Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06360237
Status:
AVAILABLE
Last Update Posted:
2024-04-11
First Post:
2024-04-06
Brief Title:
Olezarsen Early Access Program for Patients With Familial Chylomicronemia Syndrome FCS
Sponsor:
Ionis Pharmaceuticals Inc
Organization:
Ionis Pharmaceuticals Inc
Study Overview
Official Title:
Olezarsen ISIS 678354 Early Access Program for Patients With Familial Chylomicronemia Syndrome FCS
Status:
AVAILABLE
Status Verified Date:
2024-08
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:
None
Brief Summary:
The purpose of the Expanded Access Program is to provide pre-approval access of olezarsen to eligible patients with Familial Chylomicronemia Syndrome FCS
Detailed Description:
The Expanded Access Program EAP is intended to provide pre-approval access to olezarsen for eligible patients with FCS who have limited or no available treatment options This program is open in the United States and operates under the individual patient also referred to as single patient IND expanded access route in which the patients treating physician serves as the sponsor Expanded access requests must be from the patients treating physicians and submitted according to the instructions at httpswwwionispharmacompatientsexpanded-access-policy
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