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 @ 3:54 PM
Ignite Modification Date:
2025-12-24 @ 3:54 PM
NCT ID:
NCT01719692
Eligibility Criteria:
Inclusion Criteria:
* Age 18-60 years old;
* Diagnosis of primary immune thrombocytopenia according to the guidelines of American Society of Hematology for at least 3 months before inclusion;
* Platelet count \<30×109/L (measured at least twice during the screening, with at least a 1-week interval);
* Failed or dependent on or relapsed after previous treatment with glucocorticoid;
* If on glucocorticoid maintenance therapy, dose ≤0.5 mg/kg prednisone or equivalent and stabilised for at least 4 weeks;
* Drugs such as azathioprine, danazol, cyclosporine A, tacrolimus, and sirolimus stopped for at least 4 weeks;
* Splenectomy more than 6 months previously;
* Previous rescue therapy of ITP (including methylprednisolone, platelet transfusion and IVIG) completed at least 2 weeks before the first administration;
* Liver and kidney function (including alanine aminotransferase, aspartate aminotransferase, total bilirubin, serum creatine, urea nitrogen, etc.) less than 1.5 times the upper limit of normal value;
* Eastern Cooperative Oncology Group performance status ≤2;
* Cardiac function classification (New York Heart Association) ≤2;
* Understand the research procedure and voluntarily sign a written informed consent form.
Exclusion Criteria:
* Patients with secondary thrombocytopenia (including myelodysplastic syndrome, aplastic anemia, common variant immunodeficiency disease, hereditary thrombocytopenia, drug-induced thrombocytopenia, pseudothrombocytopenia, connective tissue disease secondary thrombocytopenia, thrombocytopenia after liver disease, etc.);
* Previous treatment of RTX or allergic to RTX;
* Uncontrollable primary diseases of important organs (including malignant tumor, liver failure, heart failure, kidney failure and other diseases);
* HIV-positive status;
* Active infection including hepatitis B (HBV), hepatitis C (HCV) and other viral antigens or DNA, RNA positive; cytomegalovirus, Epstein-Barr virus, syphilis chronic or active infection. If HBV core antibodies are positive, HBV-DNA testing is required.
* Extensive and severe bleeding, such as hemoptysis, upper gastrointestinal hemorrhage, intracranial hemorrhage, etc.
* Heart disease or arrhythmia need treatment, or poorly controlled hypertension;
* Thrombotic diseases including pulmonary embolism, thrombosis, atherosclerosis, etc.;
* Previously allogeneic stem cell transplantation or organ transplantation;
* Mental disorders who are unable to obtain informed consent normally and participate in trials and follow-up;
* Symptoms of toxicity from pre-trial treatment have not resolved;
* Other severe conditions that may limit participation in the trial (e.g., diabetes; severe cardiac insufficiency; myocardial infarction or unstable arrhythmia or unstable angina within the last 6 months; gastric ulcer; active autoimmune diseases, etc.);
* Sepsis or other irregular bleeding;
* Taking antiplatelet drugs;
* pregnancy, suspected pregnancy (urine human chorionic gonadotropin positive during screening) or lactation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01719692
Study Brief:
Protocol Section:
NCT01719692