa
Novartis Investigative Site
Recruiting
A Coruna,15001,Spain
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Cordoba,Andalucia,14004,Spain
Novartis Investigative Site
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Oviedo,Asturias,33011,Spain
Novartis Investigative Site
Recruiting
Geneve 14,1211,Switzerland
Novartis Investigative Site
Recruiting
Adana,01330,Turkey
Novartis Investigative Site
Recruiting
Ankara,06500,Turkey
Childrens Hosp Pittsburgh UPMC
Recruiting
Pittsburgh,Pennsylvania,15224,United States
Brenda Mendizabal
Excel Medical Clinical Trials LLC
Recruiting
Boca Raton,Florida,33434,United States
Seth J Baum
Cincinnati Childrens Hospital MC
Recruiting
Cincinnati,Ohio,45229-3039,United States
Amy Shah
Worldwide Contacts
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