Phase 3
Completed N=63
Compassionate Use of Omegaven in Children
Total Parenteral Nutrition-induced Cholestasis · Cholestasis · Short Bowel Syndrome · gastroschisis
Source: ClinicalTrials.gov NCT02370251 ↗
Enrolled (actual)
63
Serious AEs
17.3%
Results posted
Nov 2019
Primary outcomePrimary: Resolution of Cholestasis for Subjects Who Received Omegaven — 40; 10; 2 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This is a single-assignment study to evaluate whether Omegaven (IV fish oil) is effective at treating liver disease in children on long-term IV nutrition.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Resolution of Cholestasis for Subjects Who Received Omegaven |
40; 10; 2 | — |
| SECONDARY Safety Issues for Infants Who Received Omegaven |
10; 7; 6; 7; 39; 24 | — |
| SECONDARY Essential Fatty Acid Deficiency in Infants Who Received Omegaven |
14; 27; 11 | — |
Eligibility Criteria
Inclusion Criteria
- Live in or temporarily relocate to Oklahoma
- Age less than 18 years, both sexes, all races
- Have a direct bilirubin level of ≥2 mg/dL for two consecutive weeks after at least 14 days of parenteral nutrition
- Received parenteral lipids at a maximum dose of 1.7 g/kg/day (24 g/kg over the two weeks prior)
- Are not currently enrolled in another lipid emulsion study
Exclusion Criteria
- Known food allergy to fish
- Known metabolic disorder of lipid metabolism
- Active coagulopathies (active bleeding or requiring blood product treatment in the prior 48 hours)
- Medical condition likely to result in death in the next 30 days
Data sourced from ClinicalTrials.gov (NCT02370251). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.