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:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-25 @ 4:13 AM
NCT ID:
NCT02925520
Eligibility Criteria:
Inclusion Criteria:
* Greater than 4 weeks (28 days) old and less then 5 years of age
* Diagnosis of PNALD as defined by serum direct bilirubin greater than 2 mg/dL on 2 consecutive occasions
* Expected to require intravenous nutrition for at least an additional 28 days
* Have been PN-dependent for at least four weeks prior to planned Omegaven initiation
* PN-dependent and unable to meet nutritional requirements by enteral means
* Have failed standard therapies to prevent progression of PNALD
* Hospitalized at time of Omegaven initiation
Exclusion Criteria:
* Have a congenitally lethal condition (e.g. Trisomy 13).
* Have evidence of a viral hepatitis or primary liver disease as the primary etiology of their cholestasis.
* Have other health problems such that survival is extremely unlikely even if the infant's cholestasis improves.
* Have been in another clinical trial within 30 days prior to enrollment or received an investigational drug within 30 days prior to enrollment or scheduled to receive an investigational drug other than Omegaven during the study period.
* Severe and/or unstable concomitant systemic disease such as complex congenital cardiac disease, renal failure, autoimmune disease, sepsis, inborn error of metabolism, genetic liver disease
* Bleeding disorder
* Biochemical disturbance with potential of worsening with proposed treatment, e.g. persistent hyperglycemia, hypertriglyceridemia, hypercalcemia.
Sex:
ALL
Minimum Age:
4 Weeks
Maximum Age:
5 Years
Study:
NCT02925520
Study Brief:
Protocol Section:
NCT02925520