Actively Recruiting
Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven Treatment
Led by Fresenius Kabi · Updated on 2025-09-05
40
Participants Needed
10
Research Sites
115 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Parent or legal guardian has signed informed consent
- Pediatric patient under 18 years diagnosed with PNAC with direct or conjugated bilirubin 2.0 mg/dL and expected to need Omegaven treatment for at least eight weeks
- Patient has oral or enteral feeding intolerance or a gastrointestinal disorder requiring parenteral nutrition
You will not qualify if you...
- Omegaven use within four weeks before study
- Other known chronic liver diseases (hepatitis C, cystic fibrosis, biliary atresia, alpha-1-antitrypsin deficiency, passive hepatic congestion)
- Known cirrhosis
- Previous or current portal vein thrombosis
- Prior liver transplant
- Hemodynamic instability due to major cardiac anomaly
- Major life-threatening diseases (e.g., sepsis with high-dose vasopressors, ARDS, veno-occlusive disease, cancer)
- Multi-organ failure, septic shock, hypotension needing pressors, persistent pulmonary hypertension requiring inhaled nitric oxides, or ECMO
- Renal failure requiring replacement therapy
- Severe hemorrhagic disorder
- Severe hyperlipidemia or severe lipid metabolism disorder with triglycerides > 1000 mg/dL
- History of essential fatty acid deficiency before study
- Diagnosed or suspected inborn error of metabolism
- Known allergy to fish, egg protein, or Omegaven ingredients
- Subject to treatment limitation
- Enrolled in another investigational drug study during this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Memorial Health Service
Fountain Valley, California, United States, 92708
Actively Recruiting
2
University of California Los Angeles
Los Angeles, California, United States, 10911
Actively Recruiting
3
The University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
4
Children's Hospital Corporation d/b/a Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
5
Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
6
Board of Regents of the University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
7
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
8
Baylor College of Medicine Houston
Houston, Texas, United States, 77030
Actively Recruiting
9
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229-3901
Actively Recruiting
10
Seattle Children's Hospital d/b/a Seattle Children's Research Institute
Seattle, Washington, United States, 98105
Actively Recruiting
Research Team
N
Niess Ulf, PhD
CONTACT
L
Lohse Jean-Marc, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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