Title: A Single-arm, Open-label, Prospective, Multicenter Safety Study to Evaluate the Occurrence of Essential Fatty Acid Deficiency (EFAD) in Pediatric Patients With Parenteral Nutrition-associated Cholestasis (PNAC) Who Require More Than Eight Weeks of Omegaven Treatment

Fresenius Kabi

Summary

This study will demonstrate safety in pediatric patients with Parenteral Nutrition-Associated Cholestasis treated with Omegaven®, which is indicated as a source of calories and fatty acids in this patient population

Eligibility

Age range: 0–17 years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: 1. Patient's parent(s) or legal guardian(s) has provided a signed and dated Informed Consent Form (ICF). 2. Pediatric patient (\<18 years) has been diagnosed with PNAC, defined as direct or conjugated bilirubin (DBil) ≥ 2.0 mg/dL with no other known cause of liver dysfunction at the time of enrollment and is expected to require Omegaven treatment for at least eight weeks. 3. Patient has oral or enteral feeding intolerance or at least one gastrointestinal disorder requiring PN. Exclusion Criteria: 1. Patient has received Omegaven within four weeks before inclusion in the…

Interventions

Drug
Omegaven® (fish oil triglycerides) Injectable Emulsion
Pediatric patients Pediatric patients with new-onset PNAC Drug: Omegaven® (fish oil triglycerides) Injectable Emulsion Dose, frequency and duration is a decision of the Investigator

Locations (10)

Memorial Health Service
Fountain Valley, California
University of California Los Angeles
Los Angeles, California
The University of Chicago
Chicago, Illinois
Children's Hospital Corporation d/b/a Boston Children's Hospital
Boston, Massachusetts
Children's Hospital Medical Center
Cincinnati, Ohio
Board of Regents of the University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma