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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

Status
APPROVED_FOR_MARKETING
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT01297933
Acronym
Omegaven
Enrollment
Unknown
Registered
2011-02-17
Start date
Unknown
Completion date
Unknown
Last updated
2019-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholestasis, Short Bowel Syndrome

Keywords

parenteral nutrition associated liver disease, cholestasis, short bowel syndrome, Omegaven

Brief summary

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

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.

Interventions

DRUGOmegaven

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.

Sponsors

Children's Hospital of Philadelphia
Lead SponsorOTHER

Eligibility

Sex/Gender
ALL
Age
No minimum to 21 Years
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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026