Cisplatin-Induced Hearing Loss in Children Who Had Standard-risk HepatoblastomaNCT04132882
A Compassionate Use Program to Provide Access to Sodium Thiosulfate
A study testing Sodium Thiosulfate (STS) in people with Cisplatin-Induced Hearing Loss in Children Who Had Standard-risk Hepatoblastoma, run by TRPHARM at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Cisplatin-Induced Hearing Loss in Children Who Had Standard-risk Hepatoblastoma
- What is being tested?
- Sodium Thiosulfate (STS)
- How many people
- Not given
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
- Available
Ankara University School of Medicine
Ankara
About this study
Official title: 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:
Read more
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.
- Being tested
- Sodium Thiosulfate (STS)
- Keywords
- Cisplatin, Hearing Loss, Hepatoblastoma
- Medical subject headings
- Hearing Loss, Hepatoblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Thiosulfate (STS)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cisplatin-Induced Hearing Loss in Children Who Had Standard-risk HepatoblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- TRPHARM
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fennec Pharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04132882
- Sponsor's protocol ID
- TRP-STS-001
- Status last verified
- Sep 2021
- First submitted
- 16 Oct 2019
- Last updated
- 16 Sep 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04132882
- Acronym / sponsor ID
- TRP-STS-001
- Keywords
- Cisplatin, Hearing Loss, Hepatoblastoma
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- TRPHARMIndustry (pharma, biotech, devices)
- Collaborators
- Fennec Pharma
- First posted
- 21 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium Thiosulfate (STS) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium Thiosulfate (STS) in people with Cisplatin-Induced Hearing Loss in Children Who Had Standard-risk Hepatoblastoma, run by TRPHARM at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Serdar Altinel (00902123863149, serdar.altinel@trpharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.