Phase 3
Completed N=91
Cholestasis Reversal: Efficacy of IV Fish Oil
Parenteral Nutrition Associated Liver Disease · Short Bowel Syndrome · gastrointestinal
Source: ClinicalTrials.gov NCT00910104 ↗
Enrolled (actual)
91
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcomePrimary: Reversal of Cholestasis, Defined as a Direct Bilirubin to <= 2.0 mg/dL. — 11.7; 6.4 Weeks — p==0.001
◆ Published Evidence
Highly cited
381citations · ~22 / year
Parenteral fish oil improves outcomes in patients with parenteral nutrition-associated liver injury.
Summary
The purpose of this study is to determine whether Omegaven is effective in the treatment of parenteral nutrition associated liver disease (PNALD).
Linked Publications (5)
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Parenteral fish oil improves outcomes in patients with parenteral nutrition-associated liver injury.
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Fish Oil Emulsion Reduces Liver Injury and Liver Transplantation in Children with Intestinal Failure-Associated Liver Disease: A Multicenter Integrated Study.
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Predictors of failure of fish-oil therapy for intestinal failure-associated liver disease in children.
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Intravenous Fish Oil Monotherapy as a Source of Calories and Fatty Acids Promotes Age-Appropriate Growth in Pediatric Patients with Intestinal Failure-Associated Liver Disease.
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Use of Intravenous Soybean and Fish Oil Emulsions in Pediatric Intestinal Failure-Associated Liver Disease: A Multicenter Integrated Analysis Report on Extrahepatic Adverse Events.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reversal of Cholestasis, Defined as a Direct Bilirubin to <= 2.0 mg/dL. |
11.7; 6.4 | =0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Patients will be PN dependent (unable to meet nutritional needs solely by enteral nutrition) and are expected to require PN for at least another 30 days
- Patients considered eligible for study participation must have parenteral nutrition associated liver disease (PNALD) as defined as a direct bilirubin of > 2 mg/dl or currently on Omegaven through another protocol. Other causes of liver disease should be excluded. A liver biopsy is not necessary for treatment.
- Direct bilirubin > 2.0 mg/dl or already on Omegaven through another protocol
- Signed patient informed consent.
- The patient must have utilized standard therapies to prevent the progression of his/her liver disease including surgical treatment, cyclic PN, avoiding overfeeding, reduction/removal of copper and manganese from PN, advancement of enteral feeding, and the use of ursodiol (i..e., Actigall®).
Exclusion Criteria
- Pregnancy
- Other causes of chronic liver disease (Hepatitis C, biliary atresia, and alpha 1 anti-trypsin deficiency).
- Enrollment in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team)
- The parent or guardian or child unwilling to provide consent or assent
In rare instances, patients diagnosed with PNALD may later be found to have liver disease due to other causes in addition to the use of PN (i.e., inborn errors of metabolism, viral infections ). Such causes may not be known at the time of enrollment and will not preclude them from continuing in the study. For the sake of statistical analysis, however, these patients will be excluded although all data will be collected and reviewed.
Data sourced from ClinicalTrials.gov (NCT00910104) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.