Last updated 2 months ago
Long-term Safety and Tolerability of Inclisiran in Participants With HeFH or HoFH Who Have Completed the Adolescent ORION-16 or ORION-13 Studies
154 patients around the world
Available in Spain, United States, Brazil
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.
Novartis Pharmaceuticals
154Patients around the world
This study is for people with
Hypercholesterolemia
Familial hypercholesterolemia
Requirements for the patient
From 12 Years
All Gender
Medical requirements
- Male and female participants with a diagnosis of HeFH or HoFH who completed the ORION-16 or ORION-13 studiesPer investigator's clinical judgment, participant derived benefit from treatment with inclisiran in the ORION-16 or ORION-13 studies
- Participants who in the feeder inclisiran ORION-16 and ORION-13 studies either screen failed or permanently discontinued from the treatment/study for any reason or had serious safety or tolerability issues related to inclisiran treatmentAny uncontrolled or serious disease, or any medical, physical, or surgical condition, that may either interfere with participation in the clinical study or interpretation of clinical study results, and/or put the participant at significant risk
StudyV-PEDS-OLE
SponsorNovartis Pharmaceuticals
Conditions
Familial hypercholesterolemia
Requirements
From 12 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05682378
