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 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT04420494
Eligibility Criteria:
Inclusion Criteria:
* Age 18-80 years (adults, elderly), gender is not limited;
* The diagnosis is definitely immune cytopenia (IRC), including autoimmune hemolytic anemia (AIHA, Hgb \<100g / L, acquired pure red aplastic anemia (PRCA, Hgb \<100g / L, EVANS syndrome ES, Hgb \<100g / L and / or platelet count \<30 × 109 / L, or cytopenia secondary to immune diseases (same treatment as before, or neutrophils \<0.5 × 109 / L), at least after hormones If the treatment is not effective (PR has not been achieved after 4 weeks of hormone therapy) or cyclosporine 3-5mg / kg / d has not reached PR for half a year.
* Those without abnormal cardiac function, abnormal liver function (total bilirubin 1.5 × ULN, ALT, AST≤3.0 × ULN), and abnormal renal function (serum creatinine≤1.0 × ULN) ④ ECOG score 0, 1 or 2; ⑤ Except autoimmunity There is no other secondary disease other than the disease; ⑥ Clearly understand the content of the trial, voluntarily participate in and complete this trial, and voluntarily sign an informed consent.
Exclusion Criteria:
* Age \<18 years old or\> 80 years old;
* Patients with tumors (except carcinoma in situ); ③ Uncontrollable systemic infections or other serious diseases; ④ Women who are pregnant or lactating; ⑤ Patients with mental illness and potential impact Those with severe mental and mental illness who signed the informed consent form and followed up with the medical consultation;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04420494
Study Brief:
Protocol Section:
NCT04420494