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Recruiting NCT05682378

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

Phase III Interventional Heterozygous or Homozygous Familial Hypercholesterolemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Inclisiran.
Who it may be relevant to
Registry conditions: Heterozygous or Homozygous Familial Hypercholesterolemia. Basic parameters: 12 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Argentina, Brazil, Canada, Czechia +21
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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 Pediatric ORION-16, ORION-13, ORION-20 or ORION-19 Studies (VICTORION-PEDS-OLE)

Overview

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.

Detailed description

This is an open-label, single arm, multicenter study designed to evaluate long-term safety and tolerability of inclisiran. In addition, the study will provide participants the opportunity to have continued access to treatment with inclisiran.

Interventions

  • Drug Inclisiran
    Solution for injection

Primary outcome measures

  • Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) [Time frame: From Day 1 in the study up to the end of study visit; up to 1080 days]
Secondary outcome measures (1)
  • Percentage and absolute change in LDL-C from baseline in the feeder study to end of study [Time frame: Baseline (of feeder study) and Day 1080]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 5 centers
  • Excel Medical Clinical Trials LLC — Boca Raton
  • Icahn School of Med at Mt Sinai — New York
  • Cincinnati Childrens Hospital MC — Cincinnati
  • Childrens Hosp Pittsburgh UPMC — Pittsburgh
  • Primary Childrens Medical Center — Salt Lake City
Italy · 4 centers
  • Novartis Investigative Site — Milan
  • Novartis Investigative Site — Modena
  • Novartis Investigative Site — Roma
  • Novartis Investigative Site — Roma
Spain · 4 centers
  • Novartis Investigative Site — Pamplona
  • Novartis Investigative Site — Oviedo
  • Novartis Investigative Site — A Coruña
  • Novartis Investigative Site — Córdoba
Turkey (Türkiye) · 4 centers
  • Novartis Investigative Site — Istanbul
  • Novartis Investigative Site — Adana
  • Novartis Investigative Site — Ankara
  • Novartis Investigative Site — Izmir
Brazil · 3 centers
  • Novartis Investigative Site — Fortaleza
  • Novartis Investigative Site — São Paulo
  • Novartis Investigative Site — São Paulo
Czechia · 2 centers
  • Novartis Investigative Site — Prague
  • Novartis Investigative Site — Prague
France · 2 centers
  • Novartis Investigative Site — Besançon
  • Novartis Investigative Site — Toulouse
Germany · 2 centers
  • Novartis Investigative Site — Frankfurt am Main
  • Novartis Investigative Site — Freiburg im Breisgau
Greece · 2 centers
  • Novartis Investigative Site — Athens
  • Novartis Investigative Site — Athens
Israel · 2 centers
  • Novartis Investigative Site — Jerusalem
  • Novartis Investigative Site — Ramat Gan
Lebanon · 2 centers
  • Novartis Investigative Site — Beirut
  • Novartis Investigative Site — Beirut
Malaysia · 2 centers
  • Novartis Investigative Site — Sungai Buloh
  • Novartis Investigative Site — Kuala Lumpur
Netherlands · 2 centers
  • Novartis Investigative Site — Amsterdam
  • Novartis Investigative Site — Rotterdam
Poland · 2 centers
  • Novartis Investigative Site — Gdansk
  • Novartis Investigative Site — Lodz
Russia · 2 centers
  • Novartis Investigative Site — Kemerovo
  • Novartis Investigative Site — Moscow
South Africa · 2 centers
  • Novartis Investigative Site — Bloemfontein
  • Novartis Investigative Site — Cape Town
Argentina · 1 center
  • Novartis Investigative Site — Formosa
Canada · 1 center
  • Novartis Investigative Site — Québec
Hungary · 1 center
  • Novartis Investigative Site — Pécs
Jordan · 1 center
  • Novartis Investigative Site — Irbid
Norway · 1 center
  • Novartis Investigative Site — Oslo
Slovakia · 1 center
  • Novartis Investigative Site — Poprad
Slovenia · 1 center
  • Novartis Investigative Site — Ljubljana
Switzerland · 1 center
  • Novartis Investigative Site — Geneva
Taiwan · 1 center
  • Novartis Investigative Site — Taipei
United Kingdom · 1 center
  • Novartis Investigative Site — Middlesex

Identifiers

NCT: NCT05682378 · CKJX839C12001B · 2022-002316-23

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