NCT02925520

Brief Summary

This is an expanded access study to assess the safety profile and changes in serum direct bilirubin levels in infants with PN associated cholestasis. Eligible patients will receive therapy with Omegaven on an expanded access basis by method of continuous infusion. Omegaven will be infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition. The same standards of care provided to all patients receiving parenteral nutrition solution will be followed.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 6, 2016

Completed
Last Updated

January 10, 2019

Status Verified

January 1, 2019

First QC Date

October 4, 2016

Last Update Submit

January 8, 2019

Conditions

Parenteral Nutrition-Associated Liver Disease

Keywords

Cholestasis

Interventions

OmegavenDRUG

Therapy with Omegaven will be provided at a dose of 1 gm/kg/day infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition. Parenteral fat emulsion (Intralipid) will be administered only if necessary to administer adequate calories during Omegaven therapy. The same standards of care provided to all patients receiving parenteral nutrition solution will be followed. Home Use of Omegaven: The Omegaven dose for home use will be the same as that used while in the hospital: 1 gm/kg/day. As with the inpatient part of the protocol, this is a maximum dose and may be decreased at the discretion of the provider.

Also known as: Fish oil

Eligibility Criteria

Age4 Weeks - 5 Years
Sexall
Age GroupsChild (0-17)

You may qualify if:

  • Greater than 4 weeks (28 days) old and less then 5 years of age
  • Diagnosis of PNALD as defined by serum direct bilirubin greater than 2 mg/dL on 2 consecutive occasions
  • Expected to require intravenous nutrition for at least an additional 28 days
  • Have been PN-dependent for at least four weeks prior to planned Omegaven initiation
  • PN-dependent and unable to meet nutritional requirements by enteral means
  • Have failed standard therapies to prevent progression of PNALD
  • Hospitalized at time of Omegaven initiation

You may not qualify if:

  • Have a congenitally lethal condition (e.g. Trisomy 13).
  • Have evidence of a viral hepatitis or primary liver disease as the primary etiology of their cholestasis.
  • Have other health problems such that survival is extremely unlikely even if the infant's cholestasis improves.
  • Have been in another clinical trial within 30 days prior to enrollment or received an investigational drug within 30 days prior to enrollment or scheduled to receive an investigational drug other than Omegaven during the study period.
  • Severe and/or unstable concomitant systemic disease such as complex congenital cardiac disease, renal failure, autoimmune disease, sepsis, inborn error of metabolism, genetic liver disease
  • Bleeding disorder
  • Biochemical disturbance with potential of worsening with proposed treatment, e.g. persistent hyperglycemia, hypertriglyceridemia, hypercalcemia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cook Children's Medical Center

Fort Worth, Texas, 76104, United States

Location

Related Publications (23)

  • Dudrick SJ, Wilmore DW, Vars HM, Rhoads JE. Long-term total parenteral nutrition with growth, development, and positive nitrogen balance. 1968. Nutr Hosp. 2001 Nov-Dec;16(6):287-92; discussion 286-7. No abstract available.

    PMID: 11845800BACKGROUND

  • Wilmore DW, Dudrick SJ. Growth and development of an infant receiving all nutrients exclusively by vein. JAMA. 1968 Mar 4;203(10):860-4. No abstract available.

    PMID: 4965871BACKGROUND

  • Mullick FG, Moran CA, Ishak KG. Total parenteral nutrition: a histopathologic analysis of the liver changes in 20 children. Mod Pathol. 1994 Feb;7(2):190-4.

    PMID: 8008742BACKGROUND

  • Freund HR. Abnormalities of liver function and hepatic damage associated with total parenteral nutrition. Nutrition. 1991 Jan-Feb;7(1):1-5; discussion 5-6.

    PMID: 1802177BACKGROUND

  • Beath SV, Davies P, Papadopoulou A, Khan AR, Buick RG, Corkery JJ, Gornall P, Booth IW. Parenteral nutrition-related cholestasis in postsurgical neonates: multivariate analysis of risk factors. J Pediatr Surg. 1996 Apr;31(4):604-6. doi: 10.1016/s0022-3468(96)90507-2.

    PMID: 8801324BACKGROUND

  • Greenberg GR, Wolman SL, Christofides ND, Bloom SR, Jeejeebhoy KN. Effect of total parenteral nutrition on gut hormone release in humans. Gastroenterology. 1981 May;80(5 pt 1):988-93. No abstract available.

    PMID: 6781979BACKGROUND

  • Yeh SL, Chen WJ, Huang PC. Effects of L-glutamine on induced hepatosteatosis in rats receiving total parenteral nutrition. J Formos Med Assoc. 1995 Oct;94(10):593-9.

    PMID: 8527958BACKGROUND

  • Kubota A, Yonekura T, Hoki M, Oyanagi H, Kawahara H, Yagi M, Imura K, Iiboshi Y, Wasa K, Kamata S, Okada A. Total parenteral nutrition-associated intrahepatic cholestasis in infants: 25 years' experience. J Pediatr Surg. 2000 Jul;35(7):1049-51. doi: 10.1053/jpsu.2000.7769.

