Status:
COMPLETED
Compassionate Use of Omegaven to Reverse Parenteral Nutrition Induced Cholestasis
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Conditions:
Cholestasis
Eligibility:
All Genders
1-18 years
Phase:
NA
Brief Summary
The purpose of this research study is to see if giving Omegaven (an intravenous fat emulsion containing fish oil) instead of the current lipid emulsion, which contains fat derived from soybeans, as pa...
Detailed Description
Enrollment of subjects into this study will occur for up to 4 years. Subjects will receive Omegaven at a dose of up to 1 g/kg body weight/day until they no longer require total parenteral nutrition or...
Eligibility Criteria
Inclusion
- Males and females ages one month of age to 18 years of age
- Patients with intestinal failure on TPN
- Patients who have a conjugated/direct bilirubin of ≥3 mg/dl for more than weeks and in whom other causes of cholestasis have been excluded with reasonable certainty utilizing biochemical, serologic, microbiologic, and radiographic techniques. Liver biopsy is not required to rule out other disorders, but may be utilized at the clinician's discretion
- Patients in whom reduction of IV soy-based lipid to an average \<1.2g/kg body weight/day has failed to reduce the conjugated/direct bilirubin within ≥ 30 days of implementation
- Willing to use birth control during study participation for females of child- bearing potential, as determined by investigator.
- Signed informed consent for use of Omegaven® obtained
Exclusion
- Any of the contraindications to use of Omegaven®
- Impaired lipid metabolism (triglycerides \>1000 mg/dL) while on
- 1g/kg/day or less of Intralipid
- History of severe hemorrhagic disorders (ie. hemophilia, Von Willebrand disease, etc.)
- Unstable diabetes mellitus
- Collapse and shock
- Stroke/ Embolism
- Cardiac infarction within the last 3 months
- Undefined coma status
- Pregnancy (positive pregnancy test) prior to enrollment in the study for females of child-bearing potential
- Females of child-bearing potential who are unwilling to use birth control during study participation
- Parental decision to forego the use of Omegaven®
- Known fish or egg allergy
- Pregnancy
- Causes of liver disease other than Parenteral Nutrition Associated Cholestasis
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01173159
Start Date
July 1 2010
End Date
December 1 2018
Last Update
June 17 2020
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229