● Recruiting

Long-term Safety and Tolerability of Inclisiran in Participants With HeFH or HoFH Who Have Completed the Pediatric ORION-16, ORION-13, ORION-20, or ORION-19 Studies

Condition: Heterozygous or Homozygous Familial Hypercholesterolemia · Sponsor: Novartis Pharmaceuticals

PhasePhase 3

Planned participants195

Who can joinAll sexes, 12 Years to 100 Years

Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Novartis Pharmaceuticals · 1-888-669-6682 · novartis.email@novartis.com

Novartis Pharmaceuticals · +41613241111

Always discuss trial participation with your own doctor first.

Locations (52)

Excel Medical Clinical Trials LLC	Boca Raton, Florida, United States	Completed
Icahn School of Med at Mt Sinai	New York, New York, United States	Active Not Recruiting
Cincinnati Childrens Hospital MC	Cincinnati, Ohio, United States	Completed
Childrens Hosp Pittsburgh UPMC	Pittsburgh, Pennsylvania, United States	Active Not Recruiting
Primary Childrens Medical Center	Salt Lake City, Utah, United States	Completed
Novartis Investigative Site	Formosa, Formosa Province, Argentina	Active Not Recruiting
Novartis Investigative Site	Fortaleza, Ceará, Brazil	Active Not Recruiting
Novartis Investigative Site	São Paulo, São Paulo, Brazil	Completed
Novartis Investigative Site	São Paulo, São Paulo, Brazil	Active Not Recruiting
Novartis Investigative Site	Québec, Quebec, Canada	Active Not Recruiting
Novartis Investigative Site	Prague, Czechia	Active Not Recruiting
Novartis Investigative Site	Prague, Czechia	Active Not Recruiting

+ 40 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05682378