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NCT01173159 · ClinicalTrials.gov registry record · NA

Compassionate Use of Omegaven to Reverse Parenteral Nutrition Induced Cholestasis

A NA study, sponsored by Children's Hospital Medical Center, Cincinnati.

Completed
Registry status
NA
Development phase
10
Enrollment target

NCT01173159: Completed NA study, sponsored by Children's Hospital Medical Center, Cincinnati.

NCT01173159 is a NA study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01173159, a NA study, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.

COMPLETED
Registry status
NA
Development phase
10 participants
Enrollment target

Study Summary

The purpose of this research study is to see if giving Omegaven (an intravenous fat emulsion containing fish oil) instead of the current lipid emulsion, which contains fat derived from soybeans, as part of your child's intravenous (IV) nutrition therapy may be tolerated better. It may reduce the harmful effects to the liver, may stop any further liver damage and may reverse damage already done to the liver because of the prolonged use of nutrition through your child's IV.

Primary Outcome

Change in conjugated/direct bilirubin level to below 1 mg/dl.

Interventions

  • DRUG Omegaven

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2010-07
Est. Completion 2018-12
Phase NA

What the finished NCT01173159 record still lists

NCT01173159 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 1 intervention - of which Omegaven is the first listed.

NCT01173159 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01173159 about?

NCT01173159 is a clinical study titled "Compassionate Use of Omegaven to Reverse Parenteral Nutrition Induced Cholestasis". The purpose of this research study is to see if giving Omegaven (an intravenous fat emulsion containing fish oil) instead of the current lipid emulsion, which contains fat derived from soybeans, as part of your child's intravenous (IV) nutrition therapy may be tolerated better. It may reduce the har...

What is the current status of trial NCT01173159?

This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2010-07. Estimated completion is 2018-12.

What interventions are being tested in trial NCT01173159?

The interventions under investigation include: Omegaven (DRUG).

Who is sponsoring clinical trial NCT01173159?

This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01173159's enrollment target sits among peer trials

10 1927th of 2000 higher than 26 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01173159, the US trial registry maintained by the National Library of Medicine. NCT01173159 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.