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)
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 (CKJX839C12301), ORION-13 (CKJX839C12302), ORION-20 (CKJX839C12303) or ORION-19 (CKJX839C12304) studies.
Description
This is an open-label, single arm, multicenter study designed to evaluate long-term safety and tolerability of inclisiran. In addition, the study will provide participants the opportunity to have continued access to treatment with inclisiran.
Eligibility
- Age range
- 12–100 years
- Sex
- All
- Healthy volunteers
- No
Key inclusion: * 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 Key exclusion: * Participants who in the feeder ORION-16, ORION-13, ORION-20, or ORION-19 studies either screen failed or permanently discontinued from the treatment/study for any reason or had serious safety or tolerability issues related to inclisiran treatment * Any uncontrolled or serious di…
Interventions
- DrugInclisiran
Solution for injection
Locations (52)
- Excel Medical Clinical Trials LLCBoca Raton, Florida
- Icahn School of Med at Mt SinaiNew York, New York
- Cincinnati Childrens Hospital MCCincinnati, Ohio
- Childrens Hosp Pittsburgh UPMCPittsburgh, Pennsylvania
- Primary Childrens Medical CenterSalt Lake City, Utah
- Novartis Investigative SiteFormosa, Formosa Province