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Omegaven Expanded Access Protocol

Primary Purpose

Parenteral Nutrition Associated Liver Disease

Status

No longer available

Phase

Locations

United States

Study Type

Expanded Access

Intervention

Omegaven

About this trial

This is an expanded access trial for Parenteral Nutrition Associated Liver Disease focused on measuring cholestasis, short bowel syndrome

Eligibility Criteria

undefined - 17 Years (Child)All Sexes

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
Parenteral nutrition associated liver disease (PNALD) as defined as a direct bilirubin of ≥ 2 mg/dL on the last two consecutive bilirubins while on PN. Other causes of liver disease should be excluded. A liver biopsy is not necessary for treatment.
Failed standard/conventional therapies to prevent progression of PNALD.
Age newborn to 17 years of age
Signed informed consent.

Exclusion Criteria:

Allergy to eggs and/or shellfish
Female who is pregnant or lactating
Severe hemorrhagic disorder
Other causes of chronic liver disease (Hepatitis C, Cystic fibrosis, biliary atresia, and alpha 1 anti-trypsin deficiency,)
18 years of age or older
Parent/legally authorized representative is unwilling to consent.

Sites / Locations

St. Luke's Pediatric Gastroenterology

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT02121769

First Posted

April 21, 2014

Last Updated

April 8, 2019

Sponsor

St. Luke's Health System, Boise, Idaho

1. Study Identification

Unique Protocol Identification Number

NCT02121769

Brief Title

Omegaven Expanded Access Protocol

Official Title

Protocol for Patients With Parenteral Nutrition Associated Liver Disease (PNALD) to Access Parenteral Fish Oil (Omegaven®) - Omegaven IND 122375

Study Type

Expanded Access

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

No longer available

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

St. Luke's Health System, Boise, Idaho

4. Oversight

5. Study Description

Brief Summary

Omegaven is an intravenous fat emulsion (IFE) comprised of omega-3 fatty acids derived from fish oil. It will be used in an open label compassionate use treatment protocol, as an alternative to soybean oil (omega-6), as the sole IFE source of parenteral nutrition in an effort to reduce and/or reverse parenteral nutrition associated liver disease. The study will evaluate the safety and efficacy of Omegaven use in pediatric patients with PN dependence and PNALD.

6. Conditions and Keywords

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

Parenteral Nutrition Associated Liver Disease

Keywords

cholestasis, short bowel syndrome

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Omegaven

Intervention Description

10% Omegaven 1g/kg/day, Intravenous by continuous infusion in conjunction with parenteral nutrition, until the patient no longer requires parenteral nutrition or until participation in the study is terminated.

10. Eligibility

Sex

All

Maximum Age & Unit of Time

17 Years

Eligibility Criteria

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 Parenteral nutrition associated liver disease (PNALD) as defined as a direct bilirubin of ≥ 2 mg/dL on the last two consecutive bilirubins while on PN. Other causes of liver disease should be excluded. A liver biopsy is not necessary for treatment. Failed standard/conventional therapies to prevent progression of PNALD. Age newborn to 17 years of age Signed informed consent. Exclusion Criteria: Allergy to eggs and/or shellfish Female who is pregnant or lactating Severe hemorrhagic disorder Other causes of chronic liver disease (Hepatitis C, Cystic fibrosis, biliary atresia, and alpha 1 anti-trypsin deficiency,) 18 years of age or older Parent/legally authorized representative is unwilling to consent.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tyler Burpee, MD

Organizational Affiliation

Pediatric Gastroenterology

Official's Role

Principal Investigator

Facility Information:

Facility Name

St. Luke's Pediatric Gastroenterology

City

Boise

State/Province

Idaho

ZIP/Postal Code

83712

Country

United States

12. IPD Sharing Statement

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Omegaven Expanded Access Protocol

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