Long-term Safety and Tolerability of Inclisiran in Participants With HeFH or HoFH Who Have Completed the Adolescent ORION-16 or ORION-13 Studies
NCT ID: NCT05682378
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
131 participants
INTERVENTIONAL
2023-02-10
2028-03-02
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Inclisiran
Inclisiran sodium 300mg (equivalent to 284mg inclisiran\*) in 1.5mL solution
Inclisiran
Inclisiran sodium 300mg (equivalent to 284mg inclisiran\*) in 1.5mL solution administered subcutaneously in pre-filled syringe
Interventions
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Inclisiran
Inclisiran sodium 300mg (equivalent to 284mg inclisiran\*) in 1.5mL solution administered subcutaneously in pre-filled syringe
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Per investigator's clinical judgment, participant derived benefit from treatment with inclisiran in the ORION-16 or ORION-13 studies
Key exclusion:
* 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 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
12 Years
100 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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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
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Formosa, Formosa Province, Argentina
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Fortaleza, Ceará, Brazil
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São Paulo, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Québec, Quebec, Canada
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Prague, , Czechia
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Prague, , Czechia
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Besançon, , France
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Toulouse, , France
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Frankfurt am Main, Hesse, Germany
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Freiburg im Breisgau, , Germany
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Athens, , Greece
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Athens, , Greece
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Pécs, Baranya, Hungary
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Jerusalem, , Israel
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Ramat Gan, , Israel
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Milan, MI, Italy
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Modena, MO, Italy
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Roma, RM, Italy
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Roma, RM, Italy
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Irbid, , Jordan
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Beirut, , Lebanon
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Beirut, , Lebanon
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Sungai Buloh, Selangor, Malaysia
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Kuala Lumpur, , Malaysia
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Amsterdam, North Holland, Netherlands
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Rotterdam, South Holland, Netherlands
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Oslo, , Norway
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Gdansk, , Poland
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Lodz, Łódź Voivodeship, Poland
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Kemerovo, , Russia
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Moscow, , Russia
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Poprad, , Slovakia
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Ljubljana, , Slovenia
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Bloemfontein, Free State, South Africa
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Cape Town, Western Cape, South Africa
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Pamplona, Navarre, Spain
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Oviedo, Principality of Asturias, Spain
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A Coruña, , Spain
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Córdoba, , Spain
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Geneva, , Switzerland
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Taipei, , Taiwan
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Istanbul, Fatih, Turkey (Türkiye)
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Adana, Saricam, Turkey (Türkiye)
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Ankara, Yenimahalle, Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Middlesex, , United Kingdom
Countries
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Other Identifiers
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2022-002316-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CKJX839C12001B
Identifier Type: -
Identifier Source: org_study_id