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Omega-3 Lipid Therapy

Omegaven Therapy for Cholestasis

Phase 2
Waitlist Available
Led By Terra R Varner, PharmD
Research Sponsored by Amarnath, Rathna, M.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up labwork will be collected at baseline, then weekly for the first month. thereafter, a lipid panel will be collected every 2 months, complete metabolic panel every 2 weeks, and essential fatty acid profile monthly, up to an expected average of 108 weeks
Awards & highlights

Study Summary

This pilot study seeks to demonstrate the efficacy of an intravenous lipid preparation high in omega-3 fatty acids (Omegaven) in the treatment of cholestasis in parenteral nutrition dependent patients with short gut syndrome.

Eligible Conditions
  • Cholestasis
  • Short Bowel Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~labwork will be collected at baseline, then weekly for the first month. thereafter, a lipid panel will be collected every 2 months, complete metabolic panel every 2 weeks, and essential fatty acid profile monthly, up to an expected average of 108 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and labwork will be collected at baseline, then weekly for the first month. thereafter, a lipid panel will be collected every 2 months, complete metabolic panel every 2 weeks, and essential fatty acid profile monthly, up to an expected average of 108 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Improvement of liver dysfunction as measured by time to achieve 50 % decrease in direct bilirubin
Secondary outcome measures
Occurrence of potential adverse side effects
a) Maintenance of nutritional status
c) Resolution of liver dysfunction

Trial Design

1Treatment groups
Experimental Treatment
Group I: Omegaven TherapyExperimental Treatment1 Intervention
After baseline labs, which have been collected no earlier than seven days prior to the initiation of therapy are obtained, therapy with Omegaven will be initiated at a starting dose of 0.5 g/kg/day infused over 12 hours. If tolerated, the dose will be increased to 1 g/kg/day, the goal dose. Omegaven will be infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition.

Find a Location

Who is running the clinical trial?

Amarnath, Rathna, M.D.Lead Sponsor
Terra R Varner, PharmDPrincipal InvestigatorPalmetto Health Children's Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Pediatric Surgery InternationalJournal
The Rationale for the Use of Parenteral Omega-3 Lipids in Children with Short Bowel Syndrome and Liver Disease
Diamond, Ivan R., Anca Sterescu, Paul B. Pencharz, and Paul W. Wales. 2008. “The Rationale for the Use of Parenteral Omega-3 Lipids in Children with Short Bowel Syndrome and Liver Disease”. Pediatric Surgery International. Springer Science and Business Media LLC. doi:10.1007/s00383-008-2174-0.
PediatricsJournal
Reversal of Parenteral Nutrition–associated Liver Disease in Two Infants with Short Bowel Syndrome Using Parenteral Fish Oil: Implications for Future Management
Gura, Kathleen M., Christopher P. Duggan, Sharon B. Collier, Russell W. Jennings, Judah Folkman, Bruce R. Bistrian, and Mark Puder. 2006. “Reversal of Parenteral Nutrition–associated Liver Disease in Two Infants with Short Bowel Syndrome Using Parenteral Fish Oil: Implications for Future Management”. Pediatrics. American Academy of Pediatrics (AAP). doi:10.1542/peds.2005-2662.
Journal of Pediatric SurgeryJournal
Hepatobiliary Dysfunction During Total Parenteral Nutrition Is Caused by Infusate, Not the Route of Administration
Moss, R.Lawrence, John B. Das, Ghaus Ansari, and John G. Raffensperger. 1993. “Hepatobiliary Dysfunction During Total Parenteral Nutrition Is Caused by Infusate, Not the Route of Administration”. Journal of Pediatric Surgery. Elsevier BV. doi:10.1016/0022-3468(93)90238-g.
PediatricsJournal
Safety and Efficacy of a Fish-oil–based Fat Emulsion in the Treatment of Parenteral Nutrition–associated Liver Disease
Gura, Kathleen M., Sang Lee, Clarissa Valim, Jing Zhou, Sendia Kim, Biren P. Modi, Danielle A. Arsenault, et al.. 2008. “Safety and Efficacy of a Fish-oil–based Fat Emulsion in the Treatment of Parenteral Nutrition–associated Liver Disease”. Pediatrics. American Academy of Pediatrics (AAP). doi:10.1542/peds.2007-2248.
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~1 spots leftby Apr 2025
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