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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

Must not have

Use of medications with associated risk of bleeding, including nonsteroidal antiinflammatory drugs (NSAIDs)

Unstable hyperglycemia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up until weaned from pn

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking medication that can increase my risk of bleeding.

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My blood sugar levels frequently fluctuate.

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My diabetes is not well-controlled.

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I have experienced a sudden drop in blood pressure leading to shock.

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My blood pressure and heart rate are stable.

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I do not have a new infection as I start Omegaven®.

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I have a bleeding disorder or am currently experiencing unusual bleeding.

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My triglyceride levels are over 1000 mg/dL despite low-dose Intralipid treatment.

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I have a severe bleeding disorder like hemophilia.

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I have had a stroke or blood clot.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

/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 study objectives

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

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