NCT06274788

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

Title: A Single-arm, Open-label, Prospective, Multicenter Safety Study to Evaluate the Occurrence of Essential Fatty Acid Deficiency (EFAD) in Pediatric Patients With Parenteral Nutrition-associated Cholestasis (PNAC) Who Require More Than Eight Weeks of Omegaven Treatment

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Fresenius Kabi · Industry
• Sex: All
• Age: 1 Day – 17 Years
• Healthy volunteers: Not accepted

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

Conditions

• Parenteral Nutrition Associated Liver Disease (PNALD)
• Essential Fatty Acid Deficiency
• Malnutrition
• Pediatric ALL

Interventions

Type	Name	Description
DRUG	Omegaven® (fish oil triglycerides) Injectable Emulsion	Pediatric patients Pediatric patients with new-onset PNAC Drug: Omegaven® (fish oil triglycerides) Injectable Emulsion Dose, frequency and duration is a decision of the Investigator

Timeline

• Start date: 2024-12-15
• Primary completion: 2026-03-01
• Completion: 2027-03-01
• First posted: 2024-02-23
• Last updated: 2025-09-05

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study