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Cholestasis Reversal: Efficacy of IV Fish Oil (Reversal)

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ClinicalTrials.gov Identifier: NCT00910104
Recruitment Status : Recruiting
First Posted : May 29, 2009
Last Update Posted : July 9, 2018
Sponsor:
Information provided by (Responsible Party):
Mark Puder, Boston Children’s Hospital

May 20, 2009
May 29, 2009
July 9, 2018
September 2004
September 2020   (Final data collection date for primary outcome measure)
Efficacy of parenteral administration of fish oil derived fat emulsion (Omegaven®) to reverse established parenteral nutrition associated liver disease [ Time Frame: 1 year ]
Efficacy of parenteral administration of fish oil derived fat emulsion (OmegavenTM) to reverse established parenteral nutrition associated liver disease [ Time Frame: 1 year ]
Complete list of historical versions of study NCT00910104 on ClinicalTrials.gov Archive Site
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Cholestasis Reversal: Efficacy of IV Fish Oil
Cholestasis Reversal: Efficacy of IV Fish Oil
The purpose of this study is to determine whether Omegaven is effective in the treatment of parenteral nutrition associated liver disease (PNALD).
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).
Interventional
Phase 2
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Parenteral Nutrition Associated Liver Disease
  • Short Bowel Syndrome
  • Gastrointestinal Disease
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
Experimental: Omegaven
1g/kg/day for duration of study participation for all participants
Intervention: Drug: Omegaven®

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
335
200
September 2020
September 2020   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
up to 17 Years   (Child)
No
Contact: Mark Puder, MD, PhD mark.puder@childrens.harvard.edu
Contact: Kathleen Gura, PharmD kathleen.gura@childrens.harvard.edu
United States
 
 
NCT00910104
05-04-048
1R01FD003460-02 ( U.S. FDA Grant/Contract )
Yes
Not Provided
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Mark Puder, Boston Children’s Hospital
Mark Puder
Not Provided
Not Provided
Boston Children’s Hospital
July 2018

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