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
Phase of Trial: Phase III
Latest Information Update: 29 Aug 2019
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At a glance
- Drugs Sodium thiosulfate (Primary)
- Indications Sensorineural hearing loss
- Focus Registrational; Therapeutic Use
- Acronyms SIOPEL6
- 09 Aug 2019 According to a Fennec media release, the company anticipates the completion of NDA filing by early 2020.
- 28 Feb 2019 This trial has been completed in United Kingdom, according to European Clinical Trials Database.
- 04 Feb 2019 According to the Fennec Pharmaceuticals media release, In Europe, PEDMARK has been accepted by the EMA for Marketing Authorization Application submission via the PUMA pathway.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History