At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 63 enrolled
Drug / intervention
Omegavendrug
Likely dose
Omegaven 2 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Fish Oil Lipid Emulsion for the Treatment of Parenteral-Nutrition-Associated Liver Disease in Infants
In Brief
A Phase 3 clinical trial evaluating Omegaven for Total Parenteral Nutrition-induced Cholestasis and 6 related conditions. Completed, enrolled 63 participants across 1 site.
Detailed Summary
This is a single-assignment study to evaluate whether Omegaven (IV fish oil) is effective at treating liver disease in children on long-term IV nutrition.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTotal Parenteral Nutrition-induced Cholestasis, Cholestasis, Short Bowel Syndrome, Gastroschisis, Intestinal Atresia, Infant, Premature, Diseases, Cholestasis of Parenteral Nutrition
CountriesUnited States
CollaboratorsOU Medical Center
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 2015
Enrollment StartJun 2015
Primary CompletionSep 2018
Study CompletionSep 2019
TodayJul 2026
First PostedFeb 24, 2015
Enrollment StartJun 1, 2015
Primary CompletionSep 27, 2018
Study CompletionSep 27, 2019
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 11.4 years ago
Interventions
Omegavendrug
Once the direct bilirubin is 2 mg/dL or more x 2 weeks, Intralipid will be switched to Omegaven at 1 g/kg/day. The bilirubin level will be monitored to determine when resolution of cholestasis (DB \<2 mg/dL) occurs.