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

Recruiting now

Conditions studied: Parenteral Nutrition Associated Liver Disease (PNALD), Essential Fatty Acid Deficiency, Malnutrition, Pediatric ALL

In brief

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

Key facts

Study ID

NCT06274788

Run by

Fresenius Kabi

People needed

40

Starts

2024-12-15

Expected to finish

2027-03-01

Last updated by the study team

2025-09-05

Who can join

Age: 0 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient's parent(s) or legal guardian(s) has provided a signed and dated Informed Consent Form (ICF).
• Pediatric patient (<18 years) has been diagnosed with PNAC, defined as direct or conjugated bilirubin (DBil) ≥ 2.0 mg/dL with no other known cause of liver dysfunction at the time of enrollment and is expected to require Omegaven treatment for at least eight weeks.
• Patient has oral or enteral feeding intolerance or at least one gastrointestinal disorder requiring PN.

You may not qualify if…

• Patient has received Omegaven within four weeks before inclusion in the study
• Patient has any other known cause of chronic liver disease such as hepatitis C, cystic fibrosis, biliary atresia, alpha-1-antitrypsin deficiency, passive hepatic congestion due to heart failure, etc.
• Patient has known cirrhosis (liver biopsy is not required under this protocol).
• Patient has been previously diagnosed with, or has prior evidence of, portal vein thrombosis.
• Patient has previously received a liver-only or liver-inclusive transplant.
• Patient has hemodynamic instability due to any major cardiac anomaly.
• Patient has a major life-threatening disease (e.g., sepsis requiring high-dose vasopressors, acute respiratory distress syndrome, veno-occlusive disease, cancer).
• Patient has multi-organ failure, septic shock, hypotension requiring pressor therapy, persistent pulmonary hypertension requiring inhaled nitric oxides, or requires extracorporeal membrane oxygenation (ECMO) or similar intervention.
• Patient has renal failure and requires renal replacement therapy.
• Patient has a severe hemorrhagic disorder.
• Patient has severe hyperlipidemia or a severe disorder of lipid metabolism characterized by hypertriglyceridemia (i.e., serum triglyceride level > 1,000 mg/dL).
• Patient has a record of EFAD before inclusion in the study
• Patient has been diagnosed with or is suspected to have an inborn error of metabolism.
• Patient has a known hypersensitivity to fish or egg protein or to any of the active ingredients or excipients of Omegaven.
• Patient is subject to treatment limitation.
• Patient is enrolled in any other study with an investigational medicinal product during the course of the current study.

Where it is running

• Seattle Children's Hospital d/b/a Seattle Children's Research Institute — Seattle, Washington, United States (enrolling)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
• Baylor College of Medicine Houston — Houston, Texas, United States (enrolling)
• Memorial Health Service — Fountain Valley, California, United States (enrolling)
• University of California Los Angeles — Los Angeles, California, United States (enrolling)
• The University of Chicago — Chicago, Illinois, United States (enrolling)
• Children's Hospital Corporation d/b/a Boston Children's Hospital — Boston, Massachusetts, United States (enrolling)
• Children's Hospital Medical Center — Cincinnati, Ohio, United States (enrolling)
• Board of Regents of the University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States (enrolling)
• The University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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