Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-01-01 @ 3:53 AM
Study NCT ID:
NCT03851705
Status:
COMPLETED
Last Update Posted:
2023-01-30
First Post:
2019-02-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Inclisiran in Participants With Homozygous Familial Hypercholesterolemia (HoFH)
Sponsor:
Novartis Pharmaceuticals
Organization:
Study Overview
Official Title:
A Two-Part (Double-Blind Placebo Controlled/Open-Label) Multicenter Study to Evaluate Safety, Tolerability, and Efficacy of Inclisiran in Subjects With Homozygous Familial Hypercholesterolemia (Hofh) (ORION-5)
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ORION-5
Brief Summary:
This study was a Phase III,A two-part (double-blind placebo-controlled/open-label) multicenter study to evaluate safety, tolerability, and efficacy of inclisiran in subjects with homozygous familial hypercholesterolemia (HoFH).
Detailed Description:
This study had two sequential parts:
* Part 1: 6-month double-blind period in which subjects were randomized to receive either inclisiran or placebo
* Part 2: 18-month open-label follow-up period; placebo-treated subjects from Part 1 were transitioned to inclisiran at Day 180 and all subjects who participated in an open-label follow-up period of inclisiran only
* Part 1: 6-month double-blind period in which subjects were randomized to receive either inclisiran or placebo
* Part 2: 18-month open-label follow-up period; placebo-treated subjects from Part 1 were transitioned to inclisiran at Day 180 and all subjects who participated in an open-label follow-up period of inclisiran only
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: