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Use of Omegaven Fish Oil Emulsion for Parenteral Nutrition Associated Liver Disease in Infants and Children

This study is currently recruiting participants.
Verified September 2017 by Lynn M. Iwamoto, Kapiolani Medical Center For Women & Children
Sponsor:
ClinicalTrials.gov Identifier:
NCT01194063
First Posted: September 2, 2010
Last Update Posted: September 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Lynn M. Iwamoto, Kapiolani Medical Center For Women & Children
June 17, 2010
September 2, 2010
September 25, 2017
September 2010
August 2020   (Final data collection date for primary outcome measure)
improving cholestasis [ Time Frame: One month, 2 months, 3 months after starting omegaven and 1 month after completing treatment ]
decline in serum direct bilirubin levels below 2 cm on 2 serial measures
decline in serum direct bilirubin levels below 2 cm on 2 serial measures [ Time Frame: monthly ]
Complete list of historical versions of study NCT01194063 on ClinicalTrials.gov Archive Site
improving liver function tests [ Time Frame: 1 year ]
includes ALT, AST, GGT, and triglycerides
Same as current
Not Provided
Not Provided
 
Use of Omegaven Fish Oil Emulsion for Parenteral Nutrition Associated Liver Disease in Infants and Children
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.
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.
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Cholestasis
Drug: Omega-3 fish oil lipid emulsion
daily intravenous administration of Omegaven fish oil emulsion
Other Name: Omegaven
Experimental: Omegaven
Administration of intravenous Omega-3 fish oil lipid emulsion 1 g/kg continuous infusion over 12-24 hrs
Intervention: Drug: Omega-3 fish oil lipid emulsion

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
August 2025
August 2020   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sexes Eligible for Study: All
up to 18 Years   (Child, Adult)
No
Contact: Lynn M Iwamoto, MD 808-983-8670 lynni@kapiolani.org
Contact: Charles Neal, MD PhD 808-983-8670 cneal@kapiolani.org
United States
 
 
NCT01194063
107954
Yes
Not Provided
Plan to Share IPD: Undecided
Lynn M. Iwamoto, Kapiolani Medical Center For Women & Children
Kapiolani Medical Center For Women & Children
Not Provided
Principal Investigator: Lynn M Iwamoto, MD Kapiolani Medical Center For Women & Children
Kapiolani Medical Center For Women & Children
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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