Status:
COMPLETED
Cholestasis Reversal: Efficacy of IV Fish Oil
Lead Sponsor:
Mark Puder
Conditions:
Parenteral Nutrition Associated Liver Disease
Short Bowel Syndrome
Eligibility:
All Genders
Up to 17 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to determine whether Omegaven is effective in the treatment of parenteral nutrition associated liver disease (PNALD).
Detailed Description
The purpose of this study is to determine whether the omega-3 fatty acid emulsion (Omegaven), when used in lieu of the conventional soy-based fat emulsion (Intralipid), is effective in the treatment o...
Eligibility Criteria
Inclusion
- Patients will be PN dependent (unable to meet nutritional needs solely by enteral nutrition) and are expected to require PN for at least another 30 days
- Patients considered eligible for study participation must have parenteral nutrition associated liver disease (PNALD) as defined as a direct bilirubin of \> 2 mg/dl or currently on Omegaven through another protocol. Other causes of liver disease should be excluded. A liver biopsy is not necessary for treatment.
- Direct bilirubin \> 2.0 mg/dl or already on Omegaven through another protocol
- Signed patient informed consent.
- The patient must have utilized standard therapies to prevent the progression of his/her liver disease including surgical treatment, cyclic PN, avoiding overfeeding, reduction/removal of copper and manganese from PN, advancement of enteral feeding, and the use of ursodiol (i..e., Actigall®).
Exclusion
- Pregnancy
- Other causes of chronic liver disease (Hepatitis C, biliary atresia, and alpha 1 anti-trypsin deficiency).
- Enrollment 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
- In rare instances, patients diagnosed with PNALD may later be found to have liver disease due to other causes in addition to the use of PN (i.e., inborn errors of metabolism, viral infections ). Such causes may not be known at the time of enrollment and will not preclude them from continuing in the study. For the sake of statistical analysis, however, these patients will be excluded although all data will be collected and reviewed.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 23 2019
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT00910104
Start Date
August 1 2006
End Date
January 23 2019
Last Update
September 19 2024
Active Locations (1)
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1
Children's Hospital Boston
Boston, Massachusetts, United States, 02115