Study to Evaluate Efficacy and Safety of Inclisiran in Children With Heterozygous Familial Hypercholesterolemia
Start Date
12/9/2024
Completion Date
4/15/2029
Summary
This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in children (aged 6 to \<12 years) with heterozygous familial hypercholesterolemia (HeFH) and elevated low density lipoprotein cholesterol (LDLC).
Detailed Description
This is a two-part (1 year double-blind inclisiran versus placebo / 1 year open-label inclisiran) multicenter study designed to evaluate safety, tolerability, and efficacy of inclisiran in children (aged 6 to \<12 years) with heterozygous familial hypercholesterolemia (HeFH) and elevated low density lipoprotein cholesterol (LDL-C) on stable standard of care background lipid-lowering therapy.
Eligibility Criteria
Age Range: 6 years to 11 years
Interventions
Inclisiran
Placebo
Conditions
Locations
UC San Francisco Medical Center
San Francisco, California 94143-0348
United States
UC San Francisco Medical Center
San Francisco, California 94143
United States
Children's National Hospital
Washington D.C., District of Columbia 20010
United States
Childrens National Hospital
Washington D.C., District of Columbia 20010
United States
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
Primary Childrens Medical Center
Salt Lake City, Utah 84113
United States
Primary Childrens Medical Center
Salt Lake City, Utah 84113
United States
Virginia Commonwealth University
Richmond, Virginia 23298
United States
West Virginia Childrens Hospital
Morgantown, West Virginia 26506
United States
West Virginia Childrens Hospital
Morgantown, West Virginia 26506
United States
Novartis Investigative Site
Buenos Aires, C1245AAM
Argentina
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CABA, C1181ACH
Argentina
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Salzburg, 5020
Austria
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Vienna, 1090
Austria
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Brussels, 1200
Belgium
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Leuven, 3000
Belgium
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Fortaleza, Ceará 60430-275
Brazil
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Rio de Janeiro, Rio de Janeiro 20211-340
Brazil
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Porto Alegre, Rio Grande do Sul 90020-020
Brazil
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São Paulo, São Paulo 05403 000
Brazil
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Beijing, Beijing Municipality 100013
China
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Shanghai, 200127
China
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Prague, 128 08
Czechia
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Prague, 150 06
Czechia
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Marseille, 13885
France
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Nantes, 44093
France
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Paris, 75012
France
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Freiburg im Breisgau, Baden-Wurttemberg 79106
Germany
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Frankfurt am Main, Hesse 60590
Germany
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Hanover, 30173
Germany
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Athens, 115 27
Greece
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Ioannina, 455 00
Greece
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Hong Kong, 999077
Hong Kong
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Budapest, 1026
Hungary
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Jerusalem, 9112001
Israel
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Ramat Gan, 5265601
Israel
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Milan, MI 20162
Italy
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Roma, RM 00165
Italy
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Torino, TO 10126
Italy
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Verona, VR 37126
Italy
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Kuala Lumpur, Kuala Lumpur 50586
Malaysia
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Amsterdam, North Holland 1105 AZ
Netherlands
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Bialystok, 15-274
Poland
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Gdansk, 80 952
Poland
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Lodz, Łódź Voivodeship 93-338
Poland
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Coimbra, 3000-602
Portugal
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Lisbon, 1649-035
Portugal
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Porto, 4050-651
Portugal
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Porto, 4200 319
Portugal
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Bloemfontein, Free State 9301
South Africa
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Elche, Alicante 03203
Spain
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Cadiz, Andalusia 11009
Spain
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Badalona, Barcelona 08916
Spain
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Esplugues, Barcelona 08950
Spain
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Pamplona, Navarre 31008
Spain
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Barcelona, 08041
Spain
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Málaga, 29011
Spain
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Seville, 41013
Spain
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Taipei, 111045
Taiwan
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Taipei, 11217
Taiwan
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Adana, Saricam 01330
Turkey (Türkiye)
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Ankara, Yenimahalle 06500
Turkey (Türkiye)
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Izmir, 35100
Turkey (Türkiye)
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West Midlands, Birmingham B4 6NH
United Kingdom
Novartis Investigative Site
London, NW3 2QG
United Kingdom