Evaluation of Omegaven™ Parenteral Nutrition in Patients With Total Parenteral Nutrition (TPN)-Induced Cholestasis

NCT00826020 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 0084-09-FB
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if established parenteral nutrition (PN) associated liver disease can be reversed or its progression halted by using a parenteral fat emulsion prepared from fish oil as measured by normalization of serum levels of hepatic enzymes and bilirubin.

Conditions

Parenteral Nutrition Associated Liver Disease PNALD; Cholestasis

Keywords

PN; parenteral nutrition; fat emulsions; omega-6 fatty acid; liver disease; fatty acid deficiency

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Progression to Small Bowel Transplantation.

  Whether or not the subject had an intestine-containing transplant or not

  Bi-weekly x4, then monthly until the completion of the study, for an overall average of 5.5 years follow-up for the cohort

Secondary Outcomes (1)

• Number of Subjects With Reversal of Biochemical Cholestasis

  weekly x 4, then bi-weekly x4, then monthly until the completion of the study, with an average follow-up of 5.5 years for the study cohort

Study Arms (1)

Omegaven™

EXPERIMENTAL

This study will be a prospective, non-randomized, open-label study of Omegaven™ for provision of parenteral lipid calories. The study cohort, receiving the parenteral nutrition (PN) lipid at 1g/kg/day, will be compared to historical controls at University of Nebraska Medical Center (UNMC) where parenteral lipid calories were provided exclusively through soybean-based formulations. The study is planned to enroll 100 patients. The Intestinal Rehabilitation Program at UNMC sees between 20 and 30 new pediatric patients per year, with almost all being PN-dependent and over 75% presenting with a bilirubin ≥ 2mg/dL. Based on these calculations, we estimate 4-5 years to enroll 100 patients.

Drug: Omegaven™

Interventions

Omegaven™ DRUG

10% Omegaven™, 50 or 100 mL bottle; 1gram/kg/day and is infused over 12-24 hours.

Also known as: Omega-3 fat emulsion

Omegaven™

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be enrolled in the Intestinal Rehabilitation Program at the University of Nebraska Medical Center, AND:
• Be unable to meet nutritional needs solely by enteral nutrition and be expected to require PN for at least another 30 days
• Have clinical evidence of parenteral nutrition associated liver disease (PNALD) as defined as a direct bilirubin of 2 mg/dl or more. A liver biopsy is desirable but not necessary for treatment
• Signed patient informed consent

You may not qualify if:

• Parent or guardian or child unwilling to provide consent or assent
• Inability or unwillingness on the part of parent/guardian or child to follow clinical recommendations of the Intestinal Rehabilitation Program
• Allergies or clinical conditions precluding safe use of Omegaven™

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68105, United States

Location

Related Publications (6)

• Alwayn IP, Gura K, Nose V, Zausche B, Javid P, Garza J, Verbesey J, Voss S, Ollero M, Andersson C, Bistrian B, Folkman J, Puder M. Omega-3 fatty acid supplementation prevents hepatic steatosis in a murine model of nonalcoholic fatty liver disease. Pediatr Res. 2005 Mar;57(3):445-52. doi: 10.1203/01.PDR.0000153672.43030.75. Epub 2005 Jan 19.

  PMID: 15659701 BACKGROUND

• Van Aerde JE, Duerksen DR, Gramlich L, Meddings JB, Chan G, Thomson AB, Clandinin MT. Intravenous fish oil emulsion attenuates total parenteral nutrition-induced cholestasis in newborn piglets. Pediatr Res. 1999 Feb;45(2):202-8. doi: 10.1203/00006450-199902000-00008.

  PMID: 10022591 BACKGROUND

• Gura KM, Parsons SK, Bechard LJ, Henderson T, Dorsey M, Phipatanakul W, Duggan C, Puder M, Lenders C. Use of a fish oil-based lipid emulsion to treat essential fatty acid deficiency in a soy allergic patient receiving parenteral nutrition. Clin Nutr. 2005 Oct;24(5):839-47. doi: 10.1016/j.clnu.2005.05.020.

  PMID: 16029913 BACKGROUND

• Gura KM, Lee S, Valim C, Zhou J, Kim S, Modi BP, Arsenault DA, Strijbosch RA, Lopes S, Duggan C, Puder M. Safety and efficacy of a fish-oil-based fat emulsion in the treatment of parenteral nutrition-associated liver disease. Pediatrics. 2008 Mar;121(3):e678-86. doi: 10.1542/peds.2007-2248.

  PMID: 18310188 BACKGROUND

• Diamond IR, Sterescu A, Pencharz PB, Kim JH, Wales PW. Changing the paradigm: omegaven for the treatment of liver failure in pediatric short bowel syndrome. J Pediatr Gastroenterol Nutr. 2009 Feb;48(2):209-15. doi: 10.1097/MPG.0b013e318182c8f6.

  PMID: 19179884 BACKGROUND

• Mercer DF, Hobson BD, Fischer RT, Talmon GA, Perry DA, Gerhardt BK, Grant WJ, Botha JF, Langnas AN, Quiros-Tejeira RE. Hepatic fibrosis persists and progresses despite biochemical improvement in children treated with intravenous fish oil emulsion. J Pediatr Gastroenterol Nutr. 2013 Apr;56(4):364-9. doi: 10.1097/MPG.0b013e31827e208c.

  PMID: 23201707 DERIVED

MeSH Terms

Conditions

Cholestasis; Hyperphagia; Liver Diseases

Interventions

fish oil triglycerides

Condition Hierarchy (Ancestors)

Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: David Mercer
• Organization: University of Nebraska Medical Center

dmercer@unmc.edu

402-559-6955

Study Officials

• David F Mercer, MD, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2009
• First Posted: January 21, 2009
• Study Start: May 1, 2009
• Primary Completion: October 6, 2017
• Study Completion: October 6, 2017
• Last Updated: October 5, 2023
• Results First Posted: October 28, 2019

Record last verified: 2023-09

Locations

US (1)