Cholestasis Reversal: Efficacy of IV Fish Oil

Status: Completed
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

The purpose of this study is to determine whether Omegaven is effective in the treatment of parenteral nutrition associated liver disease (PNALD).

Eligibility
Participation Requirements
Sex: All
Maximum Age: 17
Healthy Volunteers: f
View:

• 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®).

Locations
United States
Massachusetts
Children's Hospital Boston
Boston
Time Frame
Start Date: 2006-08
Completion Date: 2019-01-23
Participants
Target number of participants: 91
Treatments
Experimental: Omegaven
1g/kg/day for duration of study participation for all participants
Authors
Sponsors
Leads: Mark Puder

This content was sourced from clinicaltrials.gov

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