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

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Conditions studied: Cholestasis, Short Bowel Syndrome

In brief

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

Key facts

Study ID

NCT01297933

Run by

Children's Hospital of Philadelphia

Last updated by the study team

2019-04-12

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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