- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
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
Intervention / Treatment
Study Type
Expanded Access Type
- Individual Patients
Contacts and Locations
Study Contact
- Name: Serdar Altinel
- Phone Number: 00902123863149
- Email: serdar.altinel@trpharm.com
Study Locations
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Ankara, Turkey
- Available
- Ankara University School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
How is the study designed?
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neurologic Manifestations
- Otorhinolaryngologic Diseases
- Ear Diseases
- Neoplasms, Complex and Mixed
- Sensation Disorders
- Hearing Disorders
- Hearing Loss
- Deafness
- Hepatoblastoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Protective Agents
- Anti-Bacterial Agents
- Antioxidants
- Antidotes
- Antitubercular Agents
- Chelating Agents
- Sequestering Agents
- Sodium thiosulfate
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
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