Manganese Safety in Pediatric PatientsPhase 4NCT05677126
Tralement vs. Fixed-dose Trace Element Combination Product in Patients >3 to 17 Years of Age Requiring Long-term PN
A Phase 4 study testing Tralement and Fixed-dose trace element combination product of zinc, copper, and selenious acid in people with Manganese Safety in Pediatric Patients, run by American Regent, Inc..
Trial summary
Tralement versus a fixed-dose trace element combination product of zinc, copper, and selenious acid to evaluate product safety in pediatric patients >3 to 17 years of age requiring long-term parenteral nutrition. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Manganese Safety in Pediatric Patients
- What is being tested?
- Tralement and Fixed-dose trace element combination product of zinc, copper, and selenious acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to 26 Aug 2024
- Phase
- Phase 4
- 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 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric (≥3 to 17 years of age) participants weighing >10 kg with assent to participation and his/her parent or legal guardian is willing and able to sign the informed consent approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC).
- Male and female participants who are new users to home parenteral nutrition as a source of trace elements when oral or enteral nutrition is not possible, insufficient, or, contraindicated.
- Anticipated duration of home parenteral nutrition use is 6 months or greater.
- A normal baseline brain MRI scan.
- A normal blood manganese concentration.
- Ability to undergo additional 2 brain MRI scans over the six-month study period (Sedation, if appropriate, to be determined by the Principal Investigator's study site, institutional review board recommendations, and parent/guardian assent).
- Definitive contraception for females of reproductive age.
Who cannot join
- Prior parenteral nutrition therapy.
- Hypersensitivity or allergy to zinc or copper.
- Baseline ferritin ≥300 ng/mL or below 100 ng/mL.
- Baseline Transferrin Saturation (TSAT) ≥45% or below 20%.
- Prior or current cholestatic liver disease defined as a clinical condition associated with decrease in bile flow due to impaired secretion by hepatocytes or to obstruction of bile flow through intra-or extrahepatic bile ducts.
- Liver function studies with transaminases greater than two-fold normal or total bilirubin >2 mg/dL.
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- Brain MRI exclusion criteria: MRI-unsafe metal implants, claustrophobia.
- Known excess environmental exposure to manganese.
- Less than 1-year expected survival, as anticipated by their primary provider.
- Current participation in another clinical trial.
- Females in pregnant state.
About this study
Official title: A Randomized, Single-blind, Trial of Tralement Versus a Fixed-dose Trace Element Combination Product of Zinc, Copper, and Selenious Acid to Evaluate Manganese Safety in Pediatric Patients Requiring Long-term Parenteral Nutrition
Tralement versus a fixed-dose trace element combination product of zinc, copper, and selenious acid to evaluate product safety in pediatric patients >3 to 17 years of age requiring long-term parenteral nutrition.
Read the detailed description
A Phase IV, multi-center, randomized single-blind trial to evaluate the safety profile of Tralement versus a fixed-dose trace element product of zinc, copper, and selenious acid in pediatric patients who are expected to require at least six-months of home parenteral nutrition.
This study will enroll new prescribed home parenteral nutrition users, i.e. a patient enrolled in the study within six weeks of initiating first-time use of parenteral nutrition requiring trace element additives. Note: a portion of patients who meet inclusion criteria may have received parenteral nutrition in an inpatient setting before discharge home.
Eligible participants who satisfy the inclusion requirements and no exclusion criteria will be consented to participate in this study and enter the screening study phase.
The screening evaluation will be conducted within 5 days of the dose administration of study drug. Study participants meeting entry criteria of normal brain MRI and laboratory manganese concentrations (whole blood/plasma/serum/RBC) will begin study drug on Day 1.
Participants will undergo 2 additional post-baseline brain MRI scans at Months 3 and 6 and have either 2 (3.5-<7 years of age) and 4 (7-16 years of age) separate neuropsychological tests at Day 1, Month 3, and Month 6. Additional clinical monitoring including safety and laboratory assessments will occur during the 6-month opt-in extension study.
