Phase 2
N=72
Evaluation of Omegaven™ Parenteral Nutrition in Patients With Total Parenteral Nutrition (TPN)-Induced Cholestasis
Parenteral Nutrition Associated Liver Disease PNALD · Cholestasis
Bottom Line
View on ClinicalTrials.gov: NCT00826020 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Number of Patients With Progression to Small Bowel Transplantation. — 19 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Omegaven™ (Drug)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- University of Nebraska
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Progression to Small Bowel Transplantation. |
19 | — |
| SECONDARY Number of Subjects With Reversal of Biochemical Cholestasis |
56 | — |
Summary
The purpose of this study is to determine if established parenteral nutrition (PN) associated liver disease can be reversed or its progression halted by using a parenteral fat emulsion prepared from fish oil as measured by normalization of serum levels of hepatic enzymes and bilirubin.
Eligibility Criteria
Inclusion Criteria
- Patients must be enrolled in the Intestinal Rehabilitation Program at the University of Nebraska Medical Center, AND:
- Be unable to meet nutritional needs solely by enteral nutrition and be expected to require PN for at least another 30 days
- Have clinical evidence of parenteral nutrition associated liver disease (PNALD) as defined as a direct bilirubin of 2 mg/dl or more. A liver biopsy is desirable but not necessary for treatment
- Signed patient informed consent
Exclusion Criteria
- Parent or guardian or child unwilling to provide consent or assent
- Inability or unwillingness on the part of parent/guardian or child to follow clinical recommendations of the Intestinal Rehabilitation Program
- Allergies or clinical conditions precluding safe use of Omegaven™
Data sourced from ClinicalTrials.gov (NCT00826020). 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.