Use of Omegaven Fish Oil Emulsion for Parenteral Nutrition Associated Liver Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by Kapiolani Medical Center For Women & Children
Sponsor:
Information provided by (Responsible Party):
Lynn M. Iwamoto, Kapiolani Medical Center For Women & Children
ClinicalTrials.gov Identifier:
NCT01194063
First received: June 17, 2010
Last updated: April 6, 2015
Last verified: April 2015

June 17, 2010
April 6, 2015
September 2010
August 2015   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
decline in serum direct bilirubin levels below 2 cm on 2 serial measures [ Time Frame: monthly ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01194063 on ClinicalTrials.gov Archive Site
improving liver function tests [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 2015
August 2015   (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
Both
Not Provided
No
Contact: Lynn M Iwamoto, MD 808-983-6000 lynni@kapiolani.org
Contact: Sidney Johnson, MD 808-983-6210 sidney.johnson@kapiolani.org
United States
 
NCT01194063
107954
Yes
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
April 2015

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