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Compassionate Use of Omegaven IV Fat Emulsion

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: NCT01323907
Recruitment Status : Withdrawn (Omegaven is now FDA approved.)
First Posted : March 28, 2011
Last Update Posted : February 6, 2020
Sponsor:
Information provided by (Responsible Party):
Sivan Kinberg, Columbia University

Study Description
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Brief Summary:
The purpose of the study is to provide use of Omegaven in children with life threatening Total Parenteral Nutrition (TPN) associated cholestasis when all other medical and surgical treatments/therapies have been either ineffective or not feasible in the treatment of this serious condition. This is a compassionate use protocol.

Condition or disease Intervention/treatment Phase
Total Parenteral Nutrition-induced Cholestasis Drug: Omegaven IV lipid emulsion Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Compassionate Use of Omegaven IV Fat Emulsion in Infants With Life Threatening Parenteral Nutrition-associated Liver Disease (PNALD).
Estimated Study Start Date : January 2011
Actual Primary Completion Date : February 13, 2019
Actual Study Completion Date : February 13, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: Omegaven
Omegaven IV lipid emulsion administration for infants with life threatening parenteral nutrition associated liver disease
 Drug: Omegaven IV lipid emulsion
For infants meeting inclusion criteria and whose guardians consent to participation, Omegaven will be initiated at the dose of 0.5gram/kg/day and is infused over 24 hours for 1-2 days and then advanced to 1 gram/kg/day. Omegaven will be infused intravenously through a central or peripheral catheter alone or in conjunction with parenteral nutrition.
Other Name: Omega-3 Fatty Acids


Outcome Measures
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Primary Outcome Measures :
  1. Reduction of direct serum bilirubin level (mg/dL) [ Time Frame: Up to 6 months from the completion of the study. ]
    For effectiveness endpoint, the allowable minimum time interval between serial direct bilirubin measurements that will determine reversal of cholestasis is 2 consecutive measurements of direct bilirubin < or = to 2mg/dL obtained at least 2 weeks apart.


Secondary Outcome Measures :
  1. Essential fatty acid profile [ Time Frame: Up to 30 days from therapy completion ]
    Previous studies have found no association between Omegaven administration and essential fatty acid deficiency. Due to theoretical concern for developing fatty acid deficiency with low dose Omegaven administration, these levels will be followed during Omegaven therapy.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of life threatening PNALD
  • Dependent on Parenteral Nutrition for caloric needs
  • Expected to require PN for at least another 30 days
  • Other causes of liver disease have been excluded
  • GI/Liver service is involved in patient care
  • Standard therapies for the treatment of PNALD must have been utilized prior to initiating omegaven.
  • Inpatient at Morgan Stanley Children's Hospital of NewYork Presbyterian Hospital
  • Must be at least 2 months of age

Exclusion Criteria:

  • Not inpatient
  • Younger than 2 months of age
  • Expected to be weaned off of parenteral nutrition within 30 days
  • have other documented causes of liver disease
  • have signs of proven severe advanced liver disease
  • Allergy to seafood, egg protein and/or previous allergy to Omegaven
  • active coagulopathy, impaired lipid metabolism or severe hyperlipidemia with or without pancreatitis, stoke, embolism, hemodynamic collapse or shock, recent MI, cholestasis due to any reason other than PNALD, active new infection at time of initiation of Omegaven, hemodynamic instability or if unable to tolerate the necessary laboratory monitoring
  • must not be enrolled in another clinical trial involving an investigational agent (unless approved by the designated physicians).
  • Parent or legal guardian must be willing to provide consent.
Contacts and Locations
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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): NCT01323907


Locations
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United States, New York
Columbia Presbyterian Medical Center-Children's Hospital of NY
New York, New York, United States, 10032
Sponsors and Collaborators
Sivan Kinberg
Investigators
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Principal Investigator: Sivan Kinberg, MD, MS Columbia University
More Information
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Responsible Party: Sivan Kinberg, Assistant Professor of Pediatrics at the Columbia University Medical Center, Columbia University
ClinicalTrials.gov Identifier: NCT01323907    
Other Study ID Numbers: AAAF2546
First Posted: March 28, 2011    Key Record Dates
Last Update Posted: February 6, 2020
Last Verified: February 2020
Keywords provided by Sivan Kinberg, Columbia University:
Total Parenteral Nutrition-induced Cholestasis
Omegaven
liver disease
Cholestasis
Fat emulsions
Additional relevant MeSH terms:
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Cholestasis
Digestive System Diseases
Bile Duct Diseases
Biliary Tract Diseases