Compassionate Use of Omegaven IV Fat Emulsion

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by North Shore Long Island Jewish Health System
Sponsor:
Information provided by (Responsible Party):
Cindy Haller, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT00816348
First received: December 31, 2008
Last updated: July 1, 2013
Last verified: July 2013
  Purpose

This is a compassionate use protocol to use intravenous fish oil infusion, Omegaven®, to infants and children with parenteral nutrition-associated liver disease to enable reversal of elevated serum liver enzymes and direct bilirubin (cholestasis).


Condition Intervention Phase
Cholestasis
Parenteral Nutrition Associated Liver Disease
Drug: Omegaven
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Compassionate Use of Omegaven IV Fat Emulsion

Resource links provided by NLM:


Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • Decline in serum direct bilirubin levels below 2 on two serial measures. [ Time Frame: Biweekly X 4, then monthly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improving liver function tests. [ Time Frame: Biweekly X 4, then monthly ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: December 2008
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Omegaven
    Omegaven® will be initiated at a dose of 0.5 gram/kg/day and is infused over 24 hours for 1-2 days, and then advanced to 1 gram/kg/day. Omegaven® will be infused intravenously through either a central or peripheral catheter alone or in conjunction with parenteral nutrition. Omegaven® will continue until weaned from PN. Monotherapy with Omegaven® can continue as an additional source of calories after the dextrose/protein portion of PN is discontinued. Omegaven may be restarted within seven days of discontinuing therapy. After seven days, and meeting inclusion criteria, Omegaven can resume at the initial dose of 0.5 grams/kg/day, advancing to 1 gm/kg/day.
Detailed Description:

Intravenous lipids are necessary in PN (parenteral nutrition) dependent patients due to their high caloric value and essential fatty acid content. However, parenteral fat emulsions composed of soybean oils (omega 6 fatty acids) have been implicated in predisposing patients to PN associated liver disease.

It is hypothesized that by administering Omegaven®, comprised of fish oil (omega 3 fatty acids) in place of conventional soybean fat emulsion, the progression of PN-associated cholestasis may be prevented or reversed.

  Eligibility

Ages Eligible for Study:   up to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Two consecutive direct bilirubin levels of 2 mg/dl or more in a parenteral nutrition dependent infant or child (unable to meet nutritional needs solely by enteral nutrition)
  • Other causes of liver disease have been excluded. A liver biopsy is not necessary for treatment.
  • The patient must have utilized standard therapies to prevent the progression of the liver disease including reduction/removal of copper and manganese from daily PN, trial of enteral feeding if possible, and the use of ursodiol (i.e., Actigall®).

Exclusion Criteria:

  • Documented causes of chronic liver disease other than parenteral nutrition associated liver disease
  • Proven severe advanced liver disease including cirrhosis on biopsy, varices, ascites.
  • An allergy to any seafood product, egg protein, and/or previous allergy to Omegaven®
  • Active coagulopathy characterized by ongoing bleeding or by a requirement for clotting factor replacement (e.g. fresh frozen plasma or cryoprecipitate) to maintain homeostasis
  • Impaired lipid metabolism or severe hyperlipidemia with or without pancreatitis
  • Unstable diabetes mellitus or hyperglycemia
  • Stroke, embolism, collapse and shock, recent MI
  • Cholestasis due to any reason other than parenteral associated liver disease
  • Active new infection at time of initiation of Omegaven®
  • Hemodynamic instability
  • The patient may not be enrolled in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00816348

Contacts
Contact: Cindy Haller, MD (516) 472-3650 challer@nshs.edu
Contact: Kathy Grancher, BS (516) 472-3691 kgranche@nshs.edu

Locations
United States, New York
Cohen Children's Medical Cenetr of New York at North Shore Recruiting
Manhasset, New York, United States, 11030
Contact: Cindy Haller, MD    516-472-3650    challer@nshs.edu   
Contact: Kathy Grancher, BS    (516) 472-3691    kgranche@nshs.edu   
Principal Investigator: Cindy Haller, MD         
Cohen Children's Medical Center of New York Recruiting
New Hyde Park, New York, United States, 11040
Contact: Cindy Haller, MD    516-472-3650    challer@nshs.edu   
Contact: Kathy Grancher, BS    (516) 47203691    kgranche@nshs.edu   
Principal Investigator: Cindy Haller, MD         
Sponsors and Collaborators
Cindy Haller
Investigators
Principal Investigator: Cindy Haller, MD Cohen Children's Medical Center of New York
  More Information

No publications provided

Responsible Party: Cindy Haller, Physician, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT00816348     History of Changes
Other Study ID Numbers: 08-204
Study First Received: December 31, 2008
Last Updated: July 1, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by North Shore Long Island Jewish Health System:
Cholestasis
Parenteral Nutrition Associated Liver Disease

Additional relevant MeSH terms:
Cholestasis
Liver Diseases
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 28, 2014