N/A
N=10
Compassionate Use of Omegaven to Reverse Parenteral Nutrition Induced Cholestasis
Cholestasis
Bottom Line
View on ClinicalTrials.gov: NCT01173159 ↗Enrolled (actual)
10
Serious AEs
40.0%
Results posted
May 2020
Primary outcome: Primary: Number of Participants With a Change in Conjugated/Direct Bilirubin — 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Omegaven (Drug)
- Age
- Pediatric, Adult · 0+ yrs
- Sex
- All
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Change in Conjugated/Direct Bilirubin |
4 | — |
| SECONDARY Number of Participants With a Change in Unconjugated/Total Bilirubin |
5 | — |
| SECONDARY Number of Participants With a Change in Aspartate Transaminase (AST) |
2 | — |
| SECONDARY Number of Participants With a Change in Liver Enzyme (ALT) |
1 | — |
| SECONDARY Number of Participants With a Change in Liver Enzyme Alkaline Phosphatase |
3 | — |
| SECONDARY Number of Participants With a Change in Liver Enzyme Gamma-glutamyltransferase (GGT) |
— | — |
| SECONDARY Number of Participants With a Change in Triglycerides |
8 | — |
Summary
The purpose of this research study is to see if giving Omegaven (an intravenous fat emulsion containing fish oil) instead of the current lipid emulsion, which contains fat derived from soybeans, as part of your child's intravenous (IV) nutrition therapy may be tolerated better. It may reduce the harmful effects to the liver, may stop any further liver damage and may reverse damage already done to the liver because of the prolonged use of nutrition through your child's IV.
Eligibility Criteria
Inclusion Criteria
- Males and females ages one month of age to 18 years of age
- Patients with intestinal failure on TPN
- Patients who have a conjugated/direct bilirubin of ≥3 mg/dl for more than weeks and in whom other causes of cholestasis have been excluded with reasonable certainty utilizing biochemical, serologic, microbiologic, and radiographic techniques. Liver biopsy is not required to rule out other disorders, but may be utilized at the clinician's discretion
- Patients in whom reduction of IV soy-based lipid to an average 1000 mg/dL) while on
1g/kg/day or less of Intralipid
- History of severe hemorrhagic disorders (ie. hemophilia, Von Willebrand disease, etc.)
- Unstable diabetes mellitus
- Collapse and shock
- Stroke/ Embolism
- Cardiac infarction within the last 3 months
- Undefined coma status
- Pregnancy (positive pregnancy test) prior to enrollment in the study for females of child-bearing potential
- Females of child-bearing potential who are unwilling to use birth control during study participation
- Parental decision to forego the use of Omegaven®
- Known fish or egg allergy
- Pregnancy
- Causes of liver disease other than Parenteral Nutrition Associated Cholestasis
Data sourced from ClinicalTrials.gov (NCT01173159). 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.