At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 2 enrolled
Drug / intervention
Omegavendrug
Likely dose
Not stated in 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.
Use of Omegaven for Treatment With Parenteral Nutrition Associated Liver Disease
In Brief
A Phase 3 clinical trial evaluating Omegaven for Parenteral Nutrition-related Hepatitis. Completed, enrolled 2 participants across 1 site.
Detailed Summary
To provide parenteral fat emulsion prepared from fish oil (omega-3 fatty acid emulsion, Omegaven®) to patients with liver disease (PNALD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParenteral Nutrition-related Hepatitis
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2013
Primary CompletionNov 2018
First PostedJan 2021
TodayJul 2026
First PostedJan 6, 2021
Enrollment StartApr 1, 2013
Primary CompletionNov 1, 2018
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 5.5 years ago
Interventions
Omegavendrug
Expanded Access Therapy with Omegaven will be initiated at a starting dose of 0.5 gm/kg/day to be infused over 24 hrs. After two days of infusion the dose will be increased to 1gm/kg/day.