Clinical Trial

A Study of EH002 Gene Therapy for Otoferlin Gene Mutation-mediated Hearing Loss

Recruiting
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Summary
The study is designed to evaluate the safety, tolerability, and preliminary efficacy of EH002 for the treatment of congenital deafness caused by mutations in the OTOF gene. Participants may receive one or two injections of the EH002 gene therapy in one or both ears.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2024-12-05; most recent amendment 2025-07-22.
Status change: Not Yet Recruiting → Recruiting 2024-12-12
Trial Details
NCT Number NCT06722170
Lead Sponsor Yilai Shu
Conditions DFNB9, Congenital Hearing Loss, Hearing Loss, Sensorineural
Enrollment 24 participants
Start Date 2024-11-22
Primary Completion 2027-11 (estimated)
Study Completion 2029-11 (estimated)
Updated on ClinicalTrials.gov 2025-07-25