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 Pediatric ORION-16, ORION-13, ORION-20 or ORION-19 Studies (VICTORION-PEDS-OLE)
Status: 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 (CKJX839C12301), ORION-13 (CKJX839C12302), ORION-20 (CKJX839C12303) or ORION-19 (CKJX839C12304) 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, ORION-13, ORION-20 or ORION-19 studies
• Per investigator's clinical judgment, participant derived benefit from treatment with inclisiran in the ORION-16, ORION-13, ORION-20 or ORION-19 studies
Locations
United States
Florida
Excel Medical Clinical Trials LLC
COMPLETED
Boca Raton
New York
Icahn School of Med at Mt Sinai
ACTIVE_NOT_RECRUITING
New York
Ohio
Cincinnati Childrens Hospital MC
COMPLETED
Cincinnati
Pennsylvania
Childrens Hosp Pittsburgh UPMC
ACTIVE_NOT_RECRUITING
Pittsburgh
Utah
Primary Childrens Medical Center
COMPLETED
Salt Lake City
Other Locations
Argentina
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Formosa
Brazil
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Fortaleza
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
São Paulo
Novartis Investigative Site
COMPLETED
São Paulo
Canada
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Québec
France
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Besançon
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Toulouse
Germany
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Frankfurt Am Main
Novartis Investigative Site
COMPLETED
Freiburg Im Breisgau
Greece
Novartis Investigative Site
COMPLETED
Athens
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Athens
Hungary
Novartis Investigative Site
COMPLETED
Pécs
Israel
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Jerusalem
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Ramat Gan
Italy
Novartis Investigative Site
COMPLETED
Milan
Novartis Investigative Site
COMPLETED
Modena
Novartis Investigative Site
COMPLETED
Roma
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Roma
Jordan
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Irbid
Lebanon
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Beirut
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Beirut
Malaysia
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Kuala Lumpur
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Sungai Buloh
Netherlands
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Amsterdam
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Rotterdam
Norway
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Oslo
Poland
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Gdansk
Novartis Investigative Site
COMPLETED
Lodz
Russian Federation
Novartis Investigative Site
COMPLETED
Kemerovo
Novartis Investigative Site
COMPLETED
Moscow
Slovakia
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Poprad
Slovenia
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Ljubljana
South Africa
Novartis Investigative Site
COMPLETED
Bloemfontein
Novartis Investigative Site
COMPLETED
Cape Town
Spain
Novartis Investigative Site
COMPLETED
A Coruña
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Córdoba
Novartis Investigative Site
COMPLETED
Oviedo
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Pamplona
Switzerland
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Geneva
Taiwan
Novartis Investigative Site
RECRUITING
Taipei
Turkey
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Adana
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Ankara
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Istanbul
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Izmir
United Kingdom
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Middlesex
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
+41613241111
Time Frame
Start Date: 2023-02-10
Estimated Completion Date: 2032-03-28
Participants
Target number of participants: 195
Treatments
Experimental: Inclisiran
Participants who have completed ORION-16 or ORION-13 receive inclisiran sodium 300mg (equivalent to 284mg inclisiran\*) in 1.5mL solution.~Participants who have completed ORION-19 and ORION-20 receive Inclisiran dose levels based on weight.
Related Therapeutic Areas
Sponsors
Leads: Novartis Pharmaceuticals