A Safety and Efficacy Study to Determine if Giving Intravenous Fish Oil Helps Children With Liver Disease (FO)

This study is currently recruiting participants. (see Contacts and Locations)

Verified December 2014 by University of California, Los Angeles

Sponsor:

Information provided by (Responsible Party):

Kara L. Calkins, MD, University of California, Los Angeles

ClinicalTrials.gov Identifier:

NCT00969332

First received: August 31, 2009

Last updated: December 1, 2014

Last verified: December 2014

History of Changes

Purpose

The purpose of the study is to investigate if intravenous fish oil, commercially available as Omegaven, safely and effectively reverses parenteral nutrition associated cholestasis in children.

Condition	Intervention	Phase
Cholestasis	Drug: Omegaven	Phase 2


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Omegaven and Parenteral Nutrition Associated Cholestasis

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:

Time to reversal of Parenteral Nutrition Associated Cholestasis [ Time Frame: 24 weeks, death, transplant, or discontinuation of Parenteral Nutrition (whichever comes first) ] [ Designated as safety issue: Yes ]
serial liver function tests

Secondary Outcome Measures:

death [ Time Frame: 24 weeks, death, transplant, or discontinuation of Parenteral Nutrition (whichever comes first) ] [ Designated as safety issue: Yes ]
transplant [ Time Frame: 24 weeks, death, transplant, or discontinuation of Parenteral Nutrition (whichever comes first) ] [ Designated as safety issue: Yes ]
time to full enteral feeds [ Time Frame: 24 weeks, death, transplant, or discontinuation of Parenteral Nutrition (whichever comes first) ] [ Designated as safety issue: No ]
growth [ Time Frame: 24 weeks, death, transplant, or discontinuation of Parenteral Nutrition (whichever comes first) ] [ Designated as safety issue: Yes ]
Z-scores
risk for bleeding [ Time Frame: 24 weeks, death, transplant, or discontinuation of Parenteral Nutrition (whichever comes first) ] [ Designated as safety issue: Yes ]
serial platelet counts and INRs


Estimated Enrollment:	40
Study Start Date:	August 2009
Estimated Study Completion Date:	August 2021
Estimated Primary Completion Date:	August 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Omegaven 0.5 g/kg/d IV x 2 days, then 1 g/kg/d IV for 24 weeks or until parenteral nutrition discontinuation, death or transplant, whichever comes first. Subjects are eligible to restart Omegaven should they re-satisfy inclusion/exclusion criteria.	Drug: Omegaven 0.5 gm/kg/d intravenous every day for 2 days, then 1 gm/kg/d intravenous everyday Other Name: Omegaven

Detailed Description:

Infants dependent on parenteral nutrition for greater than 1 year who develop Parenteral Nutrition Associated Cholestasis will universally face mortality unless they receive a timely liver and/or small bowel transplant. Although transplant survival has improved in recent years, survival is not guaranteed, and transplant care remains costly. Alternative nutritional and pharmacological strategies are imperative to improve the clinical outcomes of infants with intestinal failure and parenteral nutrition associated cholestasis. In both animal and human studies, intravenous fish oil, a lipid emulsion rich in omega-3 fatty acids and lacking phytosterols, has been shown to ameliorate parenteral nutrition associated cholestasis and improve morbidity and mortality. The purpose of this pilot study is to investigate if Omegaven, a commercially available intravenous fish oil, at 1 gm/kg/d, will safely reverse liver disease in 40 subjects with parenteral nutrition associated cholestasis. Subjects can initially receive a maximum of 6 months (24 weeks) of intravenous fish oil. If the subject re-develops liver disease and still satisfies inclusion/exclusion criteria, the intervention can be restarted up to two times for an additional 6 months (24 weeks) each time. Study subjects will be compared to a historical cohort of children with Short Bowel Syndrome and parenteral nutrition associated cholestasis who have been receiving standard intravenous soybean oil for > 60 days. The fish oil cohort will be followed for a total of 5 years to determine if transplant-free mortality is reduced.

Eligibility


Ages Eligible for Study:	up to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical evidence of Parenteral Nutrition Associated Cholestasis
Direct bilirubin greater or equal to 2 mg/dL on 2 consecutive measurements
Expected parenteral nutrition course greater than 30 days
Acquired or congenital gastrointestinal disease
> 2 weeks of age and < 18 years of age
> 60% calories from parenteral nutrition
Failed standard therapies to prevent progression of liver disease (Actigal, cyclic parenteral nutrition, avoidance of overfeeding, reduction/removal of copper from parenteral nutrition if elevated my laboratory analysis, advancement of enteral feeds)

Exclusion Criteria:

Inborn errors of metabolism
Extracorporeal Membrane Oxygenation
Seafood, egg, or Omegaven allergy
Documented case of liver disease other than Parenteral Nutrition Associated Cholestasis
Anticoagulant therapy
Hemodynamically unstable or in shock
Comatose state
Stroke, pulmonary embolism, recent myocardial infarction
Diabetes
Fatal chromosomal disorder
Enrollment in any other clinical trial involving an investigational agent
Patient, parent, or legal guardians unable or unwilling to give consent
Patient expected to weaned from parenteral nutrition in 30 days
unable to tolerate necessary monitoring

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: NCT00969332

Locations


United States, California
University of California, Los Angeles	Recruiting
Los Angeles, California, United States, 90095
Contact: Kara L Calkins, MD 310-794-9855 KCalkins@mednet.ucla.edu
Contact: Robert Venick, MD (310) 206-6134 RVenick@mednet.ucla.edu
Principal Investigator: Kara L Calkins, MD
Sub-Investigator: Stephen B Shew, MD
Sub-Investigator: James Dunn, MD, PhD
Sub-Investigator: Robert Venick, MD

Sponsors and Collaborators

University of California, Los Angeles

Investigators


Principal Investigator:	Kara L Calkins, MD	University of California, Los Angeles

More Information

No publications provided


Responsible Party:	Kara L. Calkins, MD, Clinical Assistant Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier:	NCT00969332 History of Changes
Other Study ID Numbers:	09-02-079-02
Study First Received:	August 31, 2009
Last Updated:	December 1, 2014
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of California, Los Angeles:


liver Parenteral Nutrition fish oil Omegaven children

Additional relevant MeSH terms:


Cholestasis Bile Duct Diseases Biliary Tract Diseases Digestive System Diseases

ClinicalTrials.gov processed this record on March 03, 2015

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