ClinicalTrials.gov
ClinicalTrials.gov Menu

Omegaven Expanded Access Protocol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02121769
Expanded Access Status : Available
First Posted : April 24, 2014
Last Update Posted : October 10, 2017
Sponsor:
Information provided by (Responsible Party):
Tyler Burpee, MD, St. Luke’s Health System, Boise, Idaho

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.

Condition or disease Intervention/treatment
Parenteral Nutrition Associated Liver Disease Drug: Omegaven

Study Type : Expanded Access
Official Title: Protocol for Patients With Parenteral Nutrition Associated Liver Disease (PNALD) to Access Parenteral Fish Oil (Omegaven®) - Omegaven IND 122375



Intervention Details:
  • Drug: Omegaven
    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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02121769


Contacts
Contact: Allyson Reynolds, NP 208-381-7370 renolal@slhs.org

Locations
United States, Idaho
St. Luke's Pediatric Gastroenterology
Boise, Idaho, United States, 83712
Contact: Allyson Reynolds, NP    208-381-7370    renolal@slhs.org   
Principal Investigator: Tyler Burpee, MD         
Sponsors and Collaborators
St. Luke’s Health System, Boise, Idaho
Investigators
Principal Investigator: Tyler Burpee, MD Pediatric Gastroenterology

Responsible Party: Tyler Burpee, MD, Principal Investigator, St. Luke’s Health System, Boise, Idaho
ClinicalTrials.gov Identifier: NCT02121769     History of Changes
Other Study ID Numbers: Omegaven Expanded Access
First Posted: April 24, 2014    Key Record Dates
Last Update Posted: October 10, 2017
Last Verified: October 2017

Keywords provided by Tyler Burpee, MD, St. Luke’s Health System, Boise, Idaho:
cholestasis
short bowel syndrome

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases