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

• Status: Not yet recruiting
• Trial end date: 2026-12-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: American Regent, Inc.
• Treatments: Copper; Micronutrients; Selenious Acid; Trace Elements

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

• 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.