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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 & 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 September 22, 2014