A Compassionate Use Program to Provide Access to Sodium Thiosulfate

September 15, 2021 updated by: TRPHARM

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

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.

Study Overview

Status

Available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Individual Patients

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Ankara, Turkey
        • Available
        • Ankara University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 18 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

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 Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TRPHARM

Collaborators

Fennec Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

October 16, 2019

First Submitted That Met QC Criteria

October 16, 2019

First Posted (Actual)

October 21, 2019

Study Record Updates

Last Update Posted (Actual)

September 16, 2021

Last Update Submitted That Met QC Criteria

September 15, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRP-STS-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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

  • University of California, San Francisco
    Patient-Centered Outcomes Research Institute
    Recruiting
    Preschool Hearing Screening
    Hearing Loss | Hearing Loss, Sensorineural | Hearing Loss, Bilateral | Hearing Loss, Conductive | Hearing Loss, Noise-Induced | Hearing Loss, Unilateral | Hearing Loss, Mixed | Hearing Disorders in Children
    United States

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