RecruitingNCT06274788

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


Sponsor

Fresenius Kabi

Enrollment

40 participants

Start Date

Dec 15, 2024

Study Type

OBSERVATIONAL

Conditions

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


Eligibility

Min Age: 1 DayMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study is monitoring whether children receiving a fish oil-based IV nutrition supplement called Omegaven for more than 8 weeks develop a condition called essential fatty acid deficiency (EFAD). These children have liver disease related to IV nutrition (called PNAC) and cannot tolerate regular feeding. **You may be eligible if...** - Your child is under 18 years old - Your child has been diagnosed with PNAC (liver injury from IV nutrition), shown by elevated liver bilirubin levels - Your child cannot tolerate oral or tube feeding and needs IV nutrition - Your child is expected to need Omegaven treatment for at least 8 weeks **You may NOT be eligible if...** - Your child received Omegaven within the past 4 weeks - Your child has another known cause of chronic liver disease (e.g., hepatitis C, cystic fibrosis, biliary atresia) - Your child has cirrhosis, a blood clot in the portal vein, or has had a liver transplant - Your child has major heart problems, multi-organ failure, or a life-threatening illness like sepsis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOmegaven® (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


Locations(10)

Memorial Health Service

Fountain Valley, California, United States

University of California Los Angeles

Los Angeles, California, United States

The University of Chicago

Chicago, Illinois, United States

Children's Hospital Corporation d/b/a Boston Children's Hospital

Boston, Massachusetts, United States

Children's Hospital Medical Center

Cincinnati, Ohio, United States

Board of Regents of the University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Baylor College of Medicine Houston

Houston, Texas, United States

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Seattle Children's Hospital d/b/a Seattle Children's Research Institute

Seattle, Washington, United States

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NCT06274788


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