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

NCT06274788 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2025-09-05

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Fresenius Kabi

    lead INDUSTRY

Eligibility

Min Age
1 Day
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-15
Primary Completion
2026-03-01
Completion
2027-03-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06274788 on ClinicalTrials.gov