Clinical Trial

Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients

Recruiting Phase 4
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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.
Protocol Amendment History 11 amendments
This ClinicalTrials.gov record has been amended 11 times since 2023-09-19; most recent amendment 2026-07-16.
Status change: Not Yet Recruiting → Recruiting 2024-11-21
Trial Details
NCT Number NCT06049680
Lead Sponsor Fresenius Kabi
Conditions Malnutrition, Child, Malnutrition, Essential Fatty Acid Deficiency (EFAD), Parenteral Nutrition Associated Cholestasis
Enrollment 100 participants
Start Date 2024-10-28
Primary Completion 2026-08 (estimated)
Study Completion 2026-09 (estimated)
Updated on ClinicalTrials.gov 2026-07-17