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 @ 5:04 AM
Ignite Modification Date:
2025-12-25 @ 5:04 AM
NCT ID:
NCT01409018
Eligibility Criteria:
Inclusion Criteria:
* Pediatric patients who are under chemotherapy, and receive itraconazole.
Exclusion Criteria:
1. Patients with significant functional deficits in major organs, but the following eligibility criteria may be modified in individual cases.
* Heart : fractional shortening \< 30%, ejection fraction \< 45%
* Liver : total bilirubin ≥ 2 x upper limit of normal (ULN) ; aminotransferase ≥ 3 x ULN
* Kidney : creatinine ≥ 2 x normal or GFR ≤ 60㎖/min/1.73㎡
2. Patients with hypersensitivity to azoles.
3. Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
4. Pregnant or nursing women.
5. Psychiatric disorder that would preclude compliance.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT01409018
Study Brief:
Protocol Section:
NCT01409018