At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 91 enrolled
Drug / intervention
Omegaven®drug
Likely dose
Omegaven® 1gfrom 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.
Cholestasis Reversal: Efficacy of IV Fish Oil
In Brief
A Phase 3 clinical trial evaluating Omegaven® for Parenteral Nutrition Associated Liver Disease and 2 related conditions. Completed, enrolled 91 participants across 1 site.
Detailed Summary
The purpose of this study is to determine whether Omegaven is effective in the treatment of parenteral nutrition associated liver disease (PNALD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParenteral Nutrition Associated Liver Disease, Short Bowel Syndrome, Gastrointestinal Disease
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2006
First PostedMay 2009
Primary CompletionJan 2019
TodayJul 2026
First PostedMay 29, 2009
Enrollment StartAug 1, 2006
Primary CompletionJan 23, 2019
TodayJul 2, 2026
Enrollment to primary: 12.5 yearsPosted 17.1 years ago
Interventions
Omegaven®drug
10% Omegaven® 1g/kg/day, IV (in the vein) until the patient no longer requires parenteral nutrition or until participation in the study is terminated