Compassionate Use of Omegaven to Reverse Parenteral Nutrition Induced Cholestasis

Cincinnati Children's Hospital Medical Center

Status: Completed

Conditions: Cholestasis

Treatments: Drug: Omegaven

Study type: Interventional

Funder types: Other

Identifiers

NCT01173159

2009-2314

Details and patient eligibility

About

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.

Full 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 until their conjugated/direct bilirubin has normalized and their enteral lipid intake is sufficient to discontinue intravenous lipids.

Enrollment: 10 patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

Omegaven

Experimental group

Description:

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 until their conjugated/direct bilirubin has normalized and their enteral lipid intake is sufficient to discontinue intravenous lipids.

Treatment:

Drug: Omegaven