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

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.

Conditions

Heterozygous or Homozygous Familial Hypercholesterolemia

Study Overview

Study Details

Study 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 or ORION-13 studies.

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)

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

Condition
Heterozygous or Homozygous Familial Hypercholesterolemia
Intervention / Treatment

-

Contacts and Locations

Boca Raton

Excel Medical Clinical Trials LLC, Boca Raton, Florida, United States, 33434

New York

Icahn School of Med at Mt Sinai ., New York, New York, United States, 10029

Cincinnati

Cincinnati Childrens Hospital MC ., Cincinnati, Ohio, United States, 45229-3039

Salt Lake City

Primary Childrens Medical Center Research, Salt Lake City, Utah, United States, 84113

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    12 Years to

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    Novartis Pharmaceuticals,

    Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

    Study Record Dates

    2028-06-30