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

Completed
Phase of Trial: Phase III

Latest Information Update: 27 Mar 2018

At a glance

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

    • 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).
    • 10 Jun 2017 Biomarkers information updated
    • 01 Dec 2016 Status changed from active, no longer recruiting to completed, according to a Fennec Pharmaceuticals media release.
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