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 @ 5:54 PM
Ignite Modification Date:
2025-12-24 @ 5:54 PM
NCT ID:
NCT05281068
Eligibility Criteria:
Inclusion Criteria:
* Primary immune thrombocytopenia (ITP) confirmed by excluding other supervened causes of thrombocytopenia;
* Platelet count of less than 30×109/L at enrollment;
* Patients who did not achieve a sustained response to treatment with full-dose corticosteroids for a minimum duration of 4 weeks or who relapsed during steroid-tapering or after its discontinuation;
* 18 years older;
Exclusion Criteria:
* Secondary immune thrombocytopenia (e.g., patients with HIV, HCV, Helicobacter pylori infection or patients with systemic lupus erythematosus)
* Congestive heart failure
* Severe arrhythmia
* Nursing or pregnant women
* Aspartate aminotransferase and alanine transaminase levels ≥ 3× the upper limit of the normal threshold criteria
* Creatinine or serum bilirubin levels each 1•5 times or more than the normal range
* Active or previous malignancy
* Unable to do blood routine test for the sake of time, distance, economic issues or other reasons.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05281068
Study Brief:
Protocol Section:
NCT05281068