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

NCT04807478 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2022-08-04

No results posted yet for this study

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

Conditions

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

Interventions

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
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2028-05-01
Completion
2029-05-01
FDA Drug
Yes

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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 NCT04807478 on ClinicalTrials.gov