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 @ 6:35 PM
Ignite Modification Date:
2025-12-24 @ 6:35 PM
NCT ID:
NCT03218657
Eligibility Criteria:
Inclusion Criteria:
1. All the patients meet a NSAA diagnostic criteria, and agree the immunosuppressive therapy. Diagnoses reference to The diagnostic and therapeutic criteria for hematologic diseases（Zhang Zhinan 2007）, and The diagnosis and treatment of aplastic anemia（2016 UK guidelines）
2. 18-70years old, male or female
3. Liver and kidney function: the blood bilirubin is less than or equal to 2mg/dL (35 mol/L), AST/ALT in the upper limit of the normal value below 2 times, blood inosine is less than or equal to 177 umol/L.
4. Heart function is normal: EF\>50%.
5. No serious lung infection.
6. All cases had no history of cancer and chemotherapy history, immunology therapy. The control group without hematologic diseases, lupus or other immune disfunctions, allergic disease, Fanconi anemia.
7. Consent signed by patients or their families.
Exclusion Criteria:
1. Congenital hematopoietic failure, Fanconi anemia, or combined with bone marrow hyperplasia, leukemia, multiple myeloma, giant cell anemia, paroxysmal nocturnal hemoglobin or other blood diseases.
2. The HBV DNA copy number is greater than 1000/ml or the serum hepatitis B virus is not clear.
3. Serum bilirubin \> 2mg/dL (35 umol/L); ALT or AST \> 2 times the normal value of the upper limit; alkaline phosphatase \> 3 times the upper limit of the normal value; serum creatinine \> 177 mol/L.
4. HIV positive.
5. Other serious diseases that may limit the patient to participate in the study (e.g., the progressive infection, incontrollable diabetes, severe cardiac insufficiency or angina pectoris, etc.)
6. Conditions are not suitable for immunosuppressive therapy.
7. Pregnant or lactating women.
8. Can not understand or follow the research program.
9. Patients under 16 years of age.
10. Patients with a history of cancer, chemotherapy, or radiation therapy, immune system diseases or allergic diseases.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03218657
Study Brief:
Protocol Section:
NCT03218657