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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
131
Inclisiran sodium 300mg (equivalent to 284mg inclisiran\*) in 1.5mL solution administered subcutaneously in pre-filled syringe
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs)
Safety and tolerability: TEAEs, TESAEs (incidence, severity, relationship to study drug and discontinuation due to TEAEs)
Time frame: From Day 1 in the study up to the end of study visit; up to 1080 days
Percentage and absolute change in LDL-C from baseline in the feeder study to end of study
Evaluate the long-term effect of inclisiran (from baseline of feeder study to end of study) in lowering LDL-C
Time frame: Baseline (of feeder study) and Day 1080
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Excel Medical Clinical Trials LLC
Boca Raton, Florida, United States
Icahn School of Med at Mt Sinai
New York, New York, United States
Cincinnati Childrens Hospital MC
Cincinnati, Ohio, United States
Childrens Hosp Pittsburgh UPMC
Pittsburgh, Pennsylvania, United States
Primary Childrens Medical Center
Salt Lake City, Utah, United States
Novartis Investigative Site
Formosa, Formosa Province, Argentina
Novartis Investigative Site
Fortaleza, Ceará, Brazil
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Novartis Investigative Site
Québec, Quebec, Canada
...and 42 more locations