Evaluating the safety of Omegaven in children with liver disease from parenteral nutrition

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the safety of Omegaven®, a fish oil triglyceride injectable emulsion, in pediatric patients diagnosed with Parenteral Nutrition-Associated Cholestasis (PNAC). The study will include children under 18 years who require Omegaven treatment for more than eight weeks due to malnutrition or gastrointestinal disorders. Participants will be monitored for the occurrence of essential fatty acid deficiency (EFAD) during their treatment. The study will gather data to ensure the safety of this treatment approach in a vulnerable pediatric population.

Why it matters

Who can join: the full rules

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 study
2. Patient has any other known cause of chronic liver disease such as hepatitis C, cystic fibrosis, biliary atresia, alpha-1-antitrypsin deficiency, passive hepatic congestion due to heart failure, etc.
3. Patient has known cirrhosis (liver biopsy is not required under this protocol).
4. Patient has been previously diagnosed with, or has prior evidence of, portal vein thrombosis.
5. Patient has previously received a liver-only or liver-inclusive transplant.
6. Patient has hemodynamic instability due to any major cardiac anomaly.
7. Patient has a major life-threatening disease (e.g., sepsis requiring high-dose vasopressors, acute respiratory distress syndrome, veno-occlusive disease, cancer).
8. Patient has multi-organ failure, septic shock, hypotension requiring pressor therapy, persistent pulmonary hypertension requiring inhaled nitric oxides, or requires extracorporeal membrane oxygenation (ECMO) or similar intervention.
9. Patient has renal failure and requires renal replacement therapy.
10. Patient has a severe hemorrhagic disorder.
11. Patient has severe hyperlipidemia or a severe disorder of lipid metabolism characterized by hypertriglyceridemia (i.e., serum triglyceride level \> 1,000 mg/dL).
12. Patient has a record of EFAD before inclusion in the study
13. Patient has been diagnosed with or is suspected to have an inborn error of metabolism.
14. Patient has a known hypersensitivity to fish or egg protein or to any of the active ingredients or excipients of Omegaven.
15. Patient is subject to treatment limitation.
16. Patient is enrolled in any other study with an investigational medicinal product during the course of the current study.

Where it's running

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

Study contacts

• Study coordinator: Niess Ulf, PhD
• Email: ulf.niess@fresenius-kabi.com
• Phone: M +49 173 5439924

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.