Trials / Completed
CompletedNCT04697888
Use of Omegaven for Treatment With Parenteral Nutrition Associated Liver Disease
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 2 (actual)
- Sponsor
- Children's Mercy Hospital Kansas City · Academic / Other
- Sex
- All
- Age
- 17 Years
- Healthy volunteers
- Not accepted
Summary
To provide parenteral fat emulsion prepared from fish oil (omega-3 fatty acid emulsion, Omegaven®) to patients with liver disease (PNALD).
Detailed description
This is a compassionate use protocol for patients with PNALD who have failed traditional treatment to receive Omegaven through an IND. Omegaven will be infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Omegaven | Expanded Access Therapy with Omegaven will be initiated at a starting dose of 0.5 gm/kg/day to be infused over 24 hrs. After two days of infusion the dose will be increased to 1gm/kg/day. |
Timeline
- Start date
- 2013-04-01
- Primary completion
- 2018-11-01
- Completion
- 2018-11-01
- First posted
- 2021-01-06
- Last updated
- 2021-06-11
- Results posted
- 2021-03-12
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04697888. Inclusion in this directory is not an endorsement.