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Omegaven as Alternative Parenteral Fat Nutrition

NCT03662282 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2020-07-22

Study results available
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Summary

To provide Omegaven® as a compassionate treatment for critically ill infants with parenteral nutrition associated cholestasis

Conditions

  • Cholestasis
  • Cholestasis of Parenteral Nutrition

Interventions

DRUG

Omegaven

Omegaven® fat emulsion will be used as a compassionate use treatment for critically ill infants with parenteral nutrition associated liver injury

Sponsors & Collaborators

  • University of South Florida

    lead OTHER

Principal Investigators

  • Thao Ho, DO · University of South Florida

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-23
Primary Completion
2019-01-07
Completion
2019-01-07
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 NCT03662282 on ClinicalTrials.gov