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A Randomized Phase III Study of Sodium Thiosulfate for the Prevention of Cisplatin-Induced Ototoxicity in Children

Trial Profile

A Randomized Phase III Study of Sodium Thiosulfate for the Prevention of Cisplatin-Induced Ototoxicity in Children

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Aug 2019

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At a glance

  • Drugs Sodium thiosulfate (Primary)
  • Indications Sensorineural hearing loss
  • Focus Registrational; Therapeutic Use
  • Most Recent Events

    • 09 Aug 2019 According to a Fennec media release, the company anticipates the completion of NDA filing by early 2020.
    • 31 Aug 2018 Biomarkers information updated
    • 27 Mar 2018 According to Fennec media release, Based on data from SIOPEL 6 and COG ACCL0431 studies, the U.S. Food and Drug Administration (FDA) has granted PEDMARK (a unique formulation of sodium thiosulfate) Breakthrough Therapy designation for prevention of cisplatin-related ototoxicity in pediatric patients with standard risk hepatoblastoma (SR-HB).
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