Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04863014
Status:
TERMINATED
Last Update Posted:
2024-05-22
First Post:
2021-04-26
Brief Title:
Efficacy and Safety of Evinacumab in Adult Patients With Severe Hypertriglyceridemia for the Prevention of Recurrent Acute Pancreatitis
Sponsor:
Regeneron Pharmaceuticals
Organization:
Regeneron Pharmaceuticals
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Evinacumab in Patients With Severe Hypertriglyceridemia for the Prevention of Recurrent Acute Pancreatitis
Status:
TERMINATED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor Decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of the study is to determine the proportion of patients with elevated triglycerides TG without familial chylomicronemia syndrome FCS due to loss of function LoF mutations in lipoprotein lipase LPL and a history of hypertriglyceridemia HTG-associated acute pancreatitis AP who experience a recurrent episode of AP after treatment with evinacumab versus placebo
The secondary objectives of the study are
To determine the change in the standard lipid profile after therapy with evinacumab versus placebo
To determine the changes in specialty lipoprotein parameters ApoC3 ApoB48 ApoB100 and nuclear magnetic resonance NMR lipid profile after therapy with evinacumab versus placebo
To measure the number of AP episodes per patient
To assess the safety and tolerability of evinacumab
To assess the potential immunogenicity of evinacumab
To assess the concentrations of total evinacumab and total angiopoietin-like 3 ANGPTL3
The secondary objectives of the study are
To determine the change in the standard lipid profile after therapy with evinacumab versus placebo
To determine the changes in specialty lipoprotein parameters ApoC3 ApoB48 ApoB100 and nuclear magnetic resonance NMR lipid profile after therapy with evinacumab versus placebo
To measure the number of AP episodes per patient
To assess the safety and tolerability of evinacumab
To assess the potential immunogenicity of evinacumab
To assess the concentrations of total evinacumab and total angiopoietin-like 3 ANGPTL3
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 |
|---|---|---|---|
| 2021-000437-13 | EUDRACT_NUMBER | None | None |