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

This study is currently recruiting participants.
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
History of Changes
  Purpose

Use of a fish oil emulsion to decrease liver disease due to long term intravenous nutrition.


Condition Intervention Phase
Parenteral Nutrition Associated Liver Disease
 Drug: fish oil emulsion Omega 3 fatty acid
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of Omegaven for Parenteral Nutrition Associated Liver Disease

Resource links provided by NLM:

MedlinePlus related topics: Liver Diseases
U.S. FDA Resources

Further study details as provided by Kapiolani Medical Center For Women & Children:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • improving liver function tests [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    includes ALT, AST, GGT, and triglycerides


Estimated Enrollment: 10
Study Start Date: September 2010
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Omegaven
Intravenous administration of Omegaven fish oil emulsion
 Drug: fish oil emulsion Omega 3 fatty acid
daily intravenous administration of Omegaven fish oil emulsion
Other Name: Omegaven

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01194063

Contacts
Contact: Lynn M Iwamoto, MD 808-983-6000 lynni@kapiolani.org
Contact: Sidney Johnson, MD 808-983-6210 sidney.johnson@kapiolani.org

Locations
United States, Hawaii
Kapiolani Medical Center for Women and Children Recruiting
Honolulu, Hawaii, United States, 96826
Principal Investigator: Lynn M Iwamoto, MD            
Sub-Investigator: Charles R Neal, MD PhD            
Sub-Investigator: Sidney Johnson, MD            
Sponsors and Collaborators
Kapiolani Medical Center For Women & Children
Investigators
Principal Investigator: Lynn M Iwamoto, MD Kapiolani Medical Center for Women and Children
  More Information

Publications:

Responsible Party: Lynn Iwamoto, Kapiolani Medical Center for Women and Children
ClinicalTrials.gov Identifier: NCT01194063     History of Changes
Other Study ID Numbers: 107954
Study First Received: June 17, 2010
Last Updated: June 27, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Kapiolani Medical Center For Women & Children:
short bowel syndrome
cholestasis
pediatric

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 22, 2013