Phase 2
N=12
Compassionate Use of an Intravenous Fish Oil Emulsion in Infants With Cholestasis
Parenteral Nutrition Associated Cholestasis
Bottom Line
View on ClinicalTrials.gov: NCT01601652 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Normalization of Conjugated Bilirubin (Conjugated Bilirubin < 2 mg/dL) — 2 mg/dl
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Omegaven (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Arthur J De Lorimier
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Normalization of Conjugated Bilirubin (Conjugated Bilirubin < 2 mg/dL) |
2 | — |
| SECONDARY Liver Transaminases |
98 | — |
Summary
The study will evaluate the safety and efficacy of an intravenous fish oil emulsion (omegaven) in infants with parenteral nutrition associated cholestasis.
Eligibility Criteria
Inclusion Criteria
Cholestasis defined as either
- serum bilirubin > 2mg/dL (two measurements at least 8d apart) that has not responded to 4 weeks of intralipid being reduced to 1 g/kg/d and trace minerals being limited to twice weekly, OR
- serum bilirubin > 6 mg/dL (single measurement) and rising, in the absence of proven or suspected sepsis
Exclusion Criteria
- Age > 1y at time that omegaven is started
- Not expected to survive at least 30 days
- Fish allergy in a first degree relative
- Hemodynamic instability
- Coagulopathy
- Not likely to require PN for > 30d
- Not expected to survive > 30d
Data sourced from ClinicalTrials.gov (NCT01601652). 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.