    PMID: 10917294BACKGROUND

  • Moss RL, Das JB, Ansari G, Raffensperger JG. Hepatobiliary dysfunction during total parenteral nutrition is caused by infusate, not the route of administration. J Pediatr Surg. 1993 Mar;28(3):391-6; discussion 396-7. doi: 10.1016/0022-3468(93)90238-g.

    PMID: 8468653BACKGROUND

  • Helms RA, Christensen ML, Mauer EC, Storm MC. Comparison of a pediatric versus standard amino acid formulation in preterm neonates requiring parenteral nutrition. J Pediatr. 1987 Mar;110(3):466-70. doi: 10.1016/s0022-3476(87)80519-x. No abstract available.

    PMID: 3102712BACKGROUND

  • Moss RL, Haynes AL, Pastuszyn A, Glew RH. Methionine infusion reproduces liver injury of parenteral nutrition cholestasis. Pediatr Res. 1999 May;45(5 Pt 1):664-8. doi: 10.1203/00006450-199905010-00009.

    PMID: 10231861BACKGROUND

  • Meehan JJ, Georgeson KE. Prevention of liver failure in parenteral nutrition-dependent children with short bowel syndrome. J Pediatr Surg. 1997 Mar;32(3):473-5. doi: 10.1016/s0022-3468(97)90609-6.

    PMID: 9094021BACKGROUND

  • Whalen GF, Shamberger RC, Perez-Atayde A, Folkman J. A proposed cause for the hepatic dysfunction associated with parenteral nutrition. J Pediatr Surg. 1990 Jun;25(6):622-6. doi: 10.1016/0022-3468(90)90348-d.

    PMID: 2113578BACKGROUND

  • Zamir O, Nussbaum MS, Bhadra S, Subbiah MT, Rafferty JF, Fischer JE. Effect of enteral feeding on hepatic steatosis induced by total parenteral nutrition. JPEN J Parenter Enteral Nutr. 1994 Jan-Feb;18(1):20-5. doi: 10.1177/014860719401800120.

    PMID: 8164298BACKGROUND

  • Kaminski DL, Adams A, Jellinek M. The effect of hyperalimentation on hepatic lipid content and lipogenic enzyme activity in rats and man. Surgery. 1980 Jul;88(1):93-100. No abstract available.

    PMID: 6104363BACKGROUND

  • Hultin M, Carneheim C, Rosenqvist K, Olivecrona T. Intravenous lipid emulsions: removal mechanisms as compared to chylomicrons. J Lipid Res. 1995 Oct;36(10):2174-84.

    PMID: 8576643BACKGROUND

  • Qi K, Al-Haideri M, Seo T, Carpentier YA, Deckelbaum RJ. Effects of particle size on blood clearance and tissue uptake of lipid emulsions with different triglyceride compositions. JPEN J Parenter Enteral Nutr. 2003 Jan-Feb;27(1):58-64. doi: 10.1177/014860710302700158.

    PMID: 12549600BACKGROUND

  • Nestel PJ. Effects of N-3 fatty acids on lipid metabolism. Annu Rev Nutr. 1990;10:149-67. doi: 10.1146/annurev.nu.10.070190.001053. No abstract available.

    PMID: 2200461BACKGROUND

  • Chen WJ, Yeh SL, Huang PC. Effects of fat emulsions with different fatty acid composition on plasma and hepatic lipids in rats receiving total parenteral nutrition. Clin Nutr. 1996 Feb;15(1):24-8. doi: 10.1016/s0261-5614(96)80257-3.

    PMID: 16843991BACKGROUND

  • Yeh SL, Chen WJ, Huang PC. Effects of fish oil and safflower oil emulsions on diet-induced hepatic steatosis in rats receiving total parenteral nutrition. Clin Nutr. 1996 Apr;15(2):80-3. doi: 10.1016/s0261-5614(96)80024-0.

    PMID: 16844003BACKGROUND

  • Kinsella JE, Lokesh B, Broughton S, Whelan J. Dietary polyunsaturated fatty acids and eicosanoids: potential effects on the modulation of inflammatory and immune cells: an overview. Nutrition. 1990 Jan-Feb;6(1):24-44; discussion 59-62. No abstract available.

    PMID: 2135755BACKGROUND

  • 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: 18310188BACKGROUND

  • Strijbosch RA, Lee S, Arsenault DA, Andersson C, Gura KM, Bistrian BR, Puder M. Fish oil prevents essential fatty acid deficiency and enhances growth: clinical and biochemical implications. Metabolism. 2008 May;57(5):698-707. doi: 10.1016/j.metabol.2008.01.008.

    PMID: 18442636BACKGROUND

MeSH Terms

Conditions

Cholestasis

Interventions

fish oil triglyceridesFish Oils

Condition Hierarchy (Ancestors)

Bile Duct DiseasesBiliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

OilsLipids

Study Officials

  • Bankole O Osuntokun, MD, MS

    Cook Children's Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
expanded access
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2016

First Posted

October 6, 2016

Last Updated

January 10, 2019

Record last verified: 2019-01

Locations

US(1)