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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

RecruitingPhase 3Ages 2 Years - 100 YearsAllNovartis Pharmaceuticals
NCT05682378 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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 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
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What it tests

  • Inclisiran
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Where

52 sites
Excel Medical Clinical Trials LLC
Boca Raton, United States
Icahn School of Med at Mt Sinai
New York, United States
Cincinnati Childrens Hospital MC
Cincinnati, United States
Childrens Hosp Pittsburgh UPMC
Pittsburgh, United States
Primary Childrens Medical Center
Salt Lake City, United States
Novartis Investigative Site
Formosa, Argentina
Novartis Investigative Site
Fortaleza, Brazil
Novartis Investigative Site
São Paulo, Brazil

…and 44 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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