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Omegaven Treatment of Parenteral Nutrition (PN) Induced Liver Injury

NCT01089426 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2019-05-06

No results posted yet for this study

Summary

This study examines the hypothesis that administering intravenous fish oil, in lieu of intravenous soybean oil, can ameliorate the progression of PN-associated cholestatic liver disease in pediatric patients with elevated direct bilirubin requiring PN for more than 30 days.

Conditions

  • Liver Injury

Interventions

DRUG

Omegaven™

1 g/kg/d of Omegaven until discontinuation of PN

OTHER

Historical Controls

Standard of Care

Sponsors & Collaborators

Principal Investigators

  • Russell Merritt, M.D., PhD · Children's Hospital Los Angeles

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2019-04-30
Completion
2019-04-30

Countries

  • United States

Study Locations

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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 NCT01089426 on ClinicalTrials.gov