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
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History