A PHASE 1/2, OPEN-LABEL, MULTICENTER TRIAL WITH A SINGLE ASCENDING DOSE COHORT WITH UNILATERAL INTRACOCHLEAR INJECTION FOLLOWED BYA BILATERAL INJECTION EXPANSION COHORT TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF DB-OTO IN CHILDREN AND INFANTS WITHBIALLELIC hOTOF MUTATIONS
Sponsor: |
Decibel Therapeutics Inc. |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAU2963 |
U.S. Govt. ID: |
NCT05788536 |
Contact: |
Nathalie Moreno: 212-305-2298 / nmm2206@cumc.columbia.edu |
The CHORD clinical trial, sponsored by Decibel Therapeutics, is looking at the use of the gene therapy DB-OTO for children born with hearing loss related to changes in the OTOF gene. The goal of this trial is to assess different doses of DB-OTO to find out if it is safe, well-tolerated, and its effect on improving hearing. DB-OTO is a gene therapy that has been created to deliver a working version of the OTOF gene into the inner ear. DB-OTO is injected into the cochlea, located within the inner ear during a surgical procedure that is similar to cochlear implant surgery.
Investigator
Lawrence Lustig, MD
Is your child 17 years old or younger? |
Yes |
No |
Was your child born with hearing loss that is due to a confirmed OTOF genetic mutation? |
Yes |
No |
Does your child have at least one ear that has not already received a cochlear implant? |
Yes |
No |