NCT04132882

A Compassionate Use Program to Provide Access to Sodium Thiosulfate

A Compassionate Use Program to Provide Access to Sodium Thiosulfate for the Protection From Cisplatin-Induced Hearing Loss in Children Who Had Standard-risk Hepatoblastoma

• Status: Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: TRPHARM · Industry
• Sex: All
• Age: 1 Month – 18 Years
• Healthy volunteers: —

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.

Conditions

• Cisplatin-Induced Hearing Loss in Children Who Had Standard-risk Hepatoblastoma

Interventions

Type	Name	Description
DRUG	Sodium Thiosulfate (STS)

Timeline

• First posted: 2019-10-21
• Last updated: 2021-09-16

Locations

1 site across 1 country: Turkey (Türkiye)