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

Launched by AMERICAN REGENT, INC. · Dec 20, 2022

Keywords

ClinConnect Summary

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 adult 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 inpatien...

Gender

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Eligibility 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.