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Cholestasis Reversal: Efficacy of IV Fish Oil (Reversal)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00910104
Recruitment Status : Completed
First Posted : May 29, 2009
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
Mark Puder, Boston Children’s Hospital

Brief Summary:
The purpose of this study is to determine whether Omegaven is effective in the treatment of parenteral nutrition associated liver disease (PNALD).

Condition or disease Intervention/treatment Phase
Parenteral Nutrition Associated Liver Disease Short Bowel Syndrome Gastrointestinal Disease Drug: Omegaven® Phase 2 Phase 3

Detailed Description:
The purpose of this study is to determine whether the omega-3 fatty acid emulsion (Omegaven), when used in lieu of the conventional soy-based fat emulsion (Intralipid), is effective in the treatment of parenteral nutrition associated liver disease (PNALD).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 290 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cholestasis Reversal: Efficacy of IV Fish Oil
Actual Study Start Date : September 2004
Actual Primary Completion Date : January 23, 2019
Actual Study Completion Date : January 23, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases

Arm Intervention/treatment
Experimental: Omegaven
1g/kg/day for duration of study participation for all participants
Drug: Omegaven®
10% Omegaven® 1g/kg/day, IV (in the vein) until the patient no longer requires parenteral nutrition or until participation in the study is terminated




Primary Outcome Measures :
  1. Efficacy of parenteral administration of fish oil derived fat emulsion (Omegaven®) to reverse established parenteral nutrition associated liver disease [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients will be PN dependent (unable to meet nutritional needs solely by enteral nutrition) and are expected to require PN for at least another 30 days
  2. Patients considered eligible for study participation must have parenteral nutrition associated liver disease (PNALD) as defined as a direct bilirubin of > 2 mg/dl or currently on Omegaven through another protocol. Other causes of liver disease should be excluded. A liver biopsy is not necessary for treatment.
  3. Direct bilirubin > 2.0 mg/dl or already on Omegaven through another protocol
  4. Signed patient informed consent.
  5. The patient must have utilized standard therapies to prevent the progression of his/her liver disease including surgical treatment, cyclic PN, avoiding overfeeding, reduction/removal of copper and manganese from PN, advancement of enteral feeding, and the use of ursodiol (i..e., Actigall®).

Exclusion Criteria:

  1. Pregnancy
  2. Other causes of chronic liver disease (Hepatitis C, biliary atresia, and alpha 1 anti-trypsin deficiency).
  3. Enrollment in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team)
  4. The parent or guardian or child unwilling to provide consent or assent

In rare instances, patients diagnosed with PNALD may later be found to have liver disease due to other causes in addition to the use of PN (i.e., inborn errors of metabolism, viral infections ). Such causes may not be known at the time of enrollment and will not preclude them from continuing in the study. For the sake of statistical analysis, however, these patients will be excluded although all data will be collected and reviewed.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00910104


Locations
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United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Mark Puder

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mark Puder, M.D., Ph.D, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT00910104    
Other Study ID Numbers: 05-04-048
1R01FD003460-02 ( U.S. FDA Grant/Contract )
First Posted: May 29, 2009    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019
Keywords provided by Mark Puder, Boston Children’s Hospital:
PNALD
Omegaven
Parenteral Nutrition Associated Liver Disease
Cholestasis
Short Bowel Syndrome
Additional relevant MeSH terms:
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Liver Diseases
Cholestasis
Gastrointestinal Diseases
Short Bowel Syndrome
Digestive System Diseases
Pathologic Processes
Bile Duct Diseases
Biliary Tract Diseases
Malabsorption Syndromes
Intestinal Diseases
Postoperative Complications