Cholestasis Reversal: Efficacy of IV Fish Oil

Sponsor

Mark Puder (Other)

Overall Status

Completed

CT.gov ID

NCT00910104

Collaborator

(none)

290

Enrollment

Location

Arm

172.7

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Parenteral Nutrition Associated Liver Disease Short Bowel Syndrome Gastrointestinal Disease	Drug: Omegaven®	Phase 2/Phase 3

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 of parenteral nutrition associated liver disease (PNALD).

Study Design

Study Type:

Interventional

Actual Enrollment :

290 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Cholestasis Reversal: Efficacy of IV Fish Oil

Actual Study Start Date :

Sep 1, 2004

Actual Primary Completion Date :

Jan 23, 2019

Actual Study Completion Date :

Jan 23, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Omegaven 1g/kg/day for duration of study participation for all participants	Drug: Omegaven® 10% Omegaven® 1g/kg/day, IV (in the vein) until the patient no longer requires parenteral nutrition or until participation in the study is terminated

Arm

Intervention/Treatment

Experimental: Omegaven

1g/kg/day for duration of study participation for all participants

Drug: Omegaven®

10% Omegaven® 1g/kg/day, IV (in the vein) until the patient no longer requires parenteral nutrition or until participation in the study is terminated

Outcome Measures

Primary Outcome Measures

Efficacy of parenteral administration of fish oil derived fat emulsion (Omegaven®) to reverse established parenteral nutrition associated liver disease [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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.