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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 26 Dec 2024

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At a glance

  • Drugs Sodium thiosulfate (Primary)
  • Indications Sensorineural hearing loss
  • Focus Registrational; Therapeutic Use
  • Acronyms SIOPEL6
  • Sponsors Fennec Pharmaceuticals

Most Recent Events

  • 20 Dec 2024 According to a Fennec Pharmaceuticals media release, company announced that Norgine Pharmaceuticals Ltd. has received positive final draft guidance from National Institute for Health and Care Excellence (NICE) recommending PEDMARQSI for the prevention of cisplatin-induced hearing loss in patients (aged 1 month to 17 years) with localized, non-metastatic, solid tumors.
  • 01 Oct 2023 According to a Fennec Pharmaceuticals media release, the company received approval from the MHRA in UK for PEDMARK (sodium thiosulfate injection).
  • 06 Jun 2023 According to a Fennec Pharmaceuticals media release, the company received marketing authorization by the European Commission for Pedmarqsi (sodium thiosulfate) in pediatric patients with localized, non-metastatic solid tumors, based on SIOPEL 6 and Clinical Oncology Group [COG] Protocol ACCL0431). The marketing authorization is applicable to all 27 European Union member states, as well as Iceland, Norway and Liechtenstein.

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