immune thrombocytopenia
Conditions
Interventions
Administer fostamatinib for 24 weeks. The initial dose of the fostamatinib is 100 mg orally twice daily. If the target platelet count does not increase after 4 or more weeks administration, and there
C523665
Sponsors
Miyakawa Yoshitaka
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria can be enrolled in this study; 1) Patients aged 18 years or older at consenting 2) Patients diagnosed with ITP at least 6 months prior to the consenting according to the ITP Diagnostic Criteria (revised in 1990) by the Idiopathic Hematopoietic Disorders Study Group of the Ministry of Health and Welfare 3) Patients with a latest platelet count of less than 30,000/microL (within 2 months prior to the consenting) 4) Patients who are using or have previously used one or more of the following ITP medications at consenting - Corticosteroids (prednisolone 10 mg/day or less, or corticosteroids of the same potency) - Thrombopoietin receptor agonists (eltrombopag Olamine or Romiplostim etc.) Azathioprine, cyclosporine, mycophenolate mofetil, danazol 5) Patients meeting any of the followings; - Positive aPL (anti-cardiolipin antibody, lupus anticoagulant, or anti-beta2GPI antibody) within 12 months prior to the consenting - History of thrombosis before the consenting 6) Patients who give their written consent to participate in this study
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from the study; 1) Patients with thrombocytopenia or induced or alloimmune thrombocytopenia associated with other diseases (e.g., malignant lymphoma, chronic lymphocytic leukemia, viral infection, autoimmune disease, thyroid disease, human immunodeficiency virus, hepatitis or myelodysplastic syndrome) 2) Patients with hepatic cirrhosis 3) Patients with concomitant malignancy 4) Patients diagnosed with secondary ITP 5) Patients with suspected cyclic thrombocytopenia 6) Patients who have had a cardiovascular event such as myocardial infarction, unstable angina, stroke, pulmonary embolism, NYHA class III or IV heart failure, or other arterial or venous thrombosis within 2 months prior to the consenting 7) Patients with hypertension that is difficult to control with antihypertensive drugs 8) Patients with a neutrophil count of less than 1,000/microL at the consenting 9) Patients with any of the following laboratory abnormalities at consenting - ALT or AST >=120 U/L - Total bilirubin >=3 mg/dL 10) Patients who have received at least one of the following treatments within 2 months prior to the consenting - Blood transfusion including blood products for transfusion - Intravenous immunoglobulin products Injection methylprednisolone - Oral/intravenous dexamethasone (except at the same or lower titer as prednisolone at 10 mg/day) - Oral prednisolone (except at 10 mg/day or lower) 11) Patients treated with the following ITP medications within 2 months prior to the date of consent - Alkylating agents - Efgartigimod 12) Patients who used rituximab or other anti-CD20 monoclonal antibody within 6 months prior to the consenting 13) Patients who have taken fostamatinib in the past 14) Patients who have undergone splenectomy within 3 months prior to the consenting 15) Patients who have undergone major surgery within 1 month prior to the consenting or whose surgical wounds have not completely healed at consenting 16) Pregnant women or women who may be pregnant or nursing mothers 17) Patients with other contidions that the principal investigator or subinvestigator determines to be inappropriate as research subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients who achieved the platelet count of 50,000 microL or higher at least once between week 16-24 of the fostamatinib administration | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Proportion of patients who achieved the platelet count of 50,000 microL or higher at week 24 of the fostamatinib administration 2) Proportion of patients who achieved the platelet count of 10,000 microL or higher at week 24 of the fostamatinib administration 3) Proportion of patients who achieved the platelet count of 30,000 microL or higher, and twice from baseline at week 24 of the fostamatinib administration 4) Proportion of patients who achieved the platelet count of 50,000 microL or higher at least once from baseline to week 12 of the fostamatinib administration 5) Number of observation points at when each patient achieved the platelet count of 50,000 microL or higher among week 2-24 (7 observation points) 6) Change in the platelet count from baseline to each observation point (the platelet count at baseline is determined as the mean of it at week 0 and the latest one before week 0) | — |
Contacts
Public ContactYoshitaka Miyakawa
Saitama Medical University Hospital
Outcome results
None listed