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Gene Therapy for Congenital Hearing Loss (CHORD Trial)
CHORD Trial Summary
This trial tests a gene therapy to help kids with a genetic disorder. It assesses safety, tolerability & efficacy of the therapy.
CHORD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCHORD Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.CHORD Trial Design
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Who is running the clinical trial?
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- I have had meningitis before.I have had cancer before or have it now.My child's inner ear function is confirmed normal for DB-OTO treatment.My child has severe hearing loss diagnosed by tests.My child's ears can produce sounds in response to a test, and they are 24 months old or younger.My child's ear function for hearing has been confirmed to be normal.My child has detectable inner ear responses and is between 2 and 18 years old.Your recent lab tests don't show any important health problems.My ear structure allows for the planned surgery based on my scans.My child under 2 years doesn't respond to certain sounds and is in the UK or Spain.My child has severe hearing loss and struggles to understand words.My child does not respond to certain sounds and is between 2 and 18 years old.You have had a cochlear implant in the ear where the study drug will be injected.I am under 18 and fit the age group needed for this study.I have permanent hearing loss not related to treatment.Your hearing loss is not affected by changes in body temperature.I agree to use effective birth control and not to conceive or father a child.I have previously undergone gene therapy.I have risk factors for hearing issues not due to genetic causes, such as being born early or with low weight.The doctor decides that the patient is a good candidate for cochlear implants in both ears based on the recommended guidelines for cochlear implants.I have genetic mutations in both copies of my OTOF gene.The doctor decides that using a hearing aid won't be very helpful for you.
- Group 1: DB-OTO - Dose Escalation
- Group 2: DB-OTO - Dose Expansion
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the capacity of this research endeavor?
"Affirmative, records on clinicaltrials.gov show that this research trial is currently recruiting participants. It was first published on May 12th 2023 and has been amended as recently as June 14th 2023. The experiment requires 22 individuals to be enrolled at 4 distinct facilities."
Are there still open positions for participants in this research?
"Affirmative. According to the clinical trial data hosted on clinicialtrials.gov, this medical study is actively recruiting participants since its initial postdate of May 12th 2023 and last edit date of June 14th 2023. 22 individuals need to be enrolled from 4 distinct locations."
Are any North American medical sites conducting this research project?
"At the present moment, this study is recruiting patients from 4 sites: Los Angeles, Madrid, Cambridge and a further 4. It's prudent to pick the closest site in order to minimize travel needs if one chooses to partake."
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