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 @ 2:55 PM
Ignite Modification Date:
2025-12-24 @ 2:55 PM
NCT ID:
NCT01173159
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Month
Maximum Age:
18 Years
Study:
NCT01173159
Study Brief:
Protocol Section:
NCT01173159