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

Expanded access is currently available for this treatment.
Verified July 2014 by Children's Hospital of Philadelphia
Sponsor:
Information provided by (Responsible Party):
Maria Mascarenhas, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT01297933
First received: February 15, 2011
Last updated: July 30, 2014
Last verified: July 2014

February 15, 2011
July 30, 2014
January 2011
January 2017   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01297933 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Compassionate Use of Omegaven for Pediatric Patients With Parenteral Nutrition Associated Liver Disease
Intravenous Omega-3 Fatty Acid (Omegaven) for Pediatric Patients With Total Parenteral Nutrition Associated Liver Dysfunction

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

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.

Expanded Access
Phase 1
Not Provided
  • Cholestasis
  • Short Bowel Syndrome
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Available
Not Provided
January 2017
January 2017   (final data collection date for primary outcome measure)

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 a conjugated bilirubin >= 2 mg/dL
  • 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:

  • Other known causes of chronic liver disease (i.e. infectious hepatitis, metabolic disease)
  • 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)
Both
up to 21 Years
No
Contact: Maria Mascarenhas, MBBS 215-590-2997 mascarenhas@email.chop.edu
Contact: Debbie Kawchak 267-426-7576 kawchak@email.chop.edu
United States
 
NCT01297933
10-007681
No
Maria Mascarenhas, Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
Not Provided
Principal Investigator: Maria Mascarenhas, MBBS Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
July 2014

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