Compassionate Use of Omegaven IV Fat Emulsion
This study is currently recruiting participants.
Verified July 2011 by North Shore Long Island Jewish Health System
Sponsor:
North Shore Long Island Jewish Health System
Information provided by:
North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT00816348
First received: December 31, 2008
Last updated: July 22, 2011
Last verified: July 2011
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Purpose
This is a compassionate use protocol to use intravenous fish oil infusion, Omegaven®, to infants and children with parenteral nutrition-associated liver disease to enable reversal of elevated serum liver enzymes and direct bilirubin (cholestasis).
| Condition | Intervention | Phase |
|---|---|---|
|
Cholestasis Parenteral Nutrition Associated Liver Disease |
Drug: Omegaven |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Compassionate Use of Omegaven IV Fat Emulsion |
Resource links provided by NLM:
Further study details as provided by North Shore Long Island Jewish Health System:
Primary Outcome Measures:
- Decline in serum direct bilirubin levels below 2 on two serial measures. [ Time Frame: Biweekly X 4, then monthly ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Improving liver function tests. [ Time Frame: Biweekly X 4, then monthly ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: Omegaven
Omegaven® will be initiated at a dose of 0.5 gram/kg/day and is infused over 24 hours for 1-2 days, and then advanced to 1 gram/kg/day. Omegaven® will be infused intravenously through either a central or peripheral catheter alone or in conjunction with parenteral nutrition. Omegaven® will continue until weaned from PN. Monotherapy with Omegaven® can continue as an additional source of calories after the dextrose/protein portion of PN is discontinued. Omegaven may be restarted within seven days of discontinuing therapy. After seven days, and meeting inclusion criteria, Omegaven can resume at the initial dose of 0.5 grams/kg/day, advancing to 1 gm/kg/day.
Intravenous lipids are necessary in PN (parenteral nutrition) dependent patients due to their high caloric value and essential fatty acid content. However, parenteral fat emulsions composed of soybean oils (omega 6 fatty acids) have been implicated in predisposing patients to PN associated liver disease.
It is hypothesized that by administering Omegaven®, comprised of fish oil (omega 3 fatty acids) in place of conventional soybean fat emulsion, the progression of PN-associated cholestasis may be prevented or reversed.
Eligibility| Ages Eligible for Study: | up to 5 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Two consecutive direct bilirubin levels of 2 mg/dl or more in a parenteral nutrition dependent infant or child (unable to meet nutritional needs solely by enteral nutrition)
- Other causes of liver disease have been excluded. A liver biopsy is not necessary for treatment.
- The patient must have utilized standard therapies to prevent the progression of the liver disease including reduction/removal of copper and manganese from daily PN, trial of enteral feeding if possible, and the use of ursodiol (i.e., Actigall®).
Exclusion Criteria:
- Documented causes of chronic liver disease other than parenteral nutrition associated liver disease
- Proven severe advanced liver disease including cirrhosis on biopsy, varices, ascites.
- An allergy to any seafood product, egg protein, and/or previous allergy to Omegaven®
- Active coagulopathy characterized by ongoing bleeding or by a requirement for clotting factor replacement (e.g. fresh frozen plasma or cryoprecipitate) to maintain homeostasis
- Impaired lipid metabolism or severe hyperlipidemia with or without pancreatitis
- Unstable diabetes mellitus or hyperglycemia
- Stroke, embolism, collapse and shock, recent MI
- Cholestasis due to any reason other than parenteral associated liver disease
- Active new infection at time of initiation of Omegaven®
- Hemodynamic instability
- The patient may not be enrolled in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00816348
Contacts
| Contact: Richard J Schanler, MD | (516) 562-4665 | Schanler@nshs.edu |
| Contact: Debra C Potak, RN | (516) 562-2205 | Dpotak@nshs.edu |
Locations
| United States, New York | |
| Cohen Children's Medical Cenetr of New York at North Shore | Recruiting |
| Manhasset, New York, United States, 11030 | |
| Contact: Richard J Schanler, MD 516-562-4665 Schanler@nshs.edu | |
| Contact: Debra C Potak, RN (516) 562-2205 Dpotak@nshs.edu | |
| Principal Investigator: Richard J Schanler, MD | |
| Cohen Children's Medical Center of New York | Recruiting |
| New Hyde Park, New York, United States, 11040 | |
| Contact: Richard J Schanler, MD 516-562-4665 Schanler@nshs.edu | |
| Contact: Debra C Potak, RN (516) 562-2205 | |
| Principal Investigator: Richard J Schanler, MD | |
Sponsors and Collaborators
North Shore Long Island Jewish Health System
Investigators
| Principal Investigator: | Richard J Schanler, MD | Cohen Children's Medical Center of New York at North Shore |
More Information
No publications provided
| Responsible Party: | Richard Schanler, MD, Cohen Children's Medical Center of New York at North Shore |
| ClinicalTrials.gov Identifier: | NCT00816348 History of Changes |
| Other Study ID Numbers: | 08-204 |
| Study First Received: | December 31, 2008 |
| Last Updated: | July 22, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by North Shore Long Island Jewish Health System:
|
Cholestasis Parenteral Nutrition Associated Liver Disease |
Additional relevant MeSH terms:
|
Cholestasis Liver Diseases Bile Duct Diseases Biliary Tract Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013