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 @ 4:11 AM
Ignite Modification Date:
2025-12-25 @ 4:11 AM
NCT ID:
NCT03691220
Eligibility Criteria:
Inclusion Criteria:
* The patient is ≥ 12 and \< 20 years of age at enrollment.
* ≥2.5 years after last liver transplantation.
* Guardian's consent, adolescent assent at enrollment.
* The patient is prescribed tacrolimus.
* The patient's MLVI (SD of tacrolimus) was \> 2 when calculated by the site for a period of 2 years prior to the review date
Exclusion Criteria:
* The patient has had transplant of an organ other than liver.
* The patient is currently listed for any organ transplantation.
* The patient is expected to transition to another service (e.g., adult clinic, another
* hospital) during the two years of the study.
* Pregnant patients.
* A temporary exclusion: the patient is not medically stable or was hospitalized for \>48 consecutive hours in the past three months.
* Site PI, study PI, or Medical Monitor determines that the patient should not be a candidate for the intervention due to factors that are not covered in the above criteria.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
19 Years
Study:
NCT03691220
Study Brief:
Protocol Section:
NCT03691220