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Clinical Trials in the USA / NCT06274788
Recruiting Observational

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

NCT06274788 · tracked via the Priya Life Science USA tracker
Sponsor
Fresenius Kabi
Phase
Observational
Started
2024-12-15
Last updated
2026-08-14

Condition(s) studied

Parenteral Nutrition Associated Liver Disease (PNALD)Essential Fatty Acid DeficiencyMalnutritionPediatric ALL

Investigational drug(s) / intervention(s)

Omegaven® (fish oil triglycerides) Injectable Emulsion

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

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

Eligibility

Sex
ALL
Min age
1 Day
Max age
17 Years
Healthy volunteers
No
Inclusion Criteria: 1. Patient's parent(s) or legal guardian(s) has provided a signed and dated Informed Consent Form (ICF). 2. 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. 3. Patient has oral or enteral feeding intolerance or at least one gastrointestinal disorder requiring PN. Exclusion Criteria: 1. Patient has received Omegaven within four weeks before inclusion in the study 2. 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. 3. Patient has known cirrhosis (liver biopsy is not required under this protocol). 4. Patient has been previously diagnosed with, or has prior evidence of, portal vein thrombosis. 5. Patient has previously received a liver-only or liver-inclusive transplant. 6. Patient has hemodynamic instability due to any major cardiac anomaly. 7. Patient has a major life-threatening disease (e.g., sepsis requiring high-dose vasopressors, acute respiratory distress syndrome, veno-occlusive disease, cancer). 8. 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. 9. Patient has renal failure and requires renal replacement therapy. 10. Patient has a severe hemorrhagic disorder. 11. Patient has severe hyperlipidemia or a severe disorder of lipid metabolism characterized by hypertriglyceridemia (i.e., serum triglyceride level \> 1,000 mg/dL). 12. Patient has a record of EFAD before inclusion in the study 13. Patient has been diagnosed with or is suspected to have an inborn error of metabolism. 14. Patient has a known hypersensitivity to fish or egg protein or to any of the active ingredients or excipients of Omegaven. 15. Patient is subject to treatment limitation. 16. Patient is enrolled in any other study with an investigational medicinal product during the course of the current study.

Primary outcome measure(s)

Trial sites (10)

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

More Fresenius Kabi trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06274788 on ClinicalTrials.gov ↗ ← All trials in the USA