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Omega-3 Fatty Acid Emulsion

Omegaven for Cholestasis

N/A

Waitlist Available

Led By William Stratton, MD

Research Sponsored by Carle Foundation Hospital

Eligibility Criteria Checklist

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

Must have

Patients will be PN dependent (unable to meet nutritional needs solely by enteral nutrition) and are expected to require PN for at least 4 more weeks

Have PN-associated cholestasis defined as at least 2 consecutive direct bilirubin >2 mg/dL with anatomical or functional short gut (OR >4 mg/dL if intact intestine) obtained at least 1 week apart with a ratio of direct: total bilirubin > 0.4

Timeline

Screening 3 weeks

Treatment Varies

Follow Up until weaned from pn

Awards & highlights

Study Summary

This trial will test if a fat emulsion made of omega-3 fatty acids can help manage steatotic liver injury in patients receiving parenteral nutrition.

Who is the study for?

This trial is for individuals over 14 days old with PN-associated cholestasis, a liver condition caused by long-term parenteral nutrition. They must have tried standard treatments without success and be expected to need PN for at least another month. Excluded are those with other causes of cholestasis, known allergies to fish or eggs, certain medical conditions like unstable diabetes, or who are on conflicting medications.Check my eligibility

What is being tested?

The study tests Omegaven, an omega-3 fatty acid fat emulsion, as a treatment for liver injury in patients receiving parenteral nutrition. It aims to see if Omegaven can reduce harmful inflammation and improve lipid clearance from the blood compared to traditional fat emulsions used in PN.See study design

What are the potential side effects?

Potential side effects of Omegaven may include allergic reactions (especially if one has fish or egg allergies), bleeding risks when combined with certain drugs like NSAIDs, issues related to blood sugar control such as unstable hyperglycemia, and problems associated with impaired lipid metabolism.

Eligibility Criteria

Inclusion Criteria

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

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I rely on IV nutrition because I can't get enough nutrition by eating and will need it for at least 4 more weeks.

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My direct bilirubin levels are high due to liver issues related to a short gut condition.

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My liver issues are only due to PNALD.

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I have tried all standard treatments for PNALD without success.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ until weaned from pn

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~until weaned from pn

This trial's timeline: 3 weeks for screening, Varies for treatment, and until weaned from pn for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

/Endpoints ( time from baseline until the patient normalizes bilirubin (presents three consecutive direct bilirubin ≤ 2 mg/dL or a direct bilirubin ≤ 2 mg/dL and weaned from PN)

Secondary outcome measures

Essential Fatty Acids (evidence of essential fatty acid (EFA) deficiency)

Growth (weight three times per week, length once weekly, and head circumference)

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: OmegavenExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fish oil

FDA approved

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Carle Foundation HospitalLead Sponsor

6 Previous Clinical Trials

696 Total Patients Enrolled

William Stratton, MDPrincipal InvestigatorCarle Foundation Hospital

Media Library

Omegaven (Omega-3 Fatty Acid Emulsion) Clinical Trial Eligibility Overview. Trial Name: NCT02334293 — N/A

Cholestasis Research Study Groups: Omegaven

Cholestasis Clinical Trial 2023: Omegaven Highlights & Side Effects. Trial Name: NCT02334293 — N/A

Omegaven (Omega-3 Fatty Acid Emulsion) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02334293 — N/A

Frequently Asked Questions

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

How many participants are being recruited to join this clinical trial?

"Unfortunately, this trial is not currently enrolling patients. The data hosted on clinicaltrials.gov indicates it was published on October 1st 2013 and updated last on January 7th 2015. However, 24 other studies are now accepting participants with cholestasis while 10 separate trials are actively searching for people to test the treatment in question."

Answered by AI

Has the efficacy of this treatment been tested in prior clinical investigations?

"Currently, 10 studies are investigating this therapeutic approach with 2 of them in their concluding phase. Of the 14 research sites executing trials for it, Mexico City has a prominent presence."

Answered by AI

Is enrollment for this clinical trial available at the moment?

"Clinicaltrials.gov data suggests that this clinical trial is not presently enrolling patients, as it was last updated in January 2015. Nevertheless, there are 34 other medical studies actively recruiting participants at the moment."

Answered by AI

Is the cut-off age for participation in this medical research 55 years or younger?

"To participate in this research project, individuals must be between 14 days and 4 months old. Moreover, there are 14 opportunities for minors to enroll whereas those over 65 have 24 different studies that they can join."

Answered by AI

Is it possible for me to become a participant in this clinical trial?

"This trial is recruiting 25 cholestasis patients between two weeks and four months of age. Applicants must satisfy the following criteria: they need to be dependent on Parenteral Nutrition (PN) for nutrition, have failed standard therapies for PN Associated Liver Disease, be 14 days old or older, likely survive long-term, and not suffering from other causes of Cholestasis at Omegaven® initiation."

Answered by AI

What general afflictions does this remedy usually combat?

"This treatment is often employed as a nutritional supplement. It has also been used to treat dietary and nutrient deficiencies, pregnancy or postnatal issues, and breast milk production."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Omegaven® as Parenteral Nutrition

2013. "Omegaven® as Parenteral Nutrition". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02334293.

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