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)
Status: Active_not_recruiting
Location: See all (50) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 100
Healthy Volunteers: f
View:
• 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
Locations
United States
Florida
Excel Medical Clinical Trials LLC
Boca Raton
New York
Icahn School of Med at Mt Sinai
New York
Ohio
Cincinnati Childrens Hospital MC
Cincinnati
Pennsylvania
Childrens Hosp Pittsburgh UPMC
Pittsburgh
Utah
Primary Childrens Medical Center
Salt Lake City
Other Locations
Argentina
Novartis Investigative Site
Formosa
Brazil
Novartis Investigative Site
Fortaleza
Novartis Investigative Site
São Paulo
Novartis Investigative Site
São Paulo
Canada
Novartis Investigative Site
Québec
France
Novartis Investigative Site
Besançon
Novartis Investigative Site
Toulouse
Germany
Novartis Investigative Site
Frankfurt Am Main
Novartis Investigative Site
Freiburg Im Breisgau
Greece
Novartis Investigative Site
Athens
Novartis Investigative Site
Athens
Hungary
Novartis Investigative Site
Pécs
Israel
Novartis Investigative Site
Jerusalem
Novartis Investigative Site
Ramat Gan
Italy
Novartis Investigative Site
Milan
Novartis Investigative Site
Modena
Novartis Investigative Site
Roma
Novartis Investigative Site
Roma
Jordan
Novartis Investigative Site
Irbid
Lebanon
Novartis Investigative Site
Beirut
Novartis Investigative Site
Beirut
Malaysia
Novartis Investigative Site
Kuala Lumpur
Novartis Investigative Site
Sungai Buloh
Netherlands
Novartis Investigative Site
Amsterdam
Novartis Investigative Site
Rotterdam
Norway
Novartis Investigative Site
Oslo
Poland
Novartis Investigative Site
Gdansk
Novartis Investigative Site
Lodz
Russian Federation
Novartis Investigative Site
Kemerovo
Novartis Investigative Site
Moscow
Slovakia
Novartis Investigative Site
Poprad
Slovenia
Novartis Investigative Site
Ljubljana
South Africa
Novartis Investigative Site
Bloemfontein
Novartis Investigative Site
Cape Town
Spain
Novartis Investigative Site
A Coruña
Novartis Investigative Site
Córdoba
Novartis Investigative Site
Oviedo
Novartis Investigative Site
Pamplona
Switzerland
Novartis Investigative Site
Geneva
Taiwan
Novartis Investigative Site
Taipei
Turkey
Novartis Investigative Site
Adana
Novartis Investigative Site
Ankara
Novartis Investigative Site
Istanbul
Novartis Investigative Site
Izmir
United Kingdom
Novartis Investigative Site
Middlesex
Time Frame
Start Date: 2023-02-10
Completion Date: 2028-03-02
Participants
Target number of participants: 131
Treatments
Experimental: Inclisiran
Inclisiran sodium 300mg (equivalent to 284mg inclisiran\*) in 1.5mL solution
Related Therapeutic Areas
Sponsors
Leads: Novartis Pharmaceuticals