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Compassionate Use of Omegaven in Children

NCT02370251 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2019-11-25

Study results available
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Summary

This is a single-assignment study to evaluate whether Omegaven (IV fish oil) is effective at treating liver disease in children on long-term IV nutrition.

Conditions

  • Total Parenteral Nutrition-induced Cholestasis
  • Cholestasis
  • Short Bowel Syndrome
  • Gastroschisis
  • Intestinal Atresia
  • Infant, Premature, Diseases
  • Cholestasis of Parenteral Nutrition

Interventions

DRUG

Omegaven

Once the direct bilirubin is 2 mg/dL or more x 2 weeks, Intralipid will be switched to Omegaven at 1 g/kg/day. The bilirubin level will be monitored to determine when resolution of cholestasis (DB \<2 mg/dL) occurs.

Sponsors & Collaborators

  • OU Medical Center

    collaborator UNKNOWN

  • University of Oklahoma

    lead OTHER

Principal Investigators

  • Kimberly D Ernst, MD, MSMI · The University of Oklahoma, Department of Pediatrics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2018-09-27
Completion
2019-09-27

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 NCT02370251 on ClinicalTrials.gov