NCT04807478

Safety of Omegaven in Pediatric Patients With Parenteral Nutrition-Associated Cholestasis (PNAC)

A Multicenter, Prospective, Controlled, Longitudinal-Cohort Study Assessing the Safety of Omegaven in Pediatric Patients With Parenteral Nutrition-Associated Cholestasis (PNAC)

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Fresenius Kabi · Industry
• Sex: All
• Age: 1 Day
• Healthy volunteers: Not accepted

Summary

This study will demonstrate Short-, mid-, and long-term 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

Detailed description

Prospective, controlled, longitudinal-cohort phase IV study to assess safety of Omegaven in Pediatric Patients with PNAC, in order to demonstrate short-, mid-, and long-term safety with respect to EFAD, serious bleeding events, life-threatening pleural and pericardial effusions, and neurocognitive development. Pediatric patients with PNAC receiving Omegaven as part of their routine nutritional management will be compared to those treated with another FDA-approved ILE for pediatric patients. Patients who are switched to a non-FDA-approved ILE or to Omegaven will be analyzed separately. Use of ILE will be as indicated by their treating physician, ideally for ≥ 1 year. Dosing modalities are to be taken from the pertinent prescribing information.

Conditions

• Parenteral Nutrition Associated Liver Disease
• Essential Fatty Acid Deficiency
• Neurocognitive Deficit
• Malnutrition
• Pediatric ALL

Interventions

Type	Name	Description
DRUG	Omegaven® (fish oil triglycerides) Injectable Emulsion	Dose, frequency and duration is a decision of the Investigator

Timeline

• Start date: 2022-04-01
• Primary completion: 2028-05-01
• Completion: 2029-05-01
• First posted: 2021-03-19
• Last updated: 2022-08-04

Regulatory

• FDA-regulated drug study