Ignite Creation Date:
2024-05-06 @ 6:46 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05788536
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2023-03-15
Brief Title:
A Study of DB-OTO an Adeno-associated Virus AAV Based Gene Therapy in ChildrenInfants With Hearing Loss Due to Otoferlin Mutations
Sponsor:
Regeneron Pharmaceuticals
Organization:
Regeneron Pharmaceuticals
Study Overview
Official Title:
A PHASE 12 OPEN-LABEL MULTICENTER TRIAL WITH A SINGLE ASCENDING DOSE COHORT WITH UNILATERAL INTRACOCHLEAR INJECTION FOLLOWED BY A BILATERAL INJECTION EXPANSION COHORT TO EVALUATE THE SAFETY TOLERABILITY AND EFFICACY OF DB-OTO IN CHILDREN AND INFANTS WITH BIALLELIC hOTOF MUTATIONS
Status:
RECRUITING
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:
CHORD
Brief Summary:
Regeneron is conducting a study of an investigational new drug called DB-OTO DB-OTO is a gene therapy that is being developed to treat children who have hearing loss due to changes in the otoferlin gene
The purpose of this study is to
Learn about the safety of DB-OTO
Determine how well DB-OTO is tolerated does not cause ongoing discomfort
Evaluate the efficacy of DB-OTO how well DB-OTO works
The purpose of this study is to
Learn about the safety of DB-OTO
Determine how well DB-OTO is tolerated does not cause ongoing discomfort
Evaluate the efficacy of DB-OTO how well DB-OTO works
Detailed Description:
Former Sponsor Decibel Therapeutics
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 |
|---|---|---|---|
| 2022-000079-38 | EUDRACT_NUMBER | None | None |