CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 72 enrolled
Drug / intervention
Omegaven™drug
Likely dose
Omegaven™ 100 mLfrom 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/NCT00826020
NCT00826020Phase 2Completed
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Prospective Evaluation of a Parenteral Omega-3 Fatty Acid Preparation (Omegaven™) in Therapy of Patients With TPN-Induced Cholestasis

University of Nebraska·interventional·Posted Jan 21, 2009·Updated Oct 5, 2023

In Brief

A Phase 2 clinical trial evaluating Omegaven™ for Parenteral Nutrition Associated Liver Disease PNALD and Cholestasis. Completed, enrolled 72 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParenteral Nutrition Associated Liver Disease PNALD, Cholestasis
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 21, 2009
Enrollment StartMay 1, 2009
Primary CompletionOct 6, 2017
TodayJul 2, 2026
Enrollment to primary: 8.4 yearsPosted 17.4 years ago

Interventions

Omegaven™drug

10% Omegaven™, 50 or 100 mL bottle; 1gram/kg/day and is infused over 12-24 hours.