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Compassionate Use of Omegaven IV Fat Emulsion

Primary Purpose

Cholestasis, Total Parenteral Nutrition-induced Cholestasis

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Omegaven

About this trial

This is an interventional treatment trial for Cholestasis focused on measuring Cholestasis, Parenteral Nutrition Associated Liver Disease

Eligibility Criteria

2 Weeks - 5 Years (Child)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Cohen Children's Medical Cenetr of New York at North Shore
Cohen Children's Medical Center of New York

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Omegaven

Arm Description

All subjects will receive Omegaven

Outcomes

Primary Outcome Measures

Level of Bilirubin

measurement of bilirubin level weekly. Available data reported.

Secondary Outcome Measures

Full Information

NCT ID

NCT00816348

First Posted

December 31, 2008

Last Updated

January 30, 2017

Sponsor

Cindy Haller

1. Study Identification

Unique Protocol Identification Number

NCT00816348

Brief Title

Compassionate Use of Omegaven IV Fat Emulsion

Official Title

Compassionate Use of Omegaven IV Fat Emulsion

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Terminated

Study Start Date

December 2008 (undefined)

Primary Completion Date

February 2014 (Actual)

Study Completion Date

February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Cindy Haller

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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).

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cholestasis, Total Parenteral Nutrition-induced Cholestasis

Keywords

Cholestasis, Parenteral Nutrition Associated Liver Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Omegaven

Arm Type

Other

Arm Description

All subjects will receive Omegaven

Intervention Type

Drug

Intervention Name(s)

Omegaven

Intervention Description

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.

Primary Outcome Measure Information:

Title

Level of Bilirubin

Description

measurement of bilirubin level weekly. Available data reported.

Time Frame

week 2, 3,4,and 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Weeks

Maximum Age & Unit of Time

5 Years

Accepts Healthy Volunteers

Eligibility 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cindy Haller, MD

Organizational Affiliation

Cohen Children's Medical Center of New York

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cohen Children's Medical Cenetr of New York at North Shore

City

Manhasset

State/Province

New York

ZIP/Postal Code

11030

Country

United States

Facility Name

Cohen Children's Medical Center of New York

City

New Hyde Park

State/Province

New York

ZIP/Postal Code

11040

Country

United States

12. IPD Sharing Statement

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Compassionate Use of Omegaven IV Fat Emulsion

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