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A Phase I/II, Open-ended, Adaptative, Open Label Dose Escalation and Expansion Clinical Trial to Evaluate the Efficacy and Safety of Unilateral Intracochlear Injection of SENS-501 Using an Injection System in Children with Severe to Profound Hearing Loss Due to Otoferlin Gene Mutations

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A Phase I/II, Open-ended, Adaptative, Open Label Dose Escalation and Expansion Clinical Trial to Evaluate the Efficacy and Safety of Unilateral Intracochlear Injection of SENS-501 Using an Injection System in Children with Severe to Profound Hearing Loss Due to Otoferlin Gene Mutations

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 01 Apr 2025

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At a glance

  • Drugs OTOF GT (Primary)
  • Indications Deafness
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms AUDIOGENE
  • Sponsors Sensorion

    • Most Recent Events

    • 14 Mar 2025 According to a Sensorion media release, the company plans to complete recruitment of the second cohort of patients and on hosting a KOL event to present new data in H1 2025.
    • 21 Feb 2025 According to a Sensorion media release, Recruitment of the second cohort (three patients) is expected to be completed by the end of the first half of 2025.
    • 21 Feb 2025 According to a Sensorion media release,the Data Monitoring Committee (DMC) recommended the continuation of the Audiogene Phase 1/2 clinical trial of SENS-501 based on favourable safety profile of SENS-501.

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