Idiopathic Thrombocytopenic Purpura
Conditions
Sponsors
Keio University School of Medicine ,
Yoshitaka miyakawa
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Diagnosis of ITP according to guidelines (The Study Group for Intractable Hematopoietic Diseases supported by the Ministry of Health and Welfare, Japan. 1991) at least 12 months before entry 2)A platelet count =20 years old 5)Patient who was ineffective or intolerable for steroid 6)Patient who was ineffective or judged as being inappropriate for splenectomy by investigators 7)Patient who was ineffective or intolerable or judged as being inappropriate by investigators for thrombopoietin-receptor 8)Hemoglobin>=10g/dL 9)Creatinine<=2mg/dL 10)Total bilirubin smaller than 1.5 X upper limit of normal,ALT and AST smaller than 3 X upper limit of normal 11)Written informed consent
Exclusion criteria
Exclusion criteria: 1)Patients with past medical history of allergy to Rituximab 2)Patients with serious somatic symptom(excluding ITP) 3)Patients with alcoholism within 1 years 4)Patients with suspected blood disorder (excluding ITP) 5)Patients with suspected cyclic thrombocytopenia 6)HIV, HCV,HBc antibody or HBs antigen positivity 7)Patients with no active malignancy or history 8)Patients being treated for TIP at study entry(excluding Patients who have taken steroid,azathioprine,danazol,cyclosporin or mycophenolate mofetil during a certain period of time prior to the study entry.) 9)Patients who have taken platelet transfusion,immunoglobulin therapy ,splenectomy, steroid,and so on drugs within a certain period of time prior to the study entry. 10)Patients who have taken antineoplastic within 8 weeks prior to study entry 11)Patients who have taken antibody drugs 12)Females who are pregnant or desire childbearing. 13)Patients judged as being inappropriate for this study by investigators 14)Patients under other clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate:platelet count 50,000/micro L at 24 weeks after therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Change in platelet count 2)Proportion of patients with a reduction in concomitant ITP medication 3)Improvement rate of bleeding symptoms(WHO bleeding Scale) 4)Safety parameters(adverse event reporting and clinical laboratory tests) 5)Change in blood Bcell(CD19,CD20), Tcell(CD3) 6)Change in serum IgG,IgM,IgA | — |
Countries
Japan
Contacts
Public ContactKayoko Kikuchi
Keio University School of Medicine
Outcome results
None listed