A Multi-centre Open-label Randomised Phase III Trial of the Efficacy of Sodium Thiosulphate in Reducing Ototoxicity in Patients Receiving Cisplatin Chemotherapy for Standard Risk Hepatoblastoma

Trial Profile

A Multi-centre Open-label Randomised Phase III Trial of the Efficacy of Sodium Thiosulphate in Reducing Ototoxicity in Patients Receiving Cisplatin Chemotherapy for Standard Risk Hepatoblastoma

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 13 Nov 2017

At a glance

  • Drugs Sodium thiosulfate (Primary) ; Cisplatin
  • Indications Sensorineural hearing loss
  • Focus Therapeutic Use
  • Acronyms SIOPEL-6
  • Most Recent Events

    • 13 Nov 2017 According to a Fennec Pharmaceuticals media release,Company plans to pursue regulatory approvals with FDA and EU in 2018.
    • 16 Oct 2017 Results presented in a Fennec Pharmaceuticals media release.
    • 16 Oct 2017 Primary endpoint (Rate of Brock grade 1 hearing loss determined after end of trial treatment or at an age of at least 3.5 years) has been met, according to a Fennec Pharmaceuticals media release.
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