Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06597656
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
A Gene Transfer Therapy to Evaluate the Safety and Efficacy of Delandistrogene Moxeparvovec SRP-9001 Following Therapeutic Plasma Exchange Plasmapheresis in Participants With Duchenne Muscular Dystrophy DMD and Pre-existing Antibodies to AAVrh74
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open-Label Systemic Gene Delivery Study to Evaluate the Safety Tolerability and Expression of Delandistrogene Moxeparvovec Following Plasmapheresis in Subjects With Duchenne Muscular Dystrophy and Pre-existing Antibodies to AAVrh74
Status:
RECRUITING
Status Verified Date:
2024-10
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:
HORIZON
Brief Summary:
This is a gene transfer therapy study evaluating the safety of and delandistrogene moxeparvovec dystrophin protein expression from delandistrogene moxeparvovec following therapeutic plasma exchange plasmapheresis in ambulatory male participants with DMD and pre-existing antibodies to AAVrh74 over a period of 58 weeks
Detailed Description:
None
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