clinical trial · NCT06049680
Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients
Fresenius Kabi·phase4·recruiting·n = 100
Malnutrition, ChildMalnutritionEssential Fatty Acid Deficiency (EFAD)Parenteral Nutrition Associated CholestasisSMOFlipid® (lipid injectable emulsion)
brief summary
Evaluate the risk of developing EFAD and/or PNAC in adult and pediatric patients 1 month of age and older, who are anticipated to need 8 weeks or longer of parenteral nutrition treatment with SMOFlipid.
started
Oct 28, 2024
primary completion
Mar 1, 2026
completion
Sep 1, 2026
last updated
Dec 4, 2025
official title
A Single-arm Open-label Safety Study of SMOFlipid to Evaluate the Risk of Developing Essential Fatty Acid Deficiency (EFAD) and/or Parenteral Nutrition-associated Cholestasis (PNAC) in Pediatric Patients 1 Month to 17 Years of Age and in Adult Patients, Who Are Anticipated to Need 8 Weeks or Longer of Parenteral Nutrition Treatment
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol