drugset / Trial / NCT05682378

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

NCT05682378

Phase 3 Recruiting 195 enrolled Novartis Pharmaceuticals
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2023-02-10
Primary completion
2032-03-25
Completion
2032-03-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Inclisiran Small interfering RNA (siRNA) 300 mg