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An open-label, single arm, multicenter extension study to evaluate long-term safety and tolerability of inclisiran in participants with heterozygous or homozygous familial hypercholesterolemia who have completed the adolescent ORION-16 or ORION-13 studies (VICTORION-PEDS-OLE)

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Trial Profile

An open-label, single arm, multicenter extension study to evaluate long-term safety and tolerability of inclisiran in participants with heterozygous or homozygous familial hypercholesterolemia who have completed the adolescent ORION-16 or ORION-13 studies (VICTORION-PEDS-OLE)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 24 Mar 2025

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At a glance

  • Drugs Inclisiran (Primary)
  • Indications Hyperlipoproteinaemia type IIa
  • Focus Adverse reactions; Registrational
  • Acronyms V-PEDS-OLE; VICTORION-PEDS-OLE
  • Sponsors Novartis Pharma A.G.; Novartis Pharmaceuticals

Most Recent Events

  • 19 Mar 2025 Planned End Date changed from 20 Mar 2028 to 2 Mar 2028.
  • 19 Mar 2025 Planned primary completion date changed from 20 Mar 2028 to 2 Mar 2028.
  • 29 Jan 2025 Planned End Date changed from 30 Jun 2028 to 20 Mar 2028.

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