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Efficacy and Safety of Omega-3 Lipid Therapy in Pediatric Patients With Parenteral Nutrition-Associated Liver Disease

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2012 by Amarnath, Rathna, M.D..
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01739517
First Posted: December 3, 2012
Last Update Posted: December 3, 2012
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.
Information provided by (Responsible Party):
Amarnath, Rathna, M.D.
November 28, 2012
December 3, 2012
December 3, 2012
March 2009
December 2013   (Final data collection date for primary outcome measure)
Improvement of liver dysfunction as measured by time to achieve 50 % decrease in direct bilirubin [ Time Frame: weekly then biweekly data collection ]
Direct bilirubin will be collected at baseline, then weekly for 30 days, and then biweekly, thereafter, up to an expected average of 108 weeks
Same as current
No Changes Posted
  • a) Maintenance of nutritional status [ Time Frame: Labwork will be collected at baseline, then weekly for the first month. Thereafter, a lipid panel will be collected every 2 months, complete metabolic panel every 2 weeks, and essential fatty acid profile monthly, up to an expected average of 108 weeks ]
    Nutritional status will be monitored by reviewing complete metabolic panel, magnesium, weight, vitals, phosphorus, prealbumin, lipid panel, and essential free fatty acid profile. The essential fatty acid profile will be checked at baseline and then monthly for at least 6 months until the patient is determined to be receiving at least 2.7% of caloric intake from linoleic acid. If the patient's essential fatty acid profile indicates that the patient is absorbing adequate amounts of essential fatty acid, the essential fatty acid profile will be discontinued .
  • Occurrence of potential adverse side effects [ Time Frame: biweekly labwork up to an expected average of 108 weeks ]
    Adverse events may include but are not limited to prolonged prothrombin time, hypertriglyceridemia, and anaphylaxis in relation to the patient's therapy.
  • c) Resolution of liver dysfunction [ Time Frame: weekly complete metabolic panel for the first month and then biweekly thereafter, up to an expected average of 108 weeks ]
    Resolution of liver dysfunction will be defined by achievement of normal direct bilirubin, aspartate aminotransferase and alanine transaminase.
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Omega-3 Lipid Therapy in Pediatric Patients With Parenteral Nutrition-Associated Liver Disease
Efficacy and Safety of Omega-3 Lipid Therapy in Pediatric Patients With Parenteral Nutrition-Associated Liver Disease
This pilot study seeks to demonstrate the efficacy of an intravenous lipid preparation high in omega-3 fatty acids (Omegaven) in the treatment of cholestasis in parenteral nutrition dependent patients with short gut syndrome.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Short Bowel Syndrome
  • Cholestasis
Drug: Omegaven Therapy
After baseline labs, which have been collected no earlier than seven days prior to the initiation of therapy are obtained, therapy with Omegaven will be initiated at a starting dose of 0.5 g/kg/day infused over 12 hours. If tolerated, the dose will be increased to 1 g/kg/day, the goal dose. Omegaven will be infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition.
Experimental: Omegaven Therapy
After baseline labs, which have been collected no earlier than seven days prior to the initiation of therapy are obtained, therapy with Omegaven will be initiated at a starting dose of 0.5 g/kg/day infused over 12 hours. If tolerated, the dose will be increased to 1 g/kg/day, the goal dose. Omegaven will be infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition.
Intervention: Drug: Omegaven Therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
20
December 2013
December 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient will be dependent upon parenteral nutrition (PN)
  • Patient will have short gut syndrome (loss of >50% of small bowel)
  • Patient's guardian/caregiver provides informed consent for patient to receive therapy
  • Pediatric patient ≤ 1 year of age
  • Expected PN duration is greater than 30 days
  • Direct bilirubin >2.0 mg/dL measured on two occasions no more than one week apart

Exclusion Criteria:

  • Liver dysfunction secondary to cause other than PN verified by standard of care diagnostic procedures and lab work to rule out alternative causes of neonatal cholestasis.
  • Any patient in whom Omegaven therapy would be contraindicated, such as an allergy to any seafood product, egg protein, and/or previously established allergy to Omegaven
  • impaired lipid metabolism
  • severe hemorrhagic disorder
  • unstable diabetes mellitus
  • collapse and shock, stroke/embolism, recent cardiac infarction, or undefined coma status
Sexes Eligible for Study: All
up to 1 Year   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01739517
IND104555
Yes
Not Provided
Not Provided
Amarnath, Rathna, M.D.
Amarnath, Rathna, M.D.
Not Provided
Principal Investigator: Terra R Varner, PharmD Palmetto Health Children's Hospital
Amarnath, Rathna, M.D.
November 2012

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