*Long-term safety and tolerability of inclisiran in participants with HeFH or HoFH who have completed ORION-16 or ORION-13 studies (VICTORION-PEDS-OLE)
Research type
Research Study
Full 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)
IRAS ID
1007316
Contact name
Clement Dubos
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2022-002316-23
Research summary
The current study is designed to find out if inclisiran (also referred to as KJX839 or Leqvio®) is a safe treatment if taken over an extended period of time in a population of adolescents and young adults with a certain genetic disease that causes high cholesterol levels (called familial hypercholesterolemia, FH). There are two types of this genetic disease, both of which will be included in the current study (so-called heterozygous FH, and the more severe homozygous FH). The study is an extension to two preceding studies in adolescents that are already running (called ORION-16 and ORION-13 studies) and will provide these participants continued access to inclisiran. Participants who completed one of the two preceding studies and fulfil all entry criteria for the current study will directly start with the current study, meaning the last day of the preceding study is at the same time the first day of the current study. All participants will receive inclisiran treatment, the maximum duration each participant will stay in the study is 3 years.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
23/NW/0108
Date of REC Opinion
15 Sep 2023
REC opinion
Further Information Favourable Opinion