A Phase 3 interventional study of Omega-3 fish oil lipid emulsion in Cholestasis, sponsored by Kapiolani Medical Center For Women & Children. Completed at 1 site in United States. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2026-04-03.
Sponsored by Kapiolani Medical Center For Women & Children · Phase 3, Interventional, and Treatment
Use of a fish oil emulsion to decrease liver disease due to long term intravenous nutrition.
Unlike conventional intravenous fat emulsions, Omegaven™ is comprised solely of fish oils containing primarily omega-3 fatty acids. Animal studies have shown that IV fat emulsions such as fish oil that are high in eicosapentaenic and docosahexaenoic acids reduce impairment of bile flow as seen in cholestasis caused by conventional fat emulsions. It is thought that by administering Omegaven™ in place of conventional phytosterol/soybean fat emulsions, cholestasis may be prevented or reversed, and patients will be able to be maintained on adequate PN for growth until they are able to ingest adequate nutrition enterally. Ongoing studies are addressing safety and efficacy of Omegaven™ in the pediatric population. In this trial, infants and children with parenteral nutrition associated liver disease will receive Omegaven™ as compassionate use to potentially prevent progression of disease. Safety and efficacy are monitored.
150 studies on the registry are indexed under Cholestasis; 18 are open to participants now.
This study's enrollment of 36 is below the median of 53 across 90 interventional studies indexed under Cholestasis.
Browse Cholestasis studies →This is the only study on the registry with Kapiolani Medical Center For Women & Children as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Administration of intravenous Omega-3 fish oil lipid emulsion 1 g/kg continuous infusion over 12-24 hrs
Drug: Omega-3 fish oil lipid emulsion
daily intravenous administration of Omegaven fish oil emulsion
Also known as: Omegaven
improving cholestasis
decline in serum direct bilirubin levels below 2 cm on 2 serial measures
Time frame: One month, 2 months, 3 months after starting omegaven and 1 month after completing treatment
improving liver function tests
includes ALT, AST, GGT, and triglycerides
Time frame: 1 year
Plan to share: Undecided
Ran from Oct 2010 to primary completion in Nov 2018, 97 months.
Of 12 phase 3 interventional studies under Cholestasis, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 64. This study's 97 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Fish oil triglycerides