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Compassionate Use of Omegaven IV Fat Emulsion

NCT01323907 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-02-06

No results posted yet for this study

Summary

The purpose of the study is to provide use of Omegaven in children with life threatening Total Parenteral Nutrition (TPN) associated cholestasis when all other medical and surgical treatments/therapies have been either ineffective or not feasible in the treatment of this serious condition. This is a compassionate use protocol.

Conditions

  • Total Parenteral Nutrition-induced Cholestasis

Interventions

DRUG

Omegaven IV lipid emulsion

For infants meeting inclusion criteria and whose guardians consent to participation, Omegaven will be initiated at the dose of 0.5gram/kg/day and is infused over 24 hours for 1-2 days and then advanced to 1 gram/kg/day. Omegaven will be infused intravenously through a central or peripheral catheter alone or in conjunction with parenteral nutrition.

Sponsors & Collaborators

  • Sivan Kinberg

    lead OTHER

Principal Investigators

  • Sivan Kinberg, MD, MS · Columbia University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2019-02-13
Completion
2019-02-13

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 NCT01323907 on ClinicalTrials.gov