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 @ 1:16 AM
Ignite Modification Date:
2025-12-25 @ 1:16 AM
NCT ID:
NCT05996393
Eligibility Criteria:
Inclusion Criteria:
1. Patients with newly diagnosed severe aplastic anemia, aged greater than 60 years.
2. Patients met the diagnostic criteria of severe aplastic anemia (SAA).
3. Complete all screening assessments as outlined in the test protocol.
4. Without or with no more than 1 month treatment of ciclosporine, tacrolimus, glucocortocoid, or TPO-RAs.
5. Agree to sign the informed consent form.
Exclusion Criteria:
1. Known diagnosis of congenital hematopoietic failure disorders (e.g. Fanconi anemia) and other causes of cytopenia.
2. Patients with uncontrolled bleeding and/or infection despite standard treatment.
3. Patients with previous history of hematopoietic stem cell transplantation.
4. Patients with previous history of thrombosis in 1 year.
5. Patients with concurrent malignancy.
6. Those who are considered unsuitable for enrollment by the investigator.
7. Abnormal renal function: creatinine \> 1.2 normal upper limit, albumin \< 0.9 normal lower limit, or CLcr \< 30 ml/min.
8. Abnormal liver function: transaminase \> 2.5 normal upper limit, or tota bilirubin \> 2.5 normal upper limit.
9. Patients with severe heart, liver or renal disease.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT05996393
Study Brief:
Protocol Section:
NCT05996393