CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 90 enrolled
Drug / intervention
Omegaven™ +1 moredrug
Likely dose
Omegaven™ 1 gfrom 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/NCT01089426
NCT01089426N/ACompleted
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Research Study of an Intravenous Fat Emulsion Comprised of Fish Oils (Omegaven) in the Treatment of Parenteral Nutrition (PN) Induced Liver Injury

Children's Hospital Los Angeles·interventional·Posted Mar 18, 2010·Updated May 6, 2019

In Brief

A clinical study evaluating Omegaven™ and Historical Controls for Liver Injury. Completed, enrolled 90 participants across 1 site.

Detailed Summary

This study examines the hypothesis that administering intravenous fish oil, in lieu of intravenous soybean oil, can ameliorate the progression of PN-associated cholestatic liver disease in pediatric patients with elevated direct bilirubin requiring PN for more than 30 days.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLiver Injury
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 18, 2010
Enrollment StartSep 1, 2008
Primary CompletionApr 1, 2019
TodayJul 2, 2026
Enrollment to primary: 10.6 yearsPosted 16.3 years ago

Interventions

Omegaven™drug

1 g/kg/d of Omegaven until discontinuation of PN

Historical Controlsother

Standard of Care