Phase 3
Completed N=2
Use of Omegaven for Treatment With Parenteral Nutrition Associated Liver Disease
Parenteral Nutrition-related Hepatitis
Source: ClinicalTrials.gov NCT04697888 ↗
Enrolled (actual)
2
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcomePrimary: Disease Progression as Measured by Serum Levels of Hepatic Enzymes
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
To provide parenteral fat emulsion prepared from fish oil (omega-3 fatty acid emulsion, Omegaven®) to patients with liver disease (PNALD).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease Progression as Measured by Serum Levels of Hepatic Enzymes |
— | — |
Eligibility Criteria
Inclusion Criteria
- The patient will be PN dependent and unable to meet nutritional needs solely by enteral nutrition.
- Patient will be 2.0mg/dl
- The patient must have failed standard therapies to prevent progression his/her liver disease.
Exclusion Criteria
- Other causes of chronic liver disease (Hepatitis C, Cystic fibrosis, biliary atresia, and alpha 1 anti-trypsin deficiency).
- Patients who are allergic to eggs/shellfish
- Patients who have severe hemorrhagic disorders.
Data sourced from ClinicalTrials.gov (NCT04697888). 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.