Phase 3 N=63 Treatment

Compassionate Use of Omegaven in Children

Total Parenteral Nutrition-induced Cholestasis · Cholestasis · Short Bowel Syndrome · Gastroschisis · Intestinal Atresia

Bottom Line

View on ClinicalTrials.gov: NCT02370251 ↗

Enrolled (actual)

Serious AEs

17.3%

Results posted

Nov 2019

Primary outcome: Primary: Resolution of Cholestasis for Subjects Who Received Omegaven — 40; 10; 2 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Omegaven (Drug)
Age: Pediatric, Adult
Sex: All
Sponsor: University of Oklahoma
Primary completion: Sep 2018

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	—

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.

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

View full record on ClinicalTrials.gov →

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.