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 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 1:14 AM
NCT ID:
NCT02833493
Eligibility Criteria:
Inclusion Criteria:
1. Male or female of 18-80 year old.
2. With blood transfusion history or RBC-transfusion-dependence.
3. BM smear and biopsy plus chromosome analysis within 3 months before signing ICF, otherwise done during screening.
4. Excluding other diseases which might cause hematological abnormalities.
5. Serum ferritin level≥500ng/ml with no sign of active infection or malignant disease.
6. Treatment with underlying disease is permitted for non-hematological and hematological conditions.
7. Previous iron chelation therapy like deferasirox or deferoxamine is permitted.
8. ECOG performance score ≤2
9. All subjects must: agree not to donate blood or be counseled about pregnancy precautions and risks of fetal exposure.
10. Written informed consent.
Exclusion Criteria:
1. Patients who are under 18-year-old or over 80-year-old.
2. Prior history of other cancer unless cancer-free for ≥5 years.
Subjects with the following history/concurrent conditions may enroll at any time:
Basal cell carcinoma of the skin Squamous cell carcinoma of the skin Prostate cancer stage-1
3. Proved HIV-1 infection
4. Active HBV or active HCV infection.
5. Pregnant or lactating
6. Patients unwilling to or unable to comply with the protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02833493
Study Brief:
Protocol Section:
NCT02833493