Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Omegaven Treatment of Parenteral Nutrition (PN) Induced Liver Injury

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Children's Hospital Los Angeles.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Children's Hospital Los Angeles
ClinicalTrials.gov Identifier:
NCT01089426
First received: March 15, 2010
Last updated: July 22, 2011
Last verified: July 2011

March 15, 2010
July 22, 2011
September 2008
July 2013   (final data collection date for primary outcome measure)
Rate of reduction of direct bilirubin [ Time Frame: normalization of direct bilirubin: an expected average of approximately 5 months ] [ Designated as safety issue: No ]
Rate of reduction of direct bilirubin [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01089426 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Omegaven Treatment of Parenteral Nutrition (PN) Induced Liver Injury
Research Study of an Intravenous Fat Emulsion Comprised of Fish Oils (Omegaven) in the Treatment of Parenteral Nutrition (PN) Induced Liver Injury

This study examines the hypothesis that administering intravenous fish oil, in lieu of intravenous soybean oil, can ameliorate the progression of PN-associated cholestatic liver disease in pediatric patients with elevated direct bilirubin requiring PN for more than 30 days.

In the United States, patients dependent upon parenteral nutrition (PN) receive parenteral fat emulsions composed of soybean oils. Lipids are necessary in PN dependent patients due to their high caloric value and essential fatty acid content. They have been implicated in predisposing patients to PN associated liver disease. Phytosterols such as those contained in soybean oils are thought to have a deleterious effect on biliary secretion.

Children requiring prolonged PN are at risk for developing PN associated liver disease. We hypothesize that although omega-6 fatty acid emulsions prevent fatty acid deficiency, they are not cleared in a manner similar to enteral chylomicrons and therefore accumulate in the liver and resulting in steatotic liver injury. We further hypothesize that a fat emulsion comprised of omega-3 fatty acids (i.e., fish oil) such as Omegaven™ would be beneficial in the management of steatotic liver injury by its inhibition of de novo lipogenesis, the reduction of arachidonic acid-derived inflammatory mediators, prevention of essential fatty acid deficiency through the presence of small amounts of arachidonic acid, and improved clearance of lipids from the serum. Animal studies have shown that IV fat emulsions (IFE) such as fish oil that are high in eicosapentaenic and docashexaaenoic acid reduce impairment of bile flow which is seen in cholestasis caused by conventional fat emulsions. Intravenous omega three fatty acids may be well tolerated and might reduce the inflammatory effect in the liver of prolonged PN exposure and could potentially reverse any hepatic dysfunction due to PN/IFE use. By administering Omegaven™ in place of conventional phytosterol/soybean fat emulsions we may reverse or prevent the progression of PN associated cholestasis and thus allow the patient to be maintained on adequate PN until they are able to ingest adequate nutrition enterally.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Liver Injury
  • Drug: Omegaven™
    1 g/kg/d of Omegaven until discontinuation of PN
    Other Name: Highly refined fish oil for intravenous administration (10% Omegaven™)
  • Other: Historical Controls
    Standard of Care
  • Historical controls
    A subset of patients previously seen, who have had at least 2 consecutive direct bilirubin levels > 2 mg/dL, who depended on parenteral nutrition for at least 90 days after surgical therapy for congenital or acquired intestinal diseases
    Intervention: Other: Historical Controls
  • Experimental: Omegaven™
    Intervention: Drug: Omegaven™

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
Not Provided
July 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients will be parenteral nutrition dependent and are expected to require PN for at least another 30 days
  • Patients must have parenteral nutrition associated liver disease (PNALD) as defined by having at least 2 consecutive direct bilirubins >2 mg/dl.

Exclusion Criteria:

  • Pregnancy
  • Other causes of liver disease
  • Enrollment in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team)
  • Direct bilirubin < 2 mg/dl
  • Allergy to any fish product, egg protein, and/or previous allergy to Omegaven
  • Active coagulopathy characterized by on-going bleeding or acute need for clotting factor replacement such as FFP or cryoprecipitate to maintain homeostasis
  • Impaired lipid metabolism as defined by serum Tg level >400 at time of initiation of Omegaven
  • Unstable diabetes mellitus
  • Recent stroke/embolism, not including catheter related thrombosis, which is a common complication of central venous catheter.
  • Collapse and shock
  • Undefined coma status
  • Untreated infection at time of initiation of Omegaven
  • Hemodynamic instability
  • > 21 years of age
Both
up to 21 Years
No
Contact: Russell Merritt, M.D., PhD (323) 361-2181
Contact: Pui Yan, MSCR (323) 361-8631 pyan@chla.usc.edu
United States
 
NCT01089426
CCI-08-00127
Yes
Russell J. Merritt, MD, PhD, Intestinal Rehabilitation, GI Division, Childrens Hospital Los Angeles
Children's Hospital Los Angeles
Not Provided
Principal Investigator: Russell Merritt, M.D., PhD Children's Hospital Los Angeles
Children's Hospital Los Angeles
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP