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)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-507278-41-00

Acronym

CKJX839C12001B

Enrollment

Registered

2023-11-30

Start date

2023-02-10

Completion date

Unknown

Last updated

2026-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Familial hypercholsterolemia

Brief summary

Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) (incidence, severity, relationship to study drug and discontinuation due to TEAEs); vital signs; growth; laboratory parameters

Detailed description

Percentage change and absolute change in LDL-C from baseline in the feeder study to end of study (EoS)

Interventions

DRUGINCLISIRAN

DRUG-

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) (incidence, severity, relationship to study drug and discontinuation due to TEAEs); vital signs; growth; laboratory parameters	—

Secondary

Measure	Time frame
Percentage change and absolute change in LDL-C from baseline in the feeder study to end of study (EoS)	—

Countries

Czechia, France, Germany, Greece, Hungary, Italy, Netherlands, Norway, Poland, Slovakia, Slovenia, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026