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

Novartis

Status and phase

Active, not recruiting

Phase 3

Conditions

Heterozygous or Homozygous Familial Hypercholesterolemia

Treatments

Drug: Inclisiran

Study type

Interventional

Funder types

Industry

Identifiers

NCT05682378

CKJX839C12001B

2022-002316-23 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

131 patients

Sex

All

Ages

12 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key inclusion:

Male and female participants with a diagnosis of HeFH or HoFH who completed the ORION-16 or ORION-13 studies
Per investigator's clinical judgment, participant derived benefit from treatment with inclisiran in the ORION-16 or ORION-13 studies

Key exclusion:

Participants who in the feeder inclisiran ORION-16 and ORION-13 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