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 @ 2:49 PM
Ignite Modification Date:
2025-12-24 @ 2:49 PM
NCT ID:
NCT03318159
Eligibility Criteria:
Inclusion Criteria:
1. willing and able to provide written informed consent for voluntary participation in the trial
2. adult patients (≥18 years, \<75 years old)
3. no QTc prolongation on initial ECG
4. Adequate organ function for treatment as follows:
A. Absolute neutrophil count \> 1.5 x 109/L B. Platelets \>100 x 109/L C. Serum creatinine ≤ 2.0 x ULN (upper limit of normal) D. Serum bilirubin ≤ 1.5 x ULN E. AST and ALT ≤ 2.0 x ULN
Exclusion Criteria:
1. those suspected of fungal infection within 30 days of ATG treatment
2. those allergic to -triazoles
3. those with history of malignancies within 5 years and/or concomitant malignancy other than AA/hMDS
4. those with history of chemotherapy, radiotherapy and/or other immunosuppressants
5. female patients who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control
6. active HBV, HCV patients
7. HIV positive patients
8. those with history of receiving organ transplantation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03318159
Study Brief:
Protocol Section:
NCT03318159