Fish oil treatment tested for kids with liver damage from IV nutrition
NCT ID NCT06274788
First seen Jun 25, 2026 · Last updated Aug 14, 2026 · Updated 2 times
Summary
This study is testing the safety of Omegaven, a fish oil-based fat emulsion, in 40 children under 18 who have developed liver problems (cholestasis) from long-term IV nutrition. The main goal is to see how many children develop essential fatty acid deficiency during at least 8 weeks of treatment. Researchers will also watch for symptoms like dry skin, hair loss, and poor growth.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Omegaven (fish oil triglycerides) injectable emulsion
- What this could lead to
- If successful, this could show that Omegaven is a safe way to provide essential fats and calories to children with liver problems caused by IV nutrition.
- What could go wrong
- This is a small, early-phase safety study with only 40 participants. It may not prove effectiveness, and some children might still develop fatty acid deficiency or other side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Male and female pediatric patients with PNAC and expected requirement of Omegaven for at least 8 weeks will be enrolled at multiple sites; PNAC is defined as being PN-dependent with a DBil level ≥ 2.0 mg/dL and no other known cause of liver dysfunction.
- Ages
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1 day to 17 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
10 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Baylor College of Medicine Houston
RECRUITINGHouston, Texas, 77030, United States
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Board of Regents of the University of Oklahoma Health Sciences Center
RECRUITINGOklahoma City, Oklahoma, 73104, United States
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Children's Hospital Corporation d/b/a Boston Children's Hospital
RECRUITINGBoston, Massachusetts, 02115, United States
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Children's Hospital Medical Center
RECRUITINGCincinnati, Ohio, 45229, United States
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Memorial Health Service
RECRUITINGFountain Valley, California, 92708, United States
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Seattle Children's Hospital d/b/a Seattle Children's Research Institute
RECRUITINGSeattle, Washington, 98105, United States
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The University of Chicago
RECRUITINGChicago, Illinois, 60637, United States
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The University of Texas Health Science Center at San Antonio
RECRUITINGSan Antonio, Texas, 78229-3901, United States
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University of California Los Angeles
RECRUITINGLos Angeles, California, 10911, United States
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Vanderbilt University Medical Center
RECRUITINGNashville, Tennessee, 37232, United States
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