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 @ 11:48 PM
Ignite Modification Date:
2025-12-24 @ 11:48 PM
NCT ID:
NCT02922751
Eligibility Criteria:
Inclusion Criteria:
* Age less than 21 years at the time of enrollment
* Participants enrolled in a ChiLDReN based prospective observational cohort study (PROBE, BASIC, or LOGIC)
* Willingness and ability to participate in the study for up to 24 months
* One of the following three diagnoses
* Biliary atresia per ChiLDReN criteria or,
* Alpha-1 antitrypsin deficiency (PiZZ or SZ) or,
* Alagille Syndrome per ChiLDReN criteria
Exclusion Criteria:
* BA with known situs inversus or polysplenia/asplenia
* Presence of clinically significant ascites detected on physical examination
* Open wound near expected FibroScan probe application site
* Use of implantable active medical device such as a pacemaker or defibrillator
* Known pregnancy
* Prior liver transplant
* Unable or unwilling to give informed consent or assent
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
21 Years
Study:
NCT02922751
Study Brief:
Protocol Section:
NCT02922751