Omegaven for Essential Fatty Acid Deficiency

Recruiting in Palo Alto (17 mi)

+4 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Fresenius Kabi

Disqualifiers: Chronic liver disease, Cirrhosis, Transplant, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This study will demonstrate safety in pediatric patients with Parenteral Nutrition-Associated Cholestasis treated with Omegaven®, which is indicated as a source of calories and fatty acids in this patient population

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Omegaven for treating essential fatty acid deficiency?

Research shows that Omegaven, a fish oil-based treatment, has been promising in reversing liver disease and cholestasis (a liver condition) in infants who rely on parenteral nutrition (nutrition given through the veins). However, while it improves certain liver conditions, it may not always improve liver tissue health. ^{1 2 3 4 5}

Is Omegaven safe for use in humans?

Omegaven, a fish oil-based fat emulsion, has been used safely in infants and children with liver disease related to parenteral nutrition, showing benefits like reduced liver damage and improved liver function. It is considered less harmful to the liver compared to traditional soybean oil emulsions, but monitoring for potential side effects is recommended. ^{1 5 6 7 8}

How does the drug Omegaven differ from other treatments for essential fatty acid deficiency?

Omegaven is unique because it is a fish oil-based lipid emulsion rich in omega-3 fatty acids, unlike standard treatments that typically use omega-6 fatty acids. This composition may offer benefits in managing liver-related complications, as seen in conditions like pediatric short bowel syndrome and intestinal failure-associated liver disease. ^{2 7 9 10 11}

Research Team

Eligibility Criteria

This trial is for pediatric patients under 18 with Parenteral Nutrition-Associated Cholestasis (PNAC), which means they have high bilirubin levels and liver issues without other known causes. They must need Omegaven treatment for at least eight weeks and cannot tolerate oral or enteral feeding due to gastrointestinal disorders.

Inclusion Criteria

My parent or guardian has signed the consent form for me.

My child has PNAC and needs Omegaven treatment for at least 8 weeks.

I cannot eat or digest food normally and need nutrition through IV.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Omegaven treatment for Parenteral Nutrition-Associated Cholestasis

56 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Omegaven® (Omega-3 Fatty Acid)

Trial Overview The study tests the safety of using Omegaven®, a fish oil-based emulsion, as a calorie and fatty acid source in children with PNAC who require long-term parenteral nutrition.

Participant Groups

Group I: Single arm OMEGAVEN® (fish oil triglycerides; injectable emulsion) Experimental Treatment 1 Intervention

The dose of investigational drug (study treatment), as well as all other components of the overall nutritional regimen is solely at the discretion of the Investigator. It is assumed the Investigator will use sound medical judgement, follow institutional standards of care regarding the nutrition provided to each patient, and review applicable prescribing information indicating the maximum and recommended dose of Omegaven of 1 g/kg/day infused intravenously over 8 to 24 hours as long as the infusion rate does not exceed 1.5 mL/kg/hour.

Omegaven® is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Omegaven for:

• Parenteral Nutrition-Associated Cholestasis (PNAC) in pediatric patients

🇪🇺 Approved in European Union as Omegaven for:

• Total parenteral nutrition, including short bowel syndrome

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of California Los Angeles Los Angeles, CA

Board of Regents of the University of Oklahoma Health Sciences Center Oklahoma City, OK

Baylor College of Medicine Houston Houston, TX

The University of Texas Health Science Center at San Antonio San Antonio, TX

More Trial Locations

Who Is Running the Clinical Trial?

Fresenius Kabi

Lead Sponsor

Trials

83

Patients Recruited

1,138,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of Omegaven in treating parenteral nutrition-associated liver disease. Park, KT., Nespor, C., Kerner, J.[2011]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hepatic explant pathology of pediatric intestinal transplant recipients previously treated with omega-3 fatty acid lipid emulsion. Matsumoto, CS., Kaufman, SS., Island, ER., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review on hepatic explant pathology of pediatric intestinal transplant recipients: Is it time for an oil change? Imseis, E., Rhoads, JM.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Fish oil containing lipid emulsions in critically ill patients: Critical analysis and future perspectives]. Manzanares, W., Langlois, PL.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Failure of resolution of portal fibrosis during omega-3 fatty acid lipid emulsion therapy in two patients with irreversible intestinal failure. Soden, JS., Lovell, MA., Brown, K., et al.[2011]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Fish Oil Intravenous Lipid Emulsions as Monotherapy in the Pediatric Intestinal Failure Patient: Beyond the Package Insert. Gura, KM., Calkins, KL., Puder, M.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intestinal Hypoganglionosis Leading to Intestinal Failure and the Compassionate Use of Omegaven™. Khalaf, R., Karjoo, S., Danielson, P., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The molecular impact of omega 3 fatty acids on hepatic pro-inflammatory cytokine signaling. Ventro, GJ., Yang, Y., Chen, M., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changing the paradigm: omegaven for the treatment of liver failure in pediatric short bowel syndrome. Diamond, IR., Sterescu, A., Pencharz, PB., et al.[2009]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fatty acid content of marine oil capsules. Chee, KM., Gong, JX., Rees, DM., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fish oil and the management of hypertriglyceridemia. Mattar, M., Obeid, O.[2017]

References

1. United States pubmed.ncbi.nlm.nih.gov

The use of Omegaven in treating parenteral nutrition-associated liver disease. [2011]

2. United States pubmed.ncbi.nlm.nih.gov

Hepatic explant pathology of pediatric intestinal transplant recipients previously treated with omega-3 fatty acid lipid emulsion. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Review on hepatic explant pathology of pediatric intestinal transplant recipients: Is it time for an oil change? [2018]

4. Spain pubmed.ncbi.nlm.nih.gov

[Fish oil containing lipid emulsions in critically ill patients: Critical analysis and future perspectives]. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Failure of resolution of portal fibrosis during omega-3 fatty acid lipid emulsion therapy in two patients with irreversible intestinal failure. [2011]

6. United States pubmed.ncbi.nlm.nih.gov

Use of Fish Oil Intravenous Lipid Emulsions as Monotherapy in the Pediatric Intestinal Failure Patient: Beyond the Package Insert. [2020]

7. Korea (South) pubmed.ncbi.nlm.nih.gov

Intestinal Hypoganglionosis Leading to Intestinal Failure and the Compassionate Use of Omegaven™. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

The molecular impact of omega 3 fatty acids on hepatic pro-inflammatory cytokine signaling. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Changing the paradigm: omegaven for the treatment of liver failure in pediatric short bowel syndrome. [2009]

10. United States pubmed.ncbi.nlm.nih.gov

Fatty acid content of marine oil capsules. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Fish oil and the management of hypertriglyceridemia. [2017]