Trial intelligence / Profile preview

Long-term safety extension of inclisiran in pediatric familial hypercholesterolemia

NL-OMON59036Phase 3Active, not recruiting

Sponsor
Novartis
Start
Apr 2023
Modality
Chemically Modified siRNA → Small Interfering RNA (siRNA) → Small RNA Therapeutics → RNA Therapeutics → Nucleic Acid Therapeutics, Conjugated siRNA → Small Interfering RNA (siRNA) → Small RNA Therapeutics → RNA Therapeutics → Nucleic Acid Therapeutics, MicroRNA (miRNA) → Small RNA Therapeutics → RNA Therapeutics → Nucleic Acid Therapeutics
Countries
1
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Overview

Phase 3, open-label, single-arm trial of inclisiran in familial hypercholesterolemia (FH), heterozygous familial hypercholesterolemia (HeFH) and homozygous familial hypercholesterolemia (HoFH), sponsored by Novartis. Primary endpoints: Treatment-emergent adverse events and serious adverse events, Vital signs and 2 more. Started Apr 2023; status: active, not recruiting.

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Drugs

inclisiran
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Conditions

familial hypercholesterolemia (FH)heterozygous familial hypercholesterolemia (HeFH)homozygous familial hypercholesterolemia (HoFH)

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