Safety of Omegaven in Pediatric Patients With Parenteral Nutrition-Associated Cholestasis (PNAC) (NCT04807478) | Clinical Trial Compass
WithdrawnNot Applicable
Safety of Omegaven in Pediatric Patients With Parenteral Nutrition-Associated Cholestasis (PNAC)
Stopped: New study protocol under development
0Started 2022-04-01
Plain-language summary
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
Who can participate
Age range1 Day
SexALL
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Inclusion criteria
✓. Patient's parent(s) or legal guardian(s) has provided a signed and dated Informed Consent Form (ICF).
✓. 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.
✓. Patient has feeding intolerance or at least one gastrointestinal disorder requiring PN.
✓. Patient is \< 6 months corrected age (expected time of delivery to time of screening).
Exclusion criteria
✕. 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.
✕. Patient has known cirrhosis (liver biopsy is not required under this protocol).
✕. Patient has known portal vein thrombosis (imaging studies are not required under this protocol).
✕. Patient has previously received a liver-only or liver-inclusive transplant.
✕. Patient has a major cardiac anomaly with hemodynamic instability.
✕. Patient has a major life-threatening disease (e.g., sepsis requiring high-dose vasopressors, acute respiratory distress syndrome, veno-occlusive disease, cancer).
✕. 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.
What they're measuring
1
Incidence of:
Timeframe: Through study completion, a maximum of 6 years