A Compassionate Use Program to Provide Access to Sodium Thiosulfate

Status:

AVAILABLE

A Compassionate Use Program to Provide Access to Sodium Thiosulfate

Lead Sponsor:

TRPHARM

Collaborating Sponsors:

Fennec Pharma

Conditions:

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

Eligibility:

All Genders

1-18 years

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. Appro...

Eligibility Criteria

Inclusion

I-1. Children older than 1 month and younger than 18 years of age who had standard-risk hepatoblastoma that had not been treated previously with STS and receive cisplatin.
I-2. A written informed consent was provided from all the patients and/or parents or legal guardians of children.

Exclusion

E-1. Any previous participation in an STS clinical trial. E-2. Participation in another clinical study with an investigational product during the most recent chemotherapy course.
E-3. Patients with a known hypersensitivity to STS or any of the excipients of the product.
E-4. Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) or major surgery within 3 weeks prior to STS treatment.
E-5. Persistent toxicities (\>Common Terminology Criteria for Adverse Event (CTCAE) CTCAE grade 2) caused by previous cancer therapy, excluding alopecia.
E-6. Breast feeding or pregnant women.

Key Trial Info

Start Date :

Trial Type :

EXPANDED_ACCESS

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT04132882

Last Update

September 16 2021

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