Clinical trial NCT01173159: Compassionate Use of Omegaven to Reverse Parenteral Nutrition Induced Cholestasis
Official title: Compassionate Use of a Fish Oil-derived Intravenous Fat Emulsion (Omegaven) to Reverse Parenteral Nutrition (PN) Induced Cholestasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholestasis
Keywords: Parenteral Nutrition
Cholestasis
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2010-07-30
Enrollment: 10
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With a Change in Conjugated/Direct Bilirubin
timeFrame: Completion of Therapy (time frame from 1-14 weeks)
Secondary outcomes:
measure: Number of Participants With a Change in Unconjugated/Total Bilirubin
timeFrame: Completion of Therapy (time frame from 1-14 weeks)
measure: Number of Participants With a Change in Aspartate Transaminase (AST)
timeFrame: Completion of Therapy (time frame from 1-14 weeks)
measure: Number of Participants With a Change in Liver Enzyme (ALT)
timeFrame: Completion of Therapy (time frame from 1-14 weeks)
measure: Number of Participants With a Change in Liver Enzyme Alkaline Phosphatase
timeFrame: Completion of Therapy (time frame from 1-14 weeks)
measure: Number of Participants With a Change in Liver Enzyme Gamma-glutamyltransferase (GGT)
timeFrame: Completion of Therapy (time frame from 1-14 weeks)
measure: Number of Participants With a Change in Triglycerides
timeFrame: Completion of Therapy (time frame from 1-14 weeks)
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Samuel Kocoshis, MD
role: PRINCIPAL_INVESTIGATOR
References: