Tralement Versus a Fixed-dose Trace Element Combination Product of Zinc, Copper, and Selenious Acid to Evaluate Product Safety in Adult Patients 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 adult patients requiring long-term parenteral nutrition.

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

Details

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

Criteria

Inclusion Criteria:

• Adult (≥18 to ≤80 years of age) participants able to provide informed consent.

• 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).

• Definitive contraception for females of reproductive age.

Exclusion Criteria:

• Prior parenteral nutrition therapy.

• Hypersensitivity or allergy to zinc or copper.

• History of occupational exposure to manganese and documented by laboratory test results.

• 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.