CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 12 enrolled
Drug / intervention
Omegavendrug
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/NCT01601652
NCT01601652Phase 2Completed
CompareCT.gov

Open Label, Compassionate Use Protocol of an Intravenous Fish Oil Emulsion in Infants With Cholestasis

Arthur J De Lorimier·interventional·Posted May 18, 2012·Updated Jan 27, 2021

In Brief

A Phase 2 clinical trial evaluating Omegaven for Parenteral Nutrition Associated Cholestasis. Completed, enrolled 12 participants across 1 site.

Detailed Summary

The study will evaluate the safety and efficacy of an intravenous fish oil emulsion (omegaven) in infants with parenteral nutrition associated cholestasis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParenteral Nutrition Associated Cholestasis
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 18, 2012
Enrollment StartNov 1, 2011
Primary CompletionDec 1, 2018
TodayJul 2, 2026
Enrollment to primary: 7.1 yearsPosted 14.1 years ago

Interventions

Omegavendrug

1 g/kg/d iv infusion over 24h