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 @ 4:01 PM
Ignite Modification Date:
2025-12-24 @ 4:01 PM
NCT ID:
NCT02892266
Eligibility Criteria:
Inclusion Criteria:
The patient:
* and/or their parent(s)/guardian must be able to understand and provide informed consent in English or Spanish;
* is prescribed tacrolimus (either brand or generic formulation); and
* has been seen in the enrolling center's clinic at least twice in the last two years.
Exclusion Criteria:
The patient:
* received a transplant less than 18 months prior to enrollment;
* has had more than one transplant (including marrow replacement);
* or their parent(s)/guardian is actively psychotic or severely disoriented due to any cause, including hepatic encephalopathy (temporary exclusion);
* or their parent(s)/guardian has been diagnosed with severe intellectual disability as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5);
* is not medically stable or is hospitalized;
* is currently enrolled in a study that aims to improve adherence to medical recommendations;
* is receiving cognitive behavioral therapy for confirmed or suspected diagnosis of Post-Traumatic Stress Disorder (PTSD) at enrollment;
* is receiving psychotropic medications for a confirmed or suspected diagnosis of PTSD.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
17 Years
Study:
NCT02892266
Study Brief:
Protocol Section:
NCT02892266