ong-term safety and tolerability of inclisiran in participants with heterozygous familial hypercholesterolaemia or homozygous familial hypercholesterolaemia who have completed the adolescent ORION-16 or ORION-13 studies

Phase 1

• Conditions: MedDRA version: 20.0Level: LLTClassification code 10049593Term: Familial hypercholesterolaemiaSystem Organ Class: 100000004850; Familial Hypercholesterolemia; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2022-002316-23-NO
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-10-25
• Last Update Posted: 26 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

• Male and female participants with a diagnosis of HeFH or HoFH who completed the ORION-16 or ORION-13 studies, meaning the participant received the last dose of study drug and completed the final study visit as per applicable protocol
• Per investigator`s clinical judgment, participant derived benefit from treatment with inclisiran in the ORION-16 or ORION-13 studies
• Continuing current lipid-lowering therapies (such as e.g. statin and/or ezetimibe) from the feeder study with no planned medication or dose change during study participation

Are the trial subjects under 18? yes
Number of subjects for this age range: 103
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 62
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Participants who in the preceding 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
• Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified