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
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 1 day
Maximum Age: 17
Healthy Volunteers: f
View:
• Patient's parent(s) or legal guardian(s) has provided a signed and dated Informed Consent Form (ICF).
• 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.
• Patient has oral or enteral feeding intolerance or at least one gastrointestinal disorder requiring PN.
Locations
United States
California
Memorial Health Service
RECRUITING
Fountain Valley
University of California Los Angeles
RECRUITING
Los Angeles
Illinois
The University of Chicago
RECRUITING
Chicago
Massachusetts
Children's Hospital Corporation d/b/a Boston Children's Hospital
RECRUITING
Boston
Ohio
Children's Hospital Medical Center
RECRUITING
Cincinnati
Oklahoma
Board of Regents of the University of Oklahoma Health Sciences Center
RECRUITING
Oklahoma City
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Texas
Baylor College of Medicine Houston
RECRUITING
Houston
The University of Texas Health Science Center at San Antonio
RECRUITING
San Antonio
Washington
Seattle Children's Hospital d/b/a Seattle Children's Research Institute
RECRUITING
Seattle
Contact Information
Primary
Niess Ulf, PhD
ulf.niess@fresenius-kabi.com
M +49 173 5439924
Backup
Lohse Jean-Marc, PhD
Jean-Marc.Lohse@fresenius-kabi.com
+49 173 5420453
Time Frame
Start Date: 2024-12-15
Estimated Completion Date: 2027-03-01
Participants
Target number of participants: 40
Treatments
Single arm OMEGAVEN® (fish oil triglycerides; injectable emulsion)
The dose of investigational drug (study treatment), as well as all other components of the overall nutritional regimen is solely at the discretion of the Investigator. It is assumed the Investigator will use sound medical judgement, follow institutional standards of care regarding the nutrition provided to each patient, and review applicable prescribing information indicating the maximum and recommended dose of Omegaven of 1 g/kg/day infused intravenously over 8 to 24 hours as long as the infusion rate does not exceed 1.5 mL/kg/hour.
Related Therapeutic Areas
Sponsors
Leads: Fresenius Kabi