RecruitingParenteral Nutrition Associated Liver Disease (PNALD)Essential Fatty Acid DeficiencyMalnutrition
Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven Treatment
Eligible age
0–17 yrs
Accepts
All genders
Locations
8 states
Healthy volunteers
No
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About this study
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
Sponsor: Fresenius Kabi
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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.
Where it's recruiting
California
Fountain Valley · Los Angeles
Illinois
Chicago
Massachusetts
Boston
Ohio
Cincinnati
Oklahoma
Oklahoma City
Tennessee
Nashville
Texas
Houston · San Antonio
Washington
Seattle
Source: ClinicalTrials.gov · NCT06274788 · last updated 2025-09-05