Trials / Completed
CompletedNCT02370251
Compassionate Use of Omegaven in Children
Fish Oil Lipid Emulsion for the Treatment of Parenteral-Nutrition-Associated Liver Disease in Infants
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 63 (actual)
- Sponsor
- University of Oklahoma · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Children up to 18 years of age, on parenteral nutrition, with a direct bilirubin level of 2 mg/dL or greater will be eligible to receive Omegaven at a maximum dose of 1 g/kg/day. Up to 200 children will be eligible for enrollment. Direct bilirubin levels and other labs will be monitored as well as growth parameters.
Conditions
- Total Parenteral Nutrition-induced Cholestasis
- Cholestasis
- Short Bowel Syndrome
- Gastroschisis
- Intestinal Atresia
- Infant, Premature, Diseases
- Cholestasis of Parenteral Nutrition
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Omegaven | Once the direct bilirubin is 2 mg/dL or more x 2 weeks, Intralipid will be switched to Omegaven at 1 g/kg/day. The bilirubin level will be monitored to determine when resolution of cholestasis (DB \<2 mg/dL) occurs. |
Timeline
- Start date
- 2015-06-01
- Primary completion
- 2018-09-27
- Completion
- 2019-09-27
- First posted
- 2015-02-24
- Last updated
- 2019-11-25
- Results posted
- 2019-11-25
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02370251. Inclusion in this directory is not an endorsement.