Safety Study of Omegaven® in Children with Liver Disease
This study is looking at the safety of Omegaven® (fish oil triglycerides) Injectable Emulsion in children who have Parenteral Nutrition-Associated Cholestasis (PNAC), a type of liver disease. Omegaven® is already used to provide calories and fatty acids to these patients. Researchers want to see how often essential fatty acid deficiency (EFAD) occurs in children who need Omegaven® for more than eight weeks. You might be able to join if you are a child under 18 with PNAC, defined as having a direct or conjugated bilirubin level of 2.0 mg/dL or higher, and are expected to need Omegaven® treatment for at least eight weeks. The study plans to enroll 40 children. The current recruitment status is unclear.
- Study design
- This is an observational study, meaning researchers will watch and collect information without assigning treatments. It plans to include 40 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure essential fatty acid deficiency for up to 56 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven Treatment
At a glance
Conditions
Where it's being run
10 sites across 8 statesWho to contact
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What this trial measures
- Incidence of essential fatty acid deficiency (EFAD)Up to week 56
EFAD as defined by the triene:tetraene (T:T) ratio; severity of EFAD will be graded and analysed based on T:T ratio (suspected ≥ 0.05, moderate ≥ 0.20, and severe ≥ 0.40)