A Natural History Study in Pediatric Participants With Hearing Loss Due to OTOF, GJB2, or GJB2/GJB6 Mutations

NCT06019481 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2025-05-15

No results posted yet for this study

Summary

This is an observational study to examine the characteristics of gene-related hearing loss in pediatric participants with biallelic otoferlin (OTOF) Mutations, Gap Junction Beta 2 (GJB2) Mutations, or Digenic GJB2/Gap Junction Beta 6 (GJB6) Mutations. This study will follow the participant for 4 years with annual visits each year.

Conditions

  • Congenital Hearing Loss Secondary to Biallelic Mutations in the Otoferlin Gene (OTOF)
  • Biallelic Mutations in the Gap Junction Beta 2 (GJB2) Gene
  • Digenic Mutations in GJB2/Gap Junction Beta 6 (GJB6) Genes

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Eligibility

Max Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-30
Primary Completion
2030-06-30
Completion
2030-06-30

Countries

  • United States

Study Locations

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Entities

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 NCT06019481 on ClinicalTrials.gov