Status:
COMPLETED
Omegaven® in the Treatment of Parenteral Nutrition (PN) Induced Liver Injury
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Total Parenteral Nutrition-induced Cholestasis
Eligibility:
All Genders
4-18 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether the omega-3 fatty acid emulsion (Omegaven®), when used in place of the conventional soy-based fat emulsion (Intralipid), is effective in treating pare...
Detailed Description
Rationale for Omegaven® Treatment Unlike conventional intravenous fat emulsions, Omegaven® is comprised solely of fish oils containing primarily omega-3 fatty acids. Animal studies have shown that IV...
Eligibility Criteria
Inclusion
- Children 0-18 years of age
- Patients will be PN-dependent and expected to continue PN for at least 30 days
- Patients considered eligible for study participation must have PN-associated liver diseases . Other causes of liver disease (i.e., biliary atresia, galactosemia, alpha-1 antitrypsin deficiency) will be excluded. A liver biopsy is not necessary for treatment
- Direct bilirubin \> 2.0 mg/dl
- Signed patient informed consent
- Signed patient assent where applicable.
Exclusion
- Pregnancy
- Other causes of chronic liver disease (cystic fibrosis, biliary atresia, alpha-1 antitrypsin deficiency)
- Signs of advanced liver disease including cirrhosis on biopsy, varices, ascites
- The patient is allergic to eggs/shellfish
- The patient has a severe hemorrhagic disorder
- The patient is enrolled in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team)
- The parent or guardian or child unwilling to provide consent or assent.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2020
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT01845116
Start Date
July 1 2010
End Date
July 1 2020
Last Update
November 23 2022
Active Locations (1)
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1
Levine Children's Hospital at Carolinas HealthCare System
Charlotte, North Carolina, United States, 28232-2861