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: 12 May 2017

At a glance

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

    • 12 May 2017 According to a Fennec Pharmaceuticals media release, the company is preparing for NDA/MAA submissions to USFDA and EMA respectively, based on the data from this trial which is expected in October 2017.
    • 14 Nov 2016 According to a Fennec Pharmaceuticals media release, the final audiometry results from this trial will be reported in the fourth quarter of 2017.
    • 24 Oct 2016 Updated interim results presented at the International Society of Paediatric Oncology (SIOP) 2016 Meeting, according to a Fennec Pharmaceuticals media release.
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