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Trial record 21 of 368 for:    Expanded Access Studies

Compassionate Use of Omegaven

Expanded access is currently available for this treatment.
Verified May 2016 by Geisinger Clinic
Information provided by (Responsible Party):
Edward Everett DO, Geisinger Clinic Identifier:
First received: May 18, 2016
Last updated: NA
Last verified: May 2016
History: No changes posted

This expanded access protocol is for children that cannot get enough nutrients from food and must receive nutrition through a vein. The standard nutrition given through a vein is blend that has soybean fat. If this is given over a long period of time, it can cause problems. It can lead to severe and/or permanent injury to the liver.

It is believed that a type of fish oil blend, called Omegaven®, may be used in place of the soybean fat blend. The Omegaven® fish oil blend may greatly reduce the risk of liver injury.

Omegaven® is not approved by the Food and Drug Administration (FDA). It is only offered under an "expanded access" protocol as an alternative to the soybean fat blend.

Condition Intervention
Dietary Supplement: Omegaven

Study Type: Expanded Access     What is Expanded Access?
Official Title: Compassionate Use of an Intravenous Fat Emulsion Comprised of Fish Oil in The Treatment of Parenteral Nutrition Induced Liver Injury in Children

Further study details as provided by Geisinger Clinic:


Ages Eligible for Study:   up to 5 Years   (Child)
Genders Eligible for Study:   Both

Inclusion Criteria:

  1. Male or female
  2. Older than 14 days and less than 5 years of age
  3. Direct bilirubin value is greater than 2 mg/dL
  4. Be expected to require intravenous nutrition for at least an additional 28 days
  5. Parent/legal guardian has agreed to provide consent/parental permission

Exclusion Criteria:

  1. Patients who have a congenitally lethal condition (e.g. Trisomy 13).
  2. Patients who have clinically severe bleeding not able to be managed with routine measures.
  3. Patients who have evidence of a viral hepatitis or primary liver disease as the primary etiology of their cholestasis.
  4. Patients who have other health problems such that survival is extremely unlikely even if the infant's cholestasis improves.

5 The parent/legal guardian is unwilling to provide consent/parental permission.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02778698

Contact: Edward A Everett, DO 570-271-8091
Contact: Anne Russo, MD 570-271-8091

Sponsors and Collaborators
Geisinger Clinic
Principal Investigator: Edward A Everett, DO Geisinger Clinic
  More Information

Responsible Party: Edward Everett DO, Principal Investigator, Geisinger Clinic Identifier: NCT02778698     History of Changes
Other Study ID Numbers: OMEGAVEN 
Study First Received: May 18, 2016
Last Updated: May 18, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
United States: Federal Government

Additional relevant MeSH terms:
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases processed this record on October 25, 2016