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 @ 4:23 AM
Ignite Modification Date:
2025-12-25 @ 4:23 AM
NCT ID:
NCT00007020
Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Clinical or biochemical evidence of liver disease, unexplained fat-soluble vitamin malabsorption, or peroxisomal dysfunction that compromises bile acid biosynthesis
Inclusion criteria for enrollment were:
* Infants \< age 3 months
* Children presenting for evaluation of cholestasis defined as a conjugated bilirubin \> 2mg/dl or increased serum bile acids
* Older subjects of any age with cholestatic liver disease if urine screens suggested that they had inborn errors of bile acid metabolism
* Confirmation of a diagnosis of an inborn error of bile acid synthesis based upon urine analysis by FAB-MS to determine whether specific abnormalities in bile acid synthesis are indicated
* The patient and/or parent/legal guardian must have signed the written informed consent document before study start.
* The patient must be willing and able to comply with all study assessments and procedures.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00007020
Study Brief:
Protocol Section:
NCT00007020