Ignite Creation Date:
2024-05-06 @ 10:04 AM
Last Modification Date:
2024-10-26 @ 12:24 PM
Study NCT ID:
NCT03156621
Status:
COMPLETED
Last Update Posted:
2021-06-29
First Post:
2017-05-15
Brief Title:
Study in Participants With Homozygous Familial Hypercholesterolemia HoFH
Sponsor:
Regeneron Pharmaceuticals
Organization:
Regeneron Pharmaceuticals
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Parallel-Group Study to Evaluate the Efficacy and Safety of Alirocumab in Patients With Homozygous Familial Hypercholesterolemia
Status:
COMPLETED
Status Verified Date:
2021-06
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 HoFH
Brief Summary:
The primary objective of the study is to demonstrate the reduction of low-density lipoprotein cholesterol LDL-C with alirocumab subcutaneous SC every 2 weeks Q2W in comparison to placebo after 12 weeks of treatment
The secondary objectives of the study are
To evaluate the effect of alirocumab Q2W on other lipid parameters ie apolipoprotein Apo A-1 and B non-high-density lipoprotein cholesterol non-HDL-C total-cholesterol TC proportion of participants with 15 30 and 50 LDL-C reductions Lpa HDL-C triglycerides TG in participants with HoFH
To evaluate the safety and tolerability of alirocumab SC Q2W in participants with HoFH
To assess the pharmacokinetics of alirocumab SC Q2W in participants with HoFH
To assess the potential development of anti-drug alirocumab antibodies
The secondary objectives of the study are
To evaluate the effect of alirocumab Q2W on other lipid parameters ie apolipoprotein Apo A-1 and B non-high-density lipoprotein cholesterol non-HDL-C total-cholesterol TC proportion of participants with 15 30 and 50 LDL-C reductions Lpa HDL-C triglycerides TG in participants with HoFH
To evaluate the safety and tolerability of alirocumab SC Q2W in participants with HoFH
To assess the pharmacokinetics of alirocumab SC Q2W in participants with HoFH
To assess the potential development of anti-drug alirocumab antibodies
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2017-000351-95 | EUDRACT_NUMBER | None | None |