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Compassionate Use of Omegaven for Pediatric Patients With Parenteral Nutrition Associated Liver Disease (Omegaven)

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. Identifier: NCT01297933
Expanded Access Status : Approved for marketing
First Posted : February 17, 2011
Last Update Posted : April 12, 2019
Information provided by (Responsible Party):
Maria Mascarenhas, Children's Hospital of Philadelphia

Brief Summary:
A compassionate use protocol to provide Omegaven to pediatric patients with parenteral nutrition (PN) dependence and parenteral nutrition associated liver disease (PNALD).

Condition or disease Intervention/treatment
Cholestasis Short Bowel Syndrome Drug: Omegaven

Detailed Description:
Omegaven is an intravenous fat emulsion (IFE) comprised of omega-3 fatty acids derived from fish oil. It will be used in an open label compassionate use treatment protocol, as an alternative to soybean oil (omega-6), as the sole IFE source of parenteral nutrition in an effort to reduce and/or reverse parenteral nutrition associated liver disease. The study will evaluate the safety and efficacy of Omegaven use in pediatric patients with PN dependence and PNALD.

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Study Type : Expanded Access
Official Title: Intravenous Omega-3 Fatty Acid (Omegaven) for Pediatric Patients With Total Parenteral Nutrition Associated Liver Dysfunction

Intervention Details:
  • Drug: Omegaven
    10% Omegaven 1g/kg/day, Intravenous by continuous infusion in conjunction with parenteral nutrition, until the patient no longer requires parenteral nutrition or until participation in the study is terminated.

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • PN dependence due to congenital or acquired gastrointestinal disease
  • Predicted PN requirement for at least an additional 30 days
  • Parenteral nutrition associated liver disease (PNALD), defined as two conjugated bilirubin levels >= 2 mg/dL at least one week apart, must be obtained to demonstrate persistence of PNALD
  • Failure to respond to standard therapies which may include cycling PN, reduction in the dose of soybean derived IFE, attempts to advance enteral feeds, ursodiol, metronidazole, and avoidance of excessive caloric provision
  • signed parent or legal guardian informed consent

Exclusion Criteria:

  • Acute treatable infection (e.g. urinary tract infection, sepsis)
  • Known allergy to egg or fish protein
  • Contraindications to Omegaven
  • Pregnancy
  • Serum triglyceride level greater than 400 mg/dL at baseline
  • History of severe hemolytic disorders or INR greater than 1.5 at baseline (INR cutoff of greater than 2 for infants less than 1 week of age)

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 identifier (NCT number): NCT01297933

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United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
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Principal Investigator: Maria Mascarenhas, MBBS Children's Hospital of Philadelphia

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Responsible Party: Maria Mascarenhas, Section Chief, Clinical Nutrition, Children's Hospital of Philadelphia Identifier: NCT01297933    
Other Study ID Numbers: 10-007681
First Posted: February 17, 2011    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019
Keywords provided by Maria Mascarenhas, Children's Hospital of Philadelphia:
parenteral nutrition associated liver disease
short bowel syndrome
Additional relevant MeSH terms:
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Short Bowel Syndrome
Pathologic Processes
Digestive System Diseases
Bile Duct Diseases
Biliary Tract Diseases
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Postoperative Complications