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

• Status: Approved for marketing
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital of Philadelphia

Criteria

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)