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Evaluation of Omegaven™ Parenteral Nutrition in Patients With Total Parenteral Nutrition (TPN)-Induced Cholestasis

NCT00826020 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2023-10-05

Study results available
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Summary

The purpose of this study is to determine if established parenteral nutrition (PN) associated liver disease can be reversed or its progression halted by using a parenteral fat emulsion prepared from fish oil as measured by normalization of serum levels of hepatic enzymes and bilirubin.

Conditions

  • Parenteral Nutrition Associated Liver Disease PNALD
  • Cholestasis

Interventions

DRUG

Omegaven™

10% Omegaven™, 50 or 100 mL bottle; 1gram/kg/day and is infused over 12-24 hours.

Sponsors & Collaborators

  • University of Nebraska

    lead OTHER

Principal Investigators

  • David F Mercer, MD, PhD · University of Nebraska

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-01
Primary Completion
2017-10-06
Completion
2017-10-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00826020 on ClinicalTrials.gov