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A Safety and Efficacy Study to Determine if Giving Intravenous Fish Oil Helps Children With Liver Disease

NCT00969332 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2020-02-26

Study results available
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Summary

The purpose of the study is to investigate if intravenous fish oil, commercially available as Omegaven, safely and effectively reverses parenteral nutrition associated cholestasis in children.

Conditions

  • Cholestasis

Interventions

DRUG

Omegaven

0.5 g/kg/d intravenous every day for 2 days, then 1 g/kg/d intravenous everyday

Sponsors & Collaborators

Principal Investigators

  • Kara L Calkins, MD · University of California, Los Angeles

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Weeks
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2019-01-12
Completion
2019-02-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT00969332 on ClinicalTrials.gov