All patients in each assigned trace element parenteral nutrition group will have parenteral nutrition formulations evaluated for manganese content at Day 1, Month 1, Month 3, and Month 6.
- Conditions
- Manganese Safety in Pediatric Patients
- Being tested
- Tralement, Fixed-dose trace element combination product of zinc, copper, and selenious acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TralementDrug
Also called trace elements (zinc sulfate, cupric sulfate, manganese sulfate and selenious acid)
Tralement with Manganese
Fixed-dose trace element combination product of zinc, copper, and selenious acidDrug
Also called trace elements (zinc sulfate, cupric sulfate, manganese sulfate and selenious acid)
Tralement without Manganese
| Study group | Role | What they receive |
|---|---|---|
| Tralement | Active comparator | This study will enroll new prescribed home parenteral nutrition users, i.e. a patient enrolled in the study within six weeks of initiating first-time use of long-term home parenteral nutrition requiring trace element additives. Note: a portion of patients who meet inclusion criteria may have received parenteral nutrition in an inpatient setting before discharge home. Receives: Drug: Tralement |
| a fixed-dose trace element combination product of zinc, copper, and selenious acid | Active comparator | This study will enroll new prescribed home parenteral nutrition users, i.e. a patient enrolled in the study within six weeks of initiating first-time use of long-term home parenteral nutrition requiring trace element additives. Note: a portion of patients who meet inclusion criteria may have received parenteral nutrition in an inpatient setting before discharge home. Receives: Drug: Fixed-dose trace element combination product of zinc, copper, and selenious acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess efficacy of brain deposition of manganese in Tralement versus a fixed-dose trace element product of zinc, copper, and selenious acid.
Change from baseline in basal ganglia index (BG-index) as determined by T1-weighted brain MRI images
Measured: Six months
Secondary outcomes (2)
To assess the efficacy of Tralement versus a fixed-dose trace element product of zinc, copper, and selenious acid.
Change from baseline in blood (plasma/serum/RBC) manganese levels
Measured: Six months
To assess the safety of Tralement versus a fixed-dose trace element product of zinc, copper, and selenious acid
- Change from baseline in BG-index and pallidal index as determined by T1-weighted brain MRI images
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study startAug 2024 (estimated)
- Primary completionAug 2024 (estimated)
- Study completion26 Aug 2024
Why it stopped: The Tralement Pediatric Safety Study has faced significant challenges in site recruitment and feasibility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Manganese Safety in Pediatric PatientsStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Regent, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Falone, MD, Study director, Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05677126
- Sponsor's protocol ID
- TE20002
- Status last verified
- Aug 2024
- First submitted
- 13 Dec 2022
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-blind, Trial of Tralement Versus a Fixed-dose Trace Element Combination Product of Zinc, Copper, and Selenious Acid to Evaluate Manganese Safety in Pediatric Patients Requiring Long-term Parenteral Nutrition
- ClinicalTrials.gov ID
- NCT05677126
- Acronym / sponsor ID
- TE20002
- Conditions
- Manganese Safety in Pediatric Patients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The Tralement Pediatric Safety Study has faced significant challenges in site recruitment and feasibility
- Enrolment
- 0 participants (actual)
- Lead sponsor
- American Regent, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2024 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- 26 Aug 2024 (actual)
- First posted
- 10 Jan 2023 (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.
Tralement versus a fixed-dose trace element combination product of zinc, copper, and selenious acid to evaluate product safety in pediatric patients >3 to 17 years of age requiring long-term parenteral nutrition.
Detailed description
A Phase IV, multi-center, randomized single-blind trial to evaluate the safety profile of Tralement versus a fixed-dose trace element product of zinc, copper, and selenious acid in pediatric patients who are expected to require at least six-months of home parenteral nutrition.
This study will enroll new prescribed home parenteral nutrition users, i.e. a patient enrolled in the study within six weeks of initiating first-time use of parenteral nutrition requiring trace element additives. Note: a portion of patients who meet inclusion criteria may have received parenteral nutrition in an inpatient setting before discharge home.
