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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2011 by Kapiolani Medical Center For Women & Children
Sponsor:
Information provided by:
Kapiolani Medical Center For Women & Children
ClinicalTrials.gov Identifier:
NCT01194063
First received: June 17, 2010
Last updated: June 27, 2011
Last verified: June 2011

June 17, 2010
June 27, 2011
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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Parenteral Nutrition Associated Liver Disease
Drug: fish oil emulsion Omega 3 fatty acid
daily intravenous administration of Omegaven fish oil emulsion
Other Name: Omegaven
Experimental: Omegaven
Intravenous administration of Omegaven fish oil emulsion
Intervention: Drug: fish oil emulsion Omega 3 fatty acid

*   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 Iwamoto, Kapiolani Medical Center for Women and Children
Kapiolani Medical Center For Women & Children
Not Provided
Principal Investigator: Lynn M Iwamoto, MD Kapiolani Medical Center for Women and Children
Kapiolani Medical Center For Women & Children
June 2011

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