Compassionate Use of Omegaven for Pediatric Patients With Parenteral Nutrition Associated Liver Disease (Omegaven)
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ClinicalTrials.gov Identifier: NCT01297933
Expanded Access Status :
Approved for marketing
First Posted : February 17, 2011
Last Update Posted : April 12, 2019
Children's Hospital of Philadelphia
Information provided by (Responsible Party):
Maria Mascarenhas, Children's Hospital of Philadelphia
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
CholestasisShort Bowel Syndrome
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.
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.
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Layout table for eligibility information
Ages Eligible for Study:
up to 21 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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