Compassionate Use of Omegaven to Reverse Parenteral Nutrition Induced Cholestasis

Completed · Not applicable

Conditions studied: Cholestasis

In brief

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 part of your child's intravenous (IV) nutrition therapy may be tolerated better. It may reduce the harmful effects to the liver, may stop any further liver damage and may reverse damage already done to the liver because of the prolonged use of nutrition through your child's IV.

Key facts

Study ID

NCT01173159

Run by

Children's Hospital Medical Center, Cincinnati

People needed

10

Starts

2010-07-01

Expected to finish

2018-12-01

Last updated by the study team

2020-06-17

Who can join

Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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