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Omega-3 Fatty Acid

Omegaven® for Cholestasis

Q: What are the potential risks and hazards associated with the administration of Omegaven® to individuals?

<p>Based on our assessment, the safety of Omegaven® in this Phase 2 trial is estimated to be at a level 2. Though there is some data supporting its safety, no evidence has been found yet regarding its efficacy.</p>

Phase 2

Waitlist Available

Led By Brian A Jones, MD

Research Sponsored by Brian Jones, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Parenteral nutrition associated liver disease (PNALD) as defined as a direct bilirubin ≥ 2mg/dL or by histology and/or currently on Omegaven through another protocol.

Parenteral nutrition (PN) dependent (unable to meet nutritional needs solely by enteral nutrition) and expected to require PN for at least another 30 days.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial aims to find out if using a fish oil based fat emulsion called Omegaven® instead of the usual soybean oil based fat emulsions can help reverse or stop the development of

Who is the study for?

This trial is for children who depend on parenteral nutrition (PN) and have liver disease due to PN, with a direct bilirubin level of at least 2mg/dL. They should need PN for the next 30 days or more and not have other causes of liver disease. Children already receiving Omegaven under another protocol can also join.Check my eligibility

What is being tested?

The study tests if Omegaven®, a fish oil based fat emulsion, can stop or reverse liver damage caused by standard soybean oil based fat emulsions in children dependent on parenteral nutrition.See study design

What are the potential side effects?

While specific side effects are not listed here, generally, fish oil-based emulsions like Omegaven® may cause allergic reactions, bleeding issues due to thinning blood, infections at the infusion site, and changes in blood test results.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have liver disease from IV nutrition, shown by high bilirubin or tests, and am on Omegaven.

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I rely on IV nutrition and will need it for at least another month.

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I have tried all standard treatments for my liver disease without success.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Primary efficacy outcome will be normalized direct bilirubin, defined as three consecutive direct bilirubin results < 2mg/dL or a direct bilirubin < 2mg/dL and weaned from total parenteral nutrition (TPN).

Side effects data

From 2019 Phase 4 trial • 48 Patients • NCT00862446

10%

Hypertriglyceridemia

Coagulopathy

100%

80%

60%

40%

20%

Study treatment Arm

Omegaven Treatment

Trial Design

1Treatment groups

Experimental Treatment

Group I: Omegaven®Experimental Treatment1 Intervention

Omegaven® 10% fat emulsion 1g/kg/day to infuse via IV over a period of 8-24 hours every day until the patient no longer requires intravenous lipid emulsion, is determined ineffective, or the patient stops participating in the study for any reason.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fish oil

FDA approved

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Brian Jones, MDLead Sponsor

Children's Hospital and Medical Center, Omaha, NebraskaOTHER

7 Previous Clinical Trials

5,000,671 Total Patients Enrolled

University of NebraskaLead Sponsor

540 Previous Clinical Trials

1,144,758 Total Patients Enrolled

1 Trials studying Cholestasis

72 Patients Enrolled for Cholestasis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the potential risks and hazards associated with the administration of Omegaven® to individuals?

"Based on our assessment, the safety of Omegaven® in this Phase 2 trial is estimated to be at a level 2. Though there is some data supporting its safety, no evidence has been found yet regarding its efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Compassionate Use of Omegaven® for the Treatment of Intestinal Failure Associated Liver Disease in Children

Brian Jones, MD 2024. "Compassionate Use of Omegaven® for the Treatment of Intestinal Failure Associated Liver Disease in Children". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02328768.

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