Tralement vs. Fixed-dose Trace Element Combination Product in Patients >3 to 17 Years of Age Requiring Long-term PN

NCT05677126 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: TE20002
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Manganese Safety in Pediatric Patients

Outcome Measures

Primary Outcomes (1)

• 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

  Six months

Secondary Outcomes (2)

• To assess the efficacy of Tralement versus a fixed-dose trace element product of zinc, copper, and selenious acid.

  Six months

• To assess the safety of Tralement versus a fixed-dose trace element product of zinc, copper, and selenious acid

  Six months

Other Outcomes (2)

• To assess efficacy of Tralement versus a fixed-dose trace element product of zinc, copper, and selenious acid for the subset of participants who are eligible to, and consent to, the extension study.

  12 months

• To assess the safety of Tralement versus a fixed-dose trace element product of zinc, copper, and selenious acid for the subset of participants who are eligible to, and consent to, the extension study.

  12 months

Study Arms (2)

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.

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.

Drug: Fixed-dose trace element combination product of zinc, copper, and selenious acid

Interventions

Tralement DRUG

Tralement with Manganese

Also known as: trace elements (zinc sulfate, cupric sulfate, manganese sulfate and selenious acid)

Tralement

Fixed-dose trace element combination product of zinc, copper, and selenious acid DRUG

Tralement without Manganese

Also known as: trace elements (zinc sulfate, cupric sulfate, manganese sulfate and selenious acid)

a fixed-dose trace element combination product of zinc, copper, and selenious acid

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• American Regent, Inc.: lead

MeSH Terms

Interventions

Trace Elements; Zinc Sulfate; Copper Sulfate; manganese sulfate; Selenious Acid; Copper

Intervention Hierarchy (Ancestors)

Elements; Inorganic Chemicals; Micronutrients; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Nutrients; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Zinc Compounds; Selenium Compounds; Metals, Heavy; Transition Elements; Metals

Study Officials

• Mark Falone, MD

  Medical Director

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: January 10, 2023
• Study Start: August 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: August 26, 2024
• Last Updated: November 15, 2024

Record last verified: 2024-08