Eligible participants who satisfy the inclusion requirements and no exclusion criteria will be consented to participate in this study and enter the screening study phase.
The screening evaluation will be conducted within 5 days of the dose administration of study drug. Study participants meeting entry criteria of normal brain MRI and laboratory manganese concentrations (whole blood/plasma/serum/RBC) will begin study drug on Day 1.
Participants will undergo 2 additional post-baseline brain MRI scans at Months 3 and 6 and have either 2 (3.5-<7 years of age) and 4 (7-16 years of age) separate neuropsychological tests at Day 1, Month 3, and Month 6. Additional clinical monitoring including safety and laboratory assessments will occur during the 6-month opt-in extension study.
All patients in each assigned trace element parenteral nutrition group will have parenteral nutrition formulations evaluated for manganese content at Day 1, Month 1, Month 3, and Month 6.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tralement | Active comparator | Drug: TralementThis study will enroll new prescribed home parenteral nutrition users, i.e. a patient enrolled in the study within six weeks of initiating first-time use of long-term home parenteral nutrition requiring trace element additives. Note: a portion of patients who meet inclusion criteria may have received parenteral nutrition in an inpatient setting before discharge home. |
| a fixed-dose trace element combination product of zinc, copper, and selenious acid | Active comparator | Drug: Fixed-dose trace element combination product of zinc, copper, and selenious acidThis study will enroll new prescribed home parenteral nutrition users, i.e. a patient enrolled in the study within six weeks of initiating first-time use of long-term home parenteral nutrition requiring trace element additives. Note: a portion of patients who meet inclusion criteria may have received parenteral nutrition in an inpatient setting before discharge home. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Pediatric (≥3 to 17 years of age) participants weighing >10 kg with assent to participation and his/her parent or legal guardian is willing and able to sign the informed consent approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC).
- Male and female participants who are new users to home parenteral nutrition as a source of trace elements when oral or enteral nutrition is not possible, insufficient, or, contraindicated.
- Anticipated duration of home parenteral nutrition use is 6 months or greater.
- A normal baseline brain MRI scan.
- A normal blood manganese concentration.
Key exclusion criteria (11 listed)
- Prior parenteral nutrition therapy.
- Hypersensitivity or allergy to zinc or copper.
- Baseline ferritin ≥300 ng/mL or below 100 ng/mL.
- Baseline Transferrin Saturation (TSAT) ≥45% or below 20%.
- Prior or current cholestatic liver disease defined as a clinical condition associated with decrease in bile flow due to impaired secretion by hepatocytes or to obstruction of bile flow through intra-or extrahepatic bile ducts.
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 |
|---|---|---|
| TralementAlso: trace elements (zinc sulfate, cupric sulfate, manganese sulfate and selenious acid)Tralement with Manganese | Drug | Tralement |
| Fixed-dose trace element combination product of zinc, copper, and selenious acidAlso: trace elements (zinc sulfate, cupric sulfate, manganese sulfate and selenious acid)Tralement without Manganese | Drug | a fixed-dose trace element combination product of zinc, copper, and selenious acid |
Primary outcome
To assess efficacy of brain deposition of manganese in Tralement versus a fixed-dose trace element product of zinc, copper, and selenious acid.
Time frame: Six months
Change from baseline in basal ganglia index (BG-index) as determined by T1-weighted brain MRI images
2 secondary outcomes
To assess the efficacy of Tralement versus a fixed-dose trace element product of zinc, copper, and selenious acid.
Time frame: Six months
To assess the safety of Tralement versus a fixed-dose trace element product of zinc, copper, and selenious acid
Time frame: Six months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
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.
Mark Falone, MD study director
Medical Director
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tralement and Fixed-dose trace element combination product of zinc, copper, and selenious acid in people with Manganese Safety in Pediatric Patients, run by American Regent, Inc..
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 7 inclusion and 11 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: withdrawn, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess efficacy of brain deposition of manganese in Tralement versus a fixed-dose trace element product of zinc, copper, and selenious acid. (time frame: Six months). It is what the study was designed to measure, not a finding.
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 15 Nov 2024.