Immune thrombocytopenia
Conditions
Interventions
Experimental group 1:Bids,po,50mg
Experimental group 2:Bids,po,75mg
Experimental group:Bids,po,100mg
Sponsors
Henan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Participants must meet all of the following criteria in order to be selected: 1) Age range of 18-80 years old (including threshold), gender not limited; 2) Disease diagnosis criteria: The 2020 Chinese guidelines for the diagnosis and treatment of adult primary immune thrombocytopenia, which meets the diagnosis of persistent (duration: 3-12 months) or chronic (duration:>=12 months) ITP, and the average platelet count before the first administration is less than 30 × 10 ^ 9/L (at least 1 day interval between them), and both platelet counts are less than or equal to 35 × 10 ^ 9/L; 3) Patients who have previously received at least one first-line treatment for ITP (corticosteroids and/or intravenous immunoglobulin) but have failed (poor efficacy, inability to maintain efficacy, or recurrence) or developed glucocorticoid intolerance. (Poor efficacy refers to platelet count80g/L can be included in the group), white blood cell count>=2.5 × 10 ^ 9/L, and neutrophil count>=1.5 × 10 ^ 9/L within the first week of randomization; Serum creatinine<=1.5 x upper limit value (ULN); AST and ALT<=2.5 × ULN; Total bilirubin (TBIL) and direct bilirubin (DBIL)<=1.5 × ULN; PT and APTT<1.5 × ULN, INR<1.5 (unless there is evidence to suggest no association with coagulation or bleeding disorders); 7) Understand the experimental procedures and methods, voluntarily participate in this trial, comply with relevant research procedures such as treatment, examination, follow-up, precautions, lifestyle, etc., and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1) Patients