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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00969332
Recruitment Status : Terminated (study intervention was approved by the FDA)
First Posted : September 1, 2009
Results First Posted : February 12, 2020
Last Update Posted : February 26, 2020
Sponsor:
Information provided by (Responsible Party):
Kara L. Calkins, MD, University of California, Los Angeles

Brief Summary:
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 or disease Intervention/treatment Phase
Cholestasis Drug: Omegaven Phase 2

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 Vitamin E, 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 g/kg/d, will safely reverse liver disease in 80 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. 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Omegaven and Parenteral Nutrition Associated Cholestasis
Actual Study Start Date : August 2009
Actual Primary Completion Date : January 12, 2019
Actual Study Completion Date : February 12, 2019

Arm Intervention/treatment
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 g/kg/d intravenous every day for 2 days, then 1 g/kg/d intravenous everyday




Primary Outcome Measures :
  1. Time to Reversal of Parenteral Nutrition Associated Cholestasis [ Time Frame: 24 weeks, death, transplant, or discontinuation of Parenteral Nutrition (whichever comes first) ]
    weeks


Secondary Outcome Measures :
  1. Death [ Time Frame: 24 weeks, transplant, or discontinuation of Parenteral Nutrition (whichever comes first) ]
    expiration

  2. Number of Participants Who Underwent a Transplant [ Time Frame: 24 weeks, death, or discontinuation of Parenteral Nutrition (whichever comes first) ]
    includes isolated liver or multi-visceral transplant including liver graft

  3. Time to Full Enteral Feeds [ Time Frame: 24 weeks, death, transplant, or discontinuation of Parenteral Nutrition (whichever comes first) ]
    discontinuation of parenteral nutrition

  4. Growth Z-scores [ Time Frame: 24 weeks, death, transplant, or discontinuation of Parenteral Nutrition (whichever comes first) ]

    Weight Z-scores at the end of the study. Formula used: (weight at end of study-average weight of reference population)/standard deviation of weight of reference population.

    The Z-score indicates the number of standard deviations away from the mean. A weight Z-score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. A weight Z-score </= -2 indicates an underweight or malnourished status, while a weight Z-score >/= 2 indicates an overweight or obese status.


  5. Platelet Counts at the End of the Study - Risk of Bleeding [ Time Frame: 24 weeks, death, transplant, or discontinuation of Parenteral Nutrition (whichever comes first) ]
    platelet counts at the end of the study

  6. Number of Participants With Essential Fatty Acid Deficiency [ Time Frame: 24 weeks, death, transplant, or discontinuation of Parenteral Nutrition (whichever comes first) ]
    triene:tetraene ratio less than 0.2

  7. Markers of Inflammation [ Time Frame: 24 weeks, death, or discontinuation of Parenteral Nutrition (whichever comes first) ]
    Serum Cytokines - interleukin-8

  8. Markers of Sterol Metabolism [ Time Frame: 24 weeks, death, or discontinuation of Parenteral Nutrition (whichever comes first) ]
    Serum Phytosterols - stigmasterol

  9. Markers of Bile Acid Metabolism [ Time Frame: 24 weeks, death, or discontinuation of Parenteral Nutrition (whichever comes first) ]
    Serum Bile acids - total chenodeoxycholic acid

  10. Markers of Fatty Acid Metabolism [ Time Frame: 24 weeks, death, or discontinuation of Parenteral Nutrition (whichever comes first) ]
    Erythrocyte fatty acid - Docosahexaenoic Acid



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
  • Hemorrhagic disorder
  • 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 be weaned from parenteral nutrition in 30 days
  • unable to tolerate necessary monitoring
  • Patient requiring aspirin or toradel or motrin
  • Patient requiring dialysis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00969332


Locations
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United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: Kara L Calkins, MD University of California, Los Angeles
  Study Documents (Full-Text)

Documents provided by Kara L. Calkins, MD, University of California, Los Angeles:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kara L. Calkins, MD, Assistant Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00969332    
Other Study ID Numbers: 09-02-079-02
First Posted: September 1, 2009    Key Record Dates
Results First Posted: February 12, 2020
Last Update Posted: February 26, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kara L. Calkins, MD, University of California, Los Angeles:
liver
parenteral nutrition
fish oil
omegaven
children
Additional relevant MeSH terms:
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Cholestasis
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases