Trials / Withdrawn
WithdrawnNCT01323907
Compassionate Use of Omegaven IV Fat Emulsion
Compassionate Use of Omegaven IV Fat Emulsion in Infants With Life Threatening Parenteral Nutrition-associated Liver Disease (PNALD).
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Sivan Kinberg · Academic / Other
- Sex
- All
- Age
- 2 Months – 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to provide use of Omegaven in children with life threatening Total Parenteral Nutrition (TPN) associated cholestasis when all other medical and surgical treatments/therapies have been either ineffective or not feasible in the treatment of this serious condition. This is a compassionate use protocol.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Omegaven IV lipid emulsion | For infants meeting inclusion criteria and whose guardians consent to participation, Omegaven will be initiated at the dose of 0.5gram/kg/day and is infused over 24 hours for 1-2 days and then advanced to 1 gram/kg/day. Omegaven will be infused intravenously through a central or peripheral catheter alone or in conjunction with parenteral nutrition. |
Timeline
- Start date
- 2011-01-01
- Primary completion
- 2019-02-13
- Completion
- 2019-02-13
- First posted
- 2011-03-28
- Last updated
- 2020-02-06
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01323907. Inclusion in this directory is not an endorsement.