Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2025-12-24 @ 9:57 PM
NCT ID:
NCT00969332
Eligibility Criteria:
Inclusion Criteria:
* Clinical evidence of parenteral nutrition associated cholestasis
* Direct bilirubin greater or equal to 2 mg/dL on 2 consecutive measurements
* Expected parenteral nutrition course greater than 30 days
* Acquired or congenital gastrointestinal disease
* \> 2 weeks of age and \< 18 years of age
* \> 60% calories from parenteral nutrition
* Failed standard therapies to prevent progression of liver disease (Actigal, cyclic parenteral nutrition, avoidance of overfeeding, reduction/removal of copper from parenteral nutrition if elevated my laboratory analysis, advancement of enteral feeds)
Exclusion Criteria:
* Inborn errors of metabolism
* Extracorporeal Membrane Oxygenation
* Seafood, egg, or Omegaven allergy
* Documented case of liver disease other than Parenteral Nutrition Associated Cholestasis
* Hemorrhagic disorder
* Anticoagulant therapy
* Hemodynamically unstable or in shock
* Comatose state
* Stroke, pulmonary embolism, recent myocardial infarction
* Diabetes
* Fatal chromosomal disorder
* Enrollment in any other clinical trial involving an investigational agent
* Patient, parent, or legal guardians unable or unwilling to give consent
* Patient expected to be weaned from parenteral nutrition in 30 days
* unable to tolerate necessary monitoring
* Patient requiring aspirin or toradel or motrin
* Patient requiring dialysis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Weeks
Maximum Age:
18 Years
Study:
NCT00969332
Study Brief:
Protocol Section:
NCT00969332