Cholestasis Reversal: Efficacy of IV Fish Oil
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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 |
- Efficacy of parenteral administration of fish oil derived fat emulsion (Omegaven®) to reverse established parenteral nutrition associated liver disease [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 220 |
| Study Start Date: | September 2004 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
-
Drug: Omegaven®
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 |
Inclusion Criteria:
- 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
- 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.
- Direct bilirubin > 2.0 mg/dl, have PNALD by histology, or already on Omegaven through another protocol
- Signed patient informed consent.
- 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:
- Pregnancy
- Other causes of chronic liver disease (Hepatitis C, Cystic fibrosis, biliary atresia, and alpha 1 anti-trypsin deficiency,)
- Enrollment in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team)
- 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| Contact: Mark Puder, MD, PhD | mark.puder@childrens.harvard.edu | |
| Contact: Kathleen Gura, PharmD | kathleen.gura@childrens.harvard.edu |
| 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 | |
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: | April 17, 2013 |
| 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:
|
Cholestasis Gastrointestinal Diseases Digestive System Diseases Liver Diseases Short Bowel Syndrome Bile Duct Diseases |
Biliary Tract Diseases Malabsorption Syndromes Intestinal Diseases Postoperative Complications Pathologic Processes |
ClinicalTrials.gov processed this record on May 22, 2013