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)

Phase 3

Recruiting

Conditions: elevated LDL-C cholesterol
familial hypercholesteriolemia
10007510

Registration Number: NL-OMON53697

Lead Sponsor: ovartis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 23

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

Exclusion Criteria

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of the study is to evaluate the long-term safety and<br /><br>tolerability of inclisiran in participants with HeFH or HoFH<br /><br>(Treatment-emergent (serious) adverse events, vital signs, growth, laboratory<br /><br>parameters) </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To evaluate the long-term effect of inclisiran treatment on low-density<br /><br>lipoprotein cholesterol (LDL-C) levels (change in LDL-C from baseline in the<br /><br>feeder study to end of study (EoS))</p><br>