Omegaven for Compassionate Use in the Treatment of Parenteral Nutrition-Associated Liver Disease (NCT03072667) | Clinical Trial Compass
APPROVED_FOR_MARKETINGNot Applicable
Omegaven for Compassionate Use in the Treatment of Parenteral Nutrition-Associated Liver Disease
United States
Plain-language summary
This is a compassionate use protocol of an investigational new drug (IND). The overall purpose of the treatment is to offer alternative treatment to children who developed parenteral nutrition-associated liver disease (PNALD) and have not responded positively to currently available medical therapies. PNALD develops in newborns dependent on parenteral nutrition (PN) and are unable to tolerate adequate enteral feedings to support fluid and nutritional fluids; although PN is necessary and life sustaining, it can result in severe liver disease.
Who can participate
Age range1 Year
SexALL
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Inclusion criteria
✓. Age \< 1 years; inpatient use only
✓. PN dependency (unable to meet nutritional needs solely by enteral nutrition);
✓. Present PNALD, as evidenced by two consecutive direct bilirubin \> 3.0 mg/dL (at interval of one week);
✓. Failed standard therapies to prevent the progression of liver disease:
✓. At the time the diagnosis PNALD is made, the patient is expected to continue PN at least an additional 3 weeks
Exclusion criteria
✕. Any other cause of chronic liver disease (i.e., hepatitis B or C, cystic fibrosis, biliary atresia, or alpha 1 anti-trypsin deficiency etc.)
✕. enrollment in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team);
✕. Lack of informed consent;
✕. Intent to transfer to another healthcare facility
✕. allergy to any seafood product, egg protein, and/or previous allergy to Omegaven
✕. active coagulopathy characterized by ongoing bleeding or by a requirement for clotting factor replacement (e.g. fresh frozen plasma or cryoprecipitate) to maintain homeostasis
✕. impaired lipid metabolism or severe hyperlipidemia with or without pancreatitis