Trial Search Results

Safety of Omegaven in Pediatric Patients With Parenteral Nutrition-Associated Cholestasis (PNAC)

This study will demonstrate Short-, mid-, and long-term 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

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Fresenius Kabi

Stanford Investigator(s):

Intervention(s):

  • Drug: Omegaven® (fish oil triglycerides) Injectable Emulsion

Eligibility


Inclusion Criteria:

   1. Patient's parent(s) or legal guardian(s) has provided a signed and dated Informed
   Consent Form (ICF).

   2. Patient is PN-dependent and within the past 21 days 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.

   3. Patient has feeding intolerance or at least one gastrointestinal disorder requiring
   PN.

   4. Patient is < 6 months corrected age (expected time of delivery to time of screening).

Exclusion Criteria:

   1. 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.

   2. Patient has known cirrhosis (liver biopsy is not required under this protocol).

   3. Patient has known portal vein thrombosis (imaging studies are not required under this
   protocol).

   4. Patient has previously received a liver-only or liver-inclusive transplant.

   5. Patient has a major cardiac anomaly with hemodynamic instability.

   6. Patient has a major life-threatening disease (e.g., sepsis requiring high-dose
   vasopressors, acute respiratory distress syndrome, veno-occlusive disease, cancer).

   7. 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.

   8. Patient has renal failure and requires dialysis.

   9. Patient has a severe hemorrhagic disorder.

10. Patient has an INR > 2.0.

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 a previous T:T ratio ≥ 0.2 or had a previous diagnosis of
   EFAD.

13. Patient has a central nervous system anomaly (e.g., anencephaly) or any injury (e.g.,
   grade 3 or 4 intraventricular hemorrhage, moderate to severe hypoxic ischemic
   encephalopathy) that will affect neurodevelopment.

14. Patient has been diagnosed with or is suspected to have a genetic disorder known to be
   associated with neurodevelopmental impairment (e.g., trisomy 21, 18, 13).

15. Patient has been diagnosed with or is suspected to have an inborn error of metabolism.

16. Patient has a known hypersensitivity to fish or egg protein or to any of the active
   ingredients or excipients of Omegaven.

17. Patient's medical care has been deemed futile by the medical team.

18. Patient is enrolled in any other study with an investigational medicinal product.

Ages Eligible for Study

1 Day - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting