ACTIVE_NOT_RECRUITING

Long-term Safety and Tolerability of Inclisiran in Participants With HeFH or HoFH Who Have Completed the Adolescent ORION-16 or ORION-13 Studies

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 or ORION-13 studies.

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 Adolescent ORION-16 or ORION-13 Studies (VICTORION-PEDS-OLE)

Quick Facts

Study Start:2023-02-10
Study Completion:2028-03-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05682378

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Novartis Pharmaceuticals
STUDY_DIRECTOR
Novartis Pharmaceuticals

Study Locations (Sites)

Excel Medical Clinical Trials LLC
Boca Raton, Florida, 33434
United States
Icahn School of Med at Mt Sinai
New York, New York, 10029
United States
Cincinnati Childrens Hospital MC
Cincinnati, Ohio, 45229-3039
United States
Childrens Hosp Pittsburgh UPMC
Pittsburgh, Pennsylvania, 15224
United States
Primary Childrens Medical Center
Salt Lake, Utah, 84113
United States

Collaborators and Investigators

Sponsor: Novartis Pharmaceuticals

  • Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-10
Study Completion Date2028-03-02

Study Record Updates

Study Start Date2023-02-10
Study Completion Date2028-03-02

Terms related to this study

Keywords Provided by Researchers

  • KJX839
  • heterozygous familial hypercholesterolemia
  • homozygous familial hypercholesterolemia
  • familial hypercholesterolemia
  • FH
  • inclisiran
  • pediatric

Additional Relevant MeSH Terms

  • Heterozygous or Homozygous Familial Hypercholesterolemia