NCT05677126

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

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: American Regent, Inc. · Industry
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	Tralement	Tralement with Manganese
DRUG	Fixed-dose trace element combination product of zinc, copper, and selenious acid	Tralement without Manganese

Timeline

• Start date: 2024-08-01
• Primary completion: 2024-08-01
• Completion: 2024-08-26
• First posted: 2023-01-10
• Last updated: 2024-11-15

Regulatory

• FDA-regulated drug study