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
Recruiting · NCT05682378 · Interventional (participants receive a specific treatment) · Lead sponsor: Novartis Pharmaceuticals
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
12 Years to 100 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Eligibility criteria (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
Where it is running
52 locations listed across 5 US states.
- 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 - A Coruña, Spain
- Novartis Investigative Site - Athens, Greece
- Novartis Investigative Site - Athens, Greece
- Novartis Investigative Site - Beirut, Lebanon
- Novartis Investigative Site - Beirut, Lebanon
- Novartis Investigative Site - Besançon, France
- Novartis Investigative Site - Córdoba, Spain
- Novartis Investigative Site - Freiburg im Breisgau, Germany
- Novartis Investigative Site - Gdansk, Poland
- Novartis Investigative Site - Geneva, Switzerland
- Novartis Investigative Site - Irbid, Jordan
- Novartis Investigative Site - Izmir, Turkey (Türkiye)
- Novartis Investigative Site - Jerusalem, Israel
- Novartis Investigative Site - Kemerovo, Russia
- Novartis Investigative Site - Kuala Lumpur, Malaysia
- Novartis Investigative Site - Ljubljana, Slovenia
- Novartis Investigative Site - Middlesex, United Kingdom
- Novartis Investigative Site - Moscow, Russia
- Novartis Investigative Site - Oslo, Norway
- Novartis Investigative Site - Poprad, Slovakia
- Novartis Investigative Site - Prague, Czechia
- Novartis Investigative Site - Prague, Czechia
- Novartis Investigative Site - Ramat Gan, Israel
- Novartis Investigative Site - Taipei, Taiwan
- Novartis Investigative Site - Toulouse, France
- Novartis Investigative Site - Pécs, Baranya, Hungary
- Novartis Investigative Site - Fortaleza, Ceará, Brazil
- Novartis Investigative Site - Istanbul, Fatih, Turkey (Türkiye)
- Novartis Investigative Site - Formosa, Formosa Province, Argentina
- Novartis Investigative Site - Bloemfontein, Free State, South Africa
- Novartis Investigative Site - Frankfurt am Main, Hesse, Germany
- Novartis Investigative Site - Milan, MI, Italy
- Novartis Investigative Site - Modena, MO, Italy
- Novartis Investigative Site - Pamplona, Navarre, Spain
- Novartis Investigative Site - Amsterdam, North Holland, Netherlands
- Novartis Investigative Site - Oviedo, Principality of Asturias, Spain
- Novartis Investigative Site - Québec, Quebec, Canada
- Novartis Investigative Site - Roma, RM, Italy
- Novartis Investigative Site - Roma, RM, Italy
- Novartis Investigative Site - Adana, Saricam, Turkey (Türkiye)
- Novartis Investigative Site - Sungai Buloh, Selangor, Malaysia
- Novartis Investigative Site - Rotterdam, South Holland, Netherlands
- Novartis Investigative Site - São Paulo, São Paulo, Brazil
- Novartis Investigative Site - São Paulo, São Paulo, Brazil
- Novartis Investigative Site - Cape Town, Western Cape, South Africa
- Novartis Investigative Site - Ankara, Yenimahalle, Turkey (Türkiye)
- Novartis Investigative Site - Lodz, Łódź Voivodeship, Poland