Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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
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

NCT05682378

RecruitingPhase 3

Sponsor: Novartis Pharmaceuticals

Conditions: Heterozygous or Homozygous Familial Hypercholesterolemia

Interventions: Inclisiran

Countries: United States, Argentina, Brazil, Canada, Czechia, France, Germany, Greece

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.

Eligibility overview

Sex: ALL

Age: 12 Years to 100 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (52)
  • Boca Raton, Florida, United States
  • New York, New York, United States
  • Cincinnati, Ohio, United States
  • Pittsburgh, Pennsylvania, United States
  • Salt Lake City, Utah, United States
  • Formosa, Formosa Province, Argentina
  • Fortaleza, Ceará, Brazil
  • São Paulo, São Paulo, Brazil
  • São Paulo, São Paulo, Brazil
  • Québec, Quebec, Canada
  • Prague, Czechia
  • Prague, Czechia
  • Besançon, France
  • Toulouse, France
  • Frankfurt am Main, Hesse, Germany
  • Freiburg im Breisgau, Germany
  • Athens, Greece
  • Athens, Greece
  • Pécs, Baranya, Hungary
  • Jerusalem, Israel
  • Ramat Gan, Israel
  • Milan, MI, Italy
  • Modena, MO, Italy
  • Roma, RM, Italy
  • Roma, RM, Italy
  • Irbid, Jordan
  • Beirut, Lebanon
  • Beirut, Lebanon
  • Sungai Buloh, Selangor, Malaysia
  • Kuala Lumpur, Malaysia
  • + 22 more on CT.gov