Trials / Approved For Marketing
Approved For MarketingNCT01861834
Safer Parenteral Nutrition in Pediatric Short Bowel Syndrome to Decrease Liver Damage
A Safer Approach to Total Parenteral Nutrition in Pediatric Short Bowel Syndrome Intended to Decrease the Frequency and Severity of Liver Damage
- Status
- Approved For Marketing
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- Georgetown University · Academic / Other
- Sex
- All
- Age
- 2 Months – 18 Years
- Healthy volunteers
- —
Summary
To provide children dependent on total parenteral nutrition with Omegaven®, a fish oil-based intravenous lipid emulsion that may be less hepatotoxic than conventional, vegetable oil-based intravenous lipid emulsions, and that may therefore reduce the need for liver transplantation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Omegaven 10% | Patients with a sustained TPN requirement due to short bowel syndrome and TPN-associated liver disease that threatens progression to liver failure and death, for which the only available means of prevention at present is timely liver and/or intestinal transplant. Omegaven 10%, 1 gram/kg, IV, every 12 hours until transplantation, or stopping TPN |
Timeline
- First posted
- 2013-05-24
- Last updated
- 2019-05-07
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01861834. Inclusion in this directory is not an endorsement.