Trials / Approved For Marketing
Approved For MarketingNCT02778698
Compassionate Use of Omegaven
Compassionate Use of an Intravenous Fat Emulsion Comprised of Fish Oil in The Treatment of Parenteral Nutrition Induced Liver Injury in Children
- Status
- Approved For Marketing
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- Geisinger Clinic · Academic / Other
- Sex
- All
- Age
- 15 Days – 5 Years
- Healthy volunteers
- —
Summary
This expanded access protocol is for infants or children with conditions preventing them from taking in enough nutrients from food and must receive nutrition intravenously. Standard intravenous nutrition contains fat emulsion made from soybean. If this fat emulsion is given over a long period of time, it can cause problems within the liver and if persistent and not addressed can even lead to severe and/or permanent injury to the liver. It is believed that a type of fish oil blend, called Omegaven®, may be used in place of the soybean fat blend. The Omegaven® fish oil blend may greatly reduce the risk of liver injury. Omegaven® is not approved by the Food and Drug Administration (FDA). It is only offered under an "expanded access" protocol as an alternative to the soybean fat blend.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Omegaven |
Timeline
- First posted
- 2016-05-20
- Last updated
- 2019-03-12
Source: ClinicalTrials.gov record NCT02778698. Inclusion in this directory is not an endorsement.