Primary Immune Thrombocytopenia
Conditions
Interventions
Therapy Group:Otuzumab (1000mg each time, once every two weeks, a total of 2 times, intravenous drip)
Sponsors
The Second Affiliated Hospital of Kunming Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Age 18-70 years old, male or female (2) ITP patients with ineffective or hormone-dependent first-line hormone therapy; (3) Platelet count =30×109/L or platelet count <50×109/L with bleeding symptoms; (4) Those who can understand the procedures and methods of this study, voluntarily sign the informed consent form, and strictly abide by the clinical trial protocol; (5) Subjects agree to take effective contraceptive measures during the trial and within 12 months after the last dose.
Exclusion criteria
Exclusion criteria: 1) HCV antibody, HBs antigen, HBc antibody, HIV antibody positive; 2) Secondary thrombocytopenia 3) Received live vaccine within 4 weeks before screening; 4) Active tuberculosis and other uncontrolled active infections; 5) Decreased renal function, serum creatinine > 1.5 times the upper limit of normal; 6) Abnormal liver function, AST or ALT > 2.5 times the upper limit of normal; 7) Angina pectoris, heart failure, myocardial infarction, severe arrhythmia, etc. or related medical history; 8) Suffering from cancer or a history of cancer; 9) A history of serious mental illness; 10) Received any monoclonal antibody treatment within the past 4 months (except for ineffective rituximab treatment); 11) Received any research drug or participated in other clinical research within 6 months before admission; 12) Pregnant and lactating women; 13) Other researchers think that it is not suitable to participate in the research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| PR,CR;safety;quality of life;Adverse reactions;Recurrence rate; | — |
Countries
China
Contacts
Public ContactZePing Zhou
The Second Affiliated Hospital of Kunming Medical University
Outcome results
None listed