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

NCT06722170 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-07-25

No results posted yet for this study

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.

Conditions

  • DFNB9
  • Congenital Hearing Loss
  • Hearing Loss, Sensorineural

Interventions

GENETIC

EH002 administration

EH002 was administered into one or both ears via intracochlear injection.

Sponsors & Collaborators

  • Yilai Shu

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-22
Primary Completion
2027-11-30
Completion
2029-11-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06722170 on ClinicalTrials.gov