Overview

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.