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 @ 11:10 PM
Ignite Modification Date:
2025-12-24 @ 11:10 PM
NCT ID:
NCT02121769
Eligibility Criteria:
Inclusion Criteria:
* Patients will be PN dependent (unable to meet nutritional needs solely by enteral nutrition) and are expected to require PN for at least another 30 days
* Parenteral nutrition associated liver disease (PNALD) as defined as a direct bilirubin of ≥ 2 mg/dL on the last two consecutive bilirubins while on PN. Other causes of liver disease should be excluded. A liver biopsy is not necessary for treatment.
* Failed standard/conventional therapies to prevent progression of PNALD.
* Age newborn to 17 years of age
* Signed informed consent.
Exclusion Criteria:
* Allergy to eggs and/or shellfish
* Female who is pregnant or lactating
* Severe hemorrhagic disorder
* Other causes of chronic liver disease (Hepatitis C, Cystic fibrosis, biliary atresia, and alpha 1 anti-trypsin deficiency,)
* 18 years of age or older
* Parent/legally authorized representative is unwilling to consent.
Sex:
ALL
Maximum Age:
17 Years
Study:
NCT02121769
Study Brief:
Protocol Section:
NCT02121769