hemophilia
Conditions
Interventions
experimental group:Zanubrutinib 160mg orally twice daily
Sponsors
He'nan Cancer Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Men or women aged >= 18 and = 12 months) ITP. 3.Subjects must have responded to a previous ITP treatment within 3 years (platelet count > 50 x 10^9 / L) or bone marrow examination consistent with ITP to exclude other causes of myelodysplastic syndrome (MDS) or thrombocytopenia. 4.The results of peripheral blood smear should support the diagnosis of ITP, and there is no evidence of other causes of thrombocytopenia (such as pseudothrombocytopenia and bone marrow fibrosis). The physical examination results shall not show any disease that may cause thrombocytopenia except ITP. 5.Subjects who have previously received one or more ITP treatments (including but not limited to glucocorticoids, immunoglobulins, azathioprine, danazol, cyclophosphamide and / or rituximab) and have no other treatment options. 6.The laboratory test meets the following conditions (no treatment for abnormal indicators within 1 week before blood collection): (1) During the screening visit and / or before the administration of the first study drug, the average value of two platelet counts (the interval between two tests is more than 24 hours at least) is 35 x 10^9/L; (2) Hemoglobin >= 90g / L (if it is determined as iron deficiency anemia, hemoglobin > 80g / l can be included in the group), leukocyte > 2.5 x 10^9 / L, neutrophils > 1.5 x 10^9/L (3) Serum creatinine concentration = 50ml / min; (4) Total bilirubin (TBIL), ALT and AST <= 2 x ULN (5) Serum amylase or lipase did not exceed the upper limit of the normal range; (6) The international normalized ratio (INR) and activated partial thromboplastin time (APTT) values did not exceed 20% of the normal range. 7.In this study, the subjects were allowed to receive a stabilizer amount of anti ITP drugs combined with treatment. The detailed requirements are as follows: (1) Glucocorticoid: stable dose (equivalent to prednisone <= 20 mg / day) has been maintained at least 2 weeks before the first study medication, or the medication has been stopped 2 weeks before the first study medication; (2) Thrombopoietin receptor agonists (TPO RAS): the dose remained unchanged for 4 weeks before the first study medication, or TPO Ras was discontinued for at least 2 weeks before the first study medication. (3) Danazol: the dose remained unchanged for 3 months before the first study; Or danazol has been discontinued for at least 2 weeks before the first study medication; (4) Immunosuppressants (azathioprine, cyclosporine A and mycophenolate mofetil only): the dose remained unchanged within 3 months before the first study; Or the immunosuppressant has been stopped for at least 2 weeks before the first study medication; 8. Fertile male or female subjects must agree to use effective contraceptive methods, such as double barrier contraceptives, condoms, oral or injectable contraceptives, intrauterine devices, etc., during the study period and
Exclusion criteria
Exclusion criteria: 1.Suffering from other secondary thrombocytopenia: such as secondary thrombocytopenia caused by autoimmune diseases, thyroid diseases, lymphoproliferative diseases, myelodysplastic syndrome, malignant hematological diseases, chronic liver diseases, hypersplenism, common variant immunodeficiency diseases and infection; 2.The subjects had multilineage immune hemopenia, such as Evans syndrome and autoimmune pancytopenia; 3.Subjects with malignant tumor diseases (except clinically cured cervical carcinoma in situ, squamous cell carcinoma or skin basal cell carcinoma); 4.The subjects had a history of coagulation disorders other than ITP, such as disseminated intravascular coagulation, hemolytic uremic syndrome, thrombotic thrombocytopenic purpura, etc; 5.History of important organ transplantation or hematopoietic stem cell / bone marrow transplantation; 6.Before screening, there were any history of arterial or venous thrombosis in the June (stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis or pulmonary embolism), and there were 2 risk factors: estrogen replacement therapy or contraception therapy, smoking, diabetes, hypercholesterolemia, hypertension drugs, tumor, etc. Hereditary thrombotic diseases (such as factor V Leiden, antithrombin III deficiency, etc.), any other family history of arterial or venous thrombosis, or patients who were using anticoagulants or antiplatelet drugs at the beginning of screening; 7.Subjects with a history of severe cardiovascular disease within the first 6 months of screening (such as nyhaiii / IV congestive heart failure, arrhythmia [such as atrial fibrillation] and angina pectoris that increase the risk of thromboembolic events, and subjects who have undergone coronary stent replacement, angioplasty and coronary artery bypass grafting); 8.Subjects with hepatitis B virus surface antigen positive, hepatitis B virus DNA copy number exceeding 1000IU / ml, hepatitis C virus antibody positive, and history of acute hepatitis, liver cirrhosis, portal hypertension or chronic active hepatitis; 9.HIV antibody positive; 10.Subjects known to be allergic to zebutinib or any of its excipients. 11.medication history and operation history: (1) Splenectomy or rituximab within 12 weeks before the first study drug; (2) Immunoglobulin (IVIG) was used within 1 week before the first study medication; (3) Platelet transfusion was received within 1 week before the first study medication; (4) Cyclophosphamide or vinblastine administration regimen was used within 4 weeks before the first study; (5) Subjects currently receiving glucocorticoid treatment who failed to maintain a stable dose within 2 weeks before the first study medication or did not complete these treatments before 2 weeks before the first study medication; (6) Subjects currently receiving immunosuppressants (azathioprine, cyclosporine A, mycophenolate mofetil only) or danazol, who did not maintain a stable dose within 12 weeks before the first study or did not complete these treatments more than 2 weeks before the first study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| platelet count; | — |
Secondary
| Measure | Time frame |
|---|---|
| physical examination;Vital signs; | — |
Countries
China
Contacts
Public ContactHu Zhou
He'nan Cancer Hospital
Outcome results
None listed