Primary immune thrombocytopenia
Conditions
Interventions
Group 1:belimumab and cyclosporine
Sponsors
The Second Affiliated Hospital of Kunming Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age >=18, male or female. 2. Platelet count <=30*10^9/L or platelet count <50*10^9/L accompanied with bleeding symptoms; 3. Corticosteroid-refractory(corticosteroid-ineffective/corticosteroid-dependent/relapse) ITP, the course of the disease is more than 3 months; 4. Splenectomy was not performed; 5. Patients receiving other maintenance regimens (including but not limited to: corticosteroids, azathioprines, danazoles, or mycophenolate mofetil) were also eligible if the treatment dose remained stable within the past month and the dose was expected to be stable after enrollment, at least for the first 2 weeks of the study until the initial response was assessed; 6. Fully understand and comply with the requirements of the research protocol.
Exclusion criteria
Exclusion criteria: 1) Have a history of severe allergic illness or allergies to study medications. 2) Women who are pregnant or breast-feeding, or who plan to become pregnant during the study. 3) There are angina pectoris, myocardial infarction, heart failure, serious arrhythmia or other related history. 4) Combined use of anticoagulants or antiplatelet drugs. 5) Abnormal liver and kidney function: · Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 3 times the upper limit of normal. · Total bilirubin > 1.5 times the upper limit of normal. · Creatinine exceeds the upper limit of normal by 1.5 times. 6) Received gamma globulin therapy within 2 weeks prior to the initial study. 7) Received rituximab treatment within 24 weeks prior to the initial study. 8) Participated in clinical trials of other drugs 1 month prior to the initial study medication or within 5 drug half-life periods (whichever is longer). 9) Uncontrolled hypertension (blood pressure still greater than 160/100mmHg after treatment). 10) A history of malignant tumor. 11) Positive for HBV surface antigen, HCV antibody, HIV antibody (? + ?) and syphilis antibody. 12) Active tuberculosis infection or infection with other pathogens. 13) Receive live attenuated vaccine within 1 month before the initial study medication, or plan to receive live attenuated vaccine during the study period. 14) hypogammaglobulinemia (IgG<400mg/dl) or IgA deficiency (IgA<10mg/dl). 15) History of vital organ transplantation. 16) Depression or suicidal thoughts. 17) Other conditions in which the investigator considered that the patient should not participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Initial response rate;Time to effect;Reaction duration;Bleeding events; | — |
Countries
China
Contacts
Public ContactBi Hui
The Second Affiliated Hospital of Kunming Medical University
Outcome results
None listed