Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04519749
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-08
First Post:
2020-08-14
Brief Title:
An Open-label Phase 12 Trial of Gene Therapy 4D-310 in Adults With Fabry Disease
Sponsor:
4D Molecular Therapeutics
Organization:
4D Molecular Therapeutics
Study Overview
Official Title:
An Open-label Phase 12 Trial of Gene Therapy 4D-310 in Adults With Fabry Disease
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
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:
This is a prospective multicenter open-label dose-escalation trial to assess the safety tolerability and pharmacodynamics of 4D-310 following a single IV administration The study population is comprised of adult males and females with Fabry Disease
Detailed Description:
This is a prospective multicenter open-label dose-escalation trial to assess the safety tolerability and pharmacodynamics of 4D-310 following a single IV administration The study population is comprised of adult males and females with Fabry Disease
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