Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-02-25 @ 8:59 PM
Study NCT ID:
NCT01954394
Status:
COMPLETED
Last Update Posted:
2018-07-24
First Post:
2013-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Open Label Study of Long Term Safety Evaluation of Alirocumab
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
Open-Label Extension Study of EFC12492, R727-CL-1112, EFC12732 and LTS11717 Studies to Assess the Long-Term Safety and Efficacy of Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia
Status:
COMPLETED
Status Verified Date:
2018-06
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:
ODYSSEY OLE
Brief Summary:
Primary Objective:
To assess the long-term safety of alirocumab (SAR236553/REGN727) when added to lipid-lowering therapy in participants with heterozygous familial hypercholesterolemia (heFH) who had completed EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500), EFC12732 (NCT01617655) and LTS11717 (NCT01507831).
Secondary Objectives:
* To evaluate the long-term efficacy of alirocumab on lipid parameters.
* To evaluate the long-term immunogenicity of alirocumab.
To assess the long-term safety of alirocumab (SAR236553/REGN727) when added to lipid-lowering therapy in participants with heterozygous familial hypercholesterolemia (heFH) who had completed EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500), EFC12732 (NCT01617655) and LTS11717 (NCT01507831).
Secondary Objectives:
* To evaluate the long-term efficacy of alirocumab on lipid parameters.
* To evaluate the long-term immunogenicity of alirocumab.
Detailed Description:
The maximum study duration will be 176 weeks per participant.
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?: