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Long-term Safety and Tolerability of Inclisiran in Participants With HeFH or HoFH Who Have Completed the Adolescent ORION-16 or ORION-13 Studies
Sponsor: Novartis Pharmaceuticals
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 or ORION-13 studies.
Official title: An Open-label, Single Arm, Multicenter Extension Study to Evaluate Long-term Safety and Tolerability of Inclisiran in Participants With Heterozygous or Homozygous Familial Hypercholesterolemia Who Have Completed the Adolescent ORION-16 or ORION-13 Studies (VICTORION-PEDS-OLE)
Key Details
Gender
All
Age Range
12 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
131
Start Date
2023-02-10
Completion Date
2028-03-02
Last Updated
2026-02-09
Healthy Volunteers
No
Interventions
Inclisiran
Inclisiran sodium 300mg (equivalent to 284mg inclisiran\*) in 1.5mL solution administered subcutaneously in pre-filled syringe
Locations (52)
Excel Medical Clinical Trials LLC
Boca Raton, Florida, United States
Icahn School of Med at Mt Sinai
New York, New York, United States
Cincinnati Childrens Hospital MC
Cincinnati, Ohio, United States
Childrens Hosp Pittsburgh UPMC
Pittsburgh, Pennsylvania, United States
Primary Childrens Medical Center
Salt Lake City, Utah, United States
Novartis Investigative Site
Formosa, Formosa Province, Argentina
Novartis Investigative Site
Fortaleza, Ceará, Brazil
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Novartis Investigative Site
Québec, Quebec, Canada
Novartis Investigative Site
Prague, Czechia
Novartis Investigative Site
Prague, Czechia
Novartis Investigative Site
Besançon, France
Novartis Investigative Site
Toulouse, France
Novartis Investigative Site
Frankfurt am Main, Hesse, Germany
Novartis Investigative Site
Freiburg im Breisgau, Germany
Novartis Investigative Site
Athens, Greece
Novartis Investigative Site
Athens, Greece
Novartis Investigative Site
Pécs, Baranya, Hungary
Novartis Investigative Site
Jerusalem, Israel
Novartis Investigative Site
Ramat Gan, Israel
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Modena, MO, Italy
Novartis Investigative Site
Roma, RM, Italy
Novartis Investigative Site
Roma, RM, Italy
Novartis Investigative Site
Irbid, Jordan
Novartis Investigative Site
Beirut, Lebanon
Novartis Investigative Site
Beirut, Lebanon
Novartis Investigative Site
Sungai Buloh, Selangor, Malaysia
Novartis Investigative Site
Kuala Lumpur, Malaysia
Novartis Investigative Site
Amsterdam, North Holland, Netherlands
Novartis Investigative Site
Rotterdam, South Holland, Netherlands
Novartis Investigative Site
Oslo, Norway
Novartis Investigative Site
Gdansk, Poland
Novartis Investigative Site
Lodz, Łódź Voivodeship, Poland
Novartis Investigative Site
Kemerovo, Russia
Novartis Investigative Site
Moscow, Russia
Novartis Investigative Site
Poprad, Slovakia
Novartis Investigative Site
Ljubljana, Slovenia
Novartis Investigative Site
Bloemfontein, Free State, South Africa
Novartis Investigative Site
Cape Town, Western Cape, South Africa
Novartis Investigative Site
Pamplona, Navarre, Spain
Novartis Investigative Site
Oviedo, Principality of Asturias, Spain
Novartis Investigative Site
A Coruña, Spain
Novartis Investigative Site
Córdoba, Spain
Novartis Investigative Site
Geneva, Switzerland
Novartis Investigative Site
Taipei, Taiwan
Novartis Investigative Site
Istanbul, Fatih, Turkey (Türkiye)
Novartis Investigative Site
Adana, Saricam, Turkey (Türkiye)
Novartis Investigative Site
Ankara, Yenimahalle, Turkey (Türkiye)
Novartis Investigative Site
Izmir, Turkey (Türkiye)
Novartis Investigative Site
Middlesex, United Kingdom