Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06594016
Status:
AVAILABLE
Last Update Posted:
None
First Post:
2024-09-10
Brief Title:
Expanded Access to Fosigotifator
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Expanded Access to Fosigotifator
Status:
AVAILABLE
Status Verified Date:
2024-08
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:
None
Brief Summary:
This is an expanded access program EAP for eligible participants This program is designed to provide access to Fosigotifator prior to approval by the local regulatory agency Availability will depend on territory eligibility A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patients medical history and program eligibility criteria
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: