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Compassionate Use of an Intravenous Fish Oil Emulsion in Infants With Cholestasis

NCT01601652 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-01-27

Study results available
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Summary

The study will evaluate the safety and efficacy of an intravenous fish oil emulsion (omegaven) in infants with parenteral nutrition associated cholestasis.

Conditions

  • Parenteral Nutrition Associated Cholestasis

Interventions

DRUG

Omegaven

1 g/kg/d iv infusion over 24h

Sponsors & Collaborators

  • Arthur J De Lorimier

    lead OTHER

Principal Investigators

  • Ian J Griffin, MD · UC Davis

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2018-12-31
Completion
2018-12-31

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 NCT01601652 on ClinicalTrials.gov