Phase 3
N=2
Use of Omegaven for Treatment With Parenteral Nutrition Associated Liver Disease
Parenteral Nutrition-related Hepatitis
Bottom Line
View on ClinicalTrials.gov: NCT04697888 ↗Enrolled (actual)
2
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: Disease Progression as Measured by Serum Levels of Hepatic Enzymes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Omegaven (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Children's Mercy Hospital Kansas City
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease Progression as Measured by Serum Levels of Hepatic Enzymes |
— | — |
Summary
To provide parenteral fat emulsion prepared from fish oil (omega-3 fatty acid emulsion, Omegaven®) to patients with liver disease (PNALD).
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.