Primary Immune Thrombocytopenia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18-65 years old, male or female; 2. ITP patients with ineffective first-line hormone treatment or hormone dependence; 3. Platelet count <= 30 x 10^9/L or platelet count < 50 x 10^9/L with bleeding symptoms; 4. Patients who can understand the procedures and methods of this study, and are willing to sign informed consent and strictly abide by the clinical trial protocol; 5. Patients who agree to use effective contraception during the study period and within 12 months after the end of the last dose.
Exclusion criteria
Exclusion criteria: 1. Positive for HCV antibody, HBs antigen, HBc antibody and HIV antibody; 2. Secondary thrombocytopenia 3. Live vaccine was inoculated within 4 weeks before screening; 4. Active pulmonary tuberculosis; 5. Decreased renal function, serum creatinine >1.5 times normal upper limitation; 6. Abnormal liver function, upper limit of AST or ALT>2.5 times normal value; 7. Angina pectoris, heart failure, myocardial infarction, severe arrhythmia or related medical history; 8. Having or having a history of cancer; 9. A history of severe mental illness; 10. Received any monoclonal antibody therapy within the last 4 months; 11. Received any research drugs or participated in other clinical studies within 6 months before enrollment; 12. Pregnant or lactating women; 13. Other conditions deemed inappropriate by the researcher to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Platelets counts; | — |
Countries
China
Contacts
Department of Hematology, the Second Affiliated Hospital of Kunming Medical University