Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06597006
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-11
Brief Title:
Study to Evaluate Safety Tolerability and Efficacy of Inclisiran in Children With Homozygous Familial Hypercholesterolemia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Two Part Double-blind Inclisiran Versus Placebo Year 1 Followed by Open-label Inclisiran Year 2 Randomized Multicenter Study to Evaluate Safety Tolerability and Efficacy of Inclisiran in Children 2 to Less Than 12 Years With Homozygous Familial Hypercholesterolemia and Elevated LDL-cholesterol
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ORION-19
Brief Summary:
This is a pivotal phase III study designed to evaluate safety tolerability and efficacy of inclisiran in children aged 2 to 12 years with homozygous familial hypercholesterolemia HeFH and elevated low density lipoprotein cholesterol LDLC
Detailed Description:
This is a two-part 1 year double-blind inclisiran versus placebo 1 year open-label inclisiran multicenter study designed to evaluate safety tolerability and efficacy of inclisiran in children aged 2 to 12 years with homozygous familial hypercholesterolemia HeFH and elevated low density lipoprotein cholesterol LDL-C on stable standard of care background lipid-lowering therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None