CholestasisPhase 3NCT01194063
Use of Omegaven Fish Oil Emulsion for Parenteral Nutrition Associated Liver Disease in Infants and Children
A Phase 3 study testing Omega-3 fish oil lipid emulsion in people with Cholestasis, run by Kapiolani Medical Center For Women & Children at 1 site in United States.
Trial summary
Use of a fish oil emulsion to decrease liver disease due to long term intravenous nutrition. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Cholestasis
- What is being tested?
- Omega-3 fish oil lipid emulsion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2010to 15 Jan 2019
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- direct bilirubin > 2 mg/dl x2 consecutive
- parenteral nutrition dependent, expected to continue for at least another 30 days from the first day
- patient must have utilized standard therapies to prevent the progression of liver disease
Who cannot join
- other primary cause of liver disease not parenteral nutrition-associated
- weight <3 kg
- infant or child enrolled in other clinical trial involving an investigational agent
Trial locations and contacts
1 site in 1 country.
United States1 site
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
About this study
Official title: Use of Omegaven for Parenteral Nutrition Associated Liver Disease
Use of a fish oil emulsion to decrease liver disease due to long term intravenous nutrition.
Read the detailed description
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.
- Conditions
- Cholestasis
- Being tested
- Omega-3 fish oil lipid emulsion
- Keywords
- short bowel syndrome, parenteral nutrition associated liver disease, pediatric
- Medical subject headings
- Cholestasis, Short Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 fish oil lipid emulsionDrug
Also called Omegaven
daily intravenous administration of Omegaven fish oil emulsion
| Study group | Role | What they receive |
|---|---|---|
| Omegaven | Experimental | Administration of intravenous Omega-3 fish oil lipid emulsion 1 g/kg continuous infusion over 12-24 hrs Receives: Drug: Omega-3 fish oil lipid emulsion |
What is being measured
The primary outcome is the main question the study is designed to answer.
improving cholestasis
decline in serum direct bilirubin levels below 2 cm on 2 serial measures
Measured: One month, 2 months, 3 months after starting omegaven and 1 month after completing treatment
Secondary outcomes (1)
improving liver function tests
includes ALT, AST, GGT, and triglycerides
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2010 (estimated)
- Study start20 Oct 2010
- Primary completion30 Nov 2018
- Study completion15 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CholestasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kapiolani Medical Center For Women & Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lynn M. Iwamoto, Kapiolani Medical Center For Women & Children
- Investigators
- Lynn M Iwamoto, MD, Principal investigator, Kapiolani Medical Center For Women & Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01194063
- Sponsor's protocol ID
- 107954
- Status last verified
- Mar 2026
- First submitted
- 17 Jun 2010
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lee SI, Valim C, Johnston P, Le HD, Meisel J, Arsenault DA, Gura KM, Puder M. Impact of fish oil-based lipid emulsion on serum triglyceride, bilirubin, and albumin levels in children with parenteral nutrition-associated liver disease. Pediatr Res. 2009 Dec;66(6):698-703. doi: 10.1203/PDR.0b013e3181bbdf2b.
PubMed 19687773de Meijer VE, Le HD, Meisel JA, Gura KM, Puder M. Parenteral fish oil as monotherapy prevents essential fatty acid deficiency in parenteral nutrition-dependent patients. J Pediatr Gastroenterol Nutr. 2010 Feb;50(2):212-8. doi: 10.1097/MPG.0b013e3181bbf51e.
PubMed 20038849