Cholestasis Reversal: Efficacy of IV Fish Oil

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Children's Hospital Boston
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00910104
First received: May 20, 2009
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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


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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cholestasis Reversal: Efficacy of IV Fish Oil

Resource links provided by NLM:


Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • Efficacy of parenteral administration of fish oil derived fat emulsion (Omegaven®) to reverse established parenteral nutrition associated liver disease [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: September 2004
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: September 2020 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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).

  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
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 U>U 2 mg/dl or by histology and/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, have PNALD by histology, 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, Cystic fibrosis, 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.

  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: NCT00910104

Contacts
Contact: Mark Puder, MD, PhD mark.puder@childrens.harvard.edu
Contact: Kathleen Gura, PharmD kathleen.gura@childrens.harvard.edu

Locations
United States, Massachusetts
Children's Hospital Boston Recruiting
Boston, Massachusetts, United States, 02115
Contact: Mark Puder, MD, PhD       mark.puder@childrens.harvard.edu   
Contact: Kathleen Gura, PharmD       kathleen.gura@childrens.harvard.edu   
Principal Investigator: Mark Puder, MD, PhD         
Principal Investigator: Kathleen M Gura, PharmD         
Sub-Investigator: Tom Jaksic, MD, PhD         
Sub-Investigator: Christopher P Duggan, MD, PhD         
Sponsors and Collaborators
Children's Hospital Boston
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT00910104     History of Changes
Other Study ID Numbers: 05-04-048, 1 R01 FD 003460-02
Study First Received: May 20, 2009
Last Updated: July 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Hospital Boston:
PNALD
Omegaven
Parenteral Nutrition Associated Liver Disease
Cholestasis
Short Bowel Syndrome

Additional relevant MeSH terms:
Malabsorption Syndromes
Cholestasis
Gastrointestinal Diseases
Digestive System Diseases
Liver Diseases
Short Bowel Syndrome
Bile Duct Diseases
Biliary Tract Diseases
Intestinal Diseases
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on August 21, 2014