Spots Global Cancer Trial Database for A Compassionate Use Program to Provide Access to Sodium Thiosulfate

Study Description

Brief Summary: This is a CUP which is designed to provide treatment access of STS to pediatric patients for the protection from Cisplatin-Induced Hearing Loss in children who had standard-risk hepatoblastoma. Approximately 10 patients will be treated as part of this program as specified below: Sodium Thiosulfate vials i.v. 80 mg/mL. This Compassionate Use Program for STS will consist of 2 phases: Screening: Patients will only be able to participate in this CUP if they meet the eligibility criteria. Treatment: Any clinical assessments, physical examinations, and dosage changes will be determined by the treating physician as per local standard medical practice. All serious adverse events (SAEs) will be reported. All related non-serious adverse events (AEs) will be reported where "related" means any event where a causal relationship between STS and the event is at least, a reasonable possibility. All non-serious AEs leading to dose modification or discontinuation will be reported. Pregnancies, outcomes of pregnancies, and exposure through breastfeeding will also be reported.

Detailed Description:

Keywords

Eligibility

Minimum Age: 1 Month

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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