Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven Treatment
NCT ID: NCT06274788
Last Updated: 2025-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
40 participants
OBSERVATIONAL
2024-12-15
2027-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Single arm OMEGAVEN® (fish oil triglycerides; injectable emulsion)
The dose of investigational drug (study treatment), as well as all other components of the overall nutritional regimen is solely at the discretion of the Investigator. It is assumed the Investigator will use sound medical judgement, follow institutional standards of care regarding the nutrition provided to each patient, and review applicable prescribing information indicating the maximum and recommended dose of Omegaven of 1 g/kg/day infused intravenously over 8 to 24 hours as long as the infusion rate does not exceed 1.5 mL/kg/hour.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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.
1 Day
17 Years
ALL
No
Sponsors
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Fresenius Kabi
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Other Identifiers
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OMEG-054-CP4
Identifier Type: -
Identifier Source: org_study_id
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