Long-term Safety and Tolerability of Inclisiran in Participants With HeFH or HoFH Who Have Completed the Pediatric ORION-16, ORION-13, ORION-20, or ORION-19 Studies

Conditions

• Heterozygous or Homozygous Familial Hypercholesterolemia

Eligibility Criteria

Sex

ALL

Age

12 Years - 100 Years

Healthy Volunteers

Not accepted

Interventions

• Inclisiran — DRUG
  Solution for injection

Study Details

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 (CKJX839C12301), ORION-13 (CKJX839C12302), ORION-20 (CKJX839C12303) or ORION-19 (CKJX839C12304) studies.

Key Dates

Start date

Feb 10, 2023

Status verified

May 2026

Primary completion

Mar 25, 2032

Completion

Mar 28, 2032

Study Design

Enrollment

195 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Inclisiran
  Participants who have completed ORION-16 or ORION-13 receive inclisiran sodium 300mg (equivalent to 284mg inclisiran\*) in 1.5mL solution. Participants who have completed ORION-19 and ORION-20 receive Inclisiran dose levels based on weight.

Primary Outcome Measure

Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) [ Time Frame: From Day 1 in the study up to the end of study visit; up to 1080 days ]

Central Contacts

• Novartis Pharmaceuticals
  1-888-669-6682
  [email protected]
• Novartis Pharmaceuticals
  +41613241111

Locations (5)

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