Long-term Safety and Tolerability of Inclisiran in Participants With HeFH or HoFH Who Have Completed the Pediatric ORION-16, ORION-13, ORION-20, or ORION-19 Studies
Start Date
2/10/2023
Completion Date
3/28/2032
Summary
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 (CKJX839C12301), ORION-13 (CKJX839C12302), ORION-20 (CKJX839C12303) or ORION-19 (CKJX839C12304) studies.
Detailed Description
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.
Eligibility Criteria
Age Range: 12 years to 100 years
Interventions
Inclisiran
Conditions
Locations
Excel Medical Clinical Trials LLC
Boca Raton, Florida 33434
United States
Icahn School of Med at Mt Sinai
New York, New York 10029
United States
Cincinnati Childrens Hospital MC
Cincinnati, Ohio 45229-3039
United States
Childrens Hosp Pittsburgh UPMC
Pittsburgh, Pennsylvania 15224
United States
Primary Childrens Medical Center
Salt Lake City, Utah 84113
United States
Novartis Investigative Site
Formosa, Formosa Province P3600
Argentina
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Fortaleza, Ceará 60430-275
Brazil
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São Paulo, São Paulo 04023-900
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São Paulo, São Paulo 05403 000
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Québec, Quebec G1V 4W2
Canada
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Prague, 128 08
Czechia
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Prague, 150 06
Czechia
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Besançon, 25030
France
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Toulouse, 31059
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Frankfurt am Main, Hesse 60590
Germany
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Freiburg im Breisgau, 79100
Germany
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Athens, 115 27
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Athens, 185 47
Greece
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Pécs, Baranya 7623
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Jerusalem, 9112001
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Ramat Gan, 5265601
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Milan, MI 20162
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Modena, MO 41124
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Roma, RM 00161
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Roma, RM 00165
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Irbid, 22110
Jordan
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Beirut, 113-0236
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Beirut, 166830
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Sungai Buloh, Selangor 47000
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Kuala Lumpur, 59100
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Amsterdam, North Holland 1105 AZ
Netherlands
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Rotterdam, South Holland 3015 GD
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Oslo, 0514
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Gdansk, 80 952
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Lodz, Łódź Voivodeship 93-338
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Kemerovo, 650002
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Moscow, 127412
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Poprad, 058 01
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Ljubljana, 1000
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Bloemfontein, Free State 9301
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Cape Town, Western Cape 7130
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Pamplona, Navarre 31008
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Oviedo, Principality of Asturias 33011
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A Coruña, 15001
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Taipei, 111045
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Istanbul, Fatih 34098
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Adana, Saricam 01330
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Ankara, Yenimahalle 06500
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Izmir, 35100
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Middlesex, UB9 6JH
United Kingdom