CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 11 enrolled
Drug / intervention
Omegaven®drug
Likely dose
Omegaven® 0.5gfrom 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.

Search/NCT01845116
NCT01845116Phase 2Completed
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Use of a Fish Oil-Based Intravenous Lipid Emulsion (Omegaven®) in the Treatment of Parenteral Nutrition (PN) Induced Liver Injury

Wake Forest University Health Sciences·interventional·Posted May 3, 2013·Updated Nov 23, 2022

In Brief

A Phase 2 clinical trial evaluating Omegaven® for Total Parenteral Nutrition-induced Cholestasis. Completed, enrolled 11 participants across 1 site.

Detailed Summary

The purpose of this study is to determine whether the omega-3 fatty acid emulsion (Omegaven®), when used in place of the conventional soy-based fat emulsion (Intralipid), is effective in treating parenteral nutrition associated liver disease (PNALD) in children. The study hypothesis is that Omegaven® can be safely provided to children who are dependent on parenteral nutrition and have PNALD, and can reverse or prevent progression of PNALD until the child can take adequate nutrition by mouth.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTotal Parenteral Nutrition-induced Cholestasis
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 3, 2013
Enrollment StartJul 1, 2010
Primary CompletionJul 1, 2020
TodayJul 2, 2026
Enrollment to primary: 10 yearsPosted 13.2 years ago

Interventions

Omegaven®drug

10% Omegaven® initiated at a starting dose of 0.5g/kg/day for two days and then advancing to the goal dose of 1g/kg/day, IV (in the vein) until the patient no longer requires parenteral nutrition or until participation in the study is terminated.