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 @ 4:25 PM
Ignite Modification Date:
2025-12-24 @ 4:25 PM
NCT ID:
NCT04014166
Eligibility Criteria:
Inclusion Criteria:
* Aged 18 to 60 years old, male or female;
* Conform to the diagnostic criteria of immune Thrombocytopenia (ITP);
* Three months after splenectomy;
* The first-line treatment drugs such as human immunoglobulin, glucocorticoid, and the second-line treatment of thrombopoietin drugs and rituximab were invalid, or there was no response or recurrence after splenectomy;
* Diagnosis of ITP\>6 months；
* More than 3 months after rituximab treatment；
* Platelet counts \<30 ×10\^9/L, and bleeding tendency;
* People who are willing to sign the informed consent voluntarily and follow the research program.
* Subject is practicing an acceptable method of contraception. Women of childbearing potential must have a negative serum pregnancy test in the whole study;
Exclusion Criteria:
* ECOG score standard \>2；
* Secondary thrombocytopenic purpura;
* Patients with poor compliance;
* Positive serology for HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), and/or hepatitis D virus (HDV), Syphilis; Positive for Epstein-Barr Virus DNA, Cytomegalovirus DNA;
* Pregnancy or lactation period;
* History of thrombosis;
* The serum chemistry results exceed the upper laboratory normal range by more than 20%, such as ALT, AST, TBIL, BUN, Cre etc;
* Pre-existing cardiac disease, including congestive heart failure of New York Heart Association \[NYHA\] Grade III/IV, arrhythmia requiring treatment or myocardial infarction within the last 6 months. No arrhythmia known to increase the risk of thrombotic events (e.g. atrial fibrillation), or patients with a QT \>450msec or QTc \> 480 for patients with a Bundle Branch Block;
* History of solid organ or bone marrow transplant;
* Researchers believe that patients should not participate in the test of any other condition.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT04014166
Study Brief:
Protocol Section:
NCT04014166