Clinical Trial

Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven Treatment

Recruiting
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Summary
This study will demonstrate safety in pediatric patients with Parenteral Nutrition-Associated Cholestasis treated with Omegaven®, which is indicated as a source of calories and fatty acids in this patient population
Protocol Amendment History 2 changes
notable Primary completion pushed: 2026-03-01 -> 2028-04-01 2026-08-15
minor Completion pushed: 2027-03-01 -> 2028-04-01 2026-08-15
Trial Details
NCT Number NCT06274788
Lead Sponsor Fresenius Kabi
Conditions Parenteral Nutrition Associated Liver Disease (PNALD), Essential Fatty Acid Deficiency, Malnutrition, Pediatric ALL
Enrollment 40 participants
Start Date 2024-12-15
Primary Completion 2028-04-01 (estimated)
Study Completion 2028-04-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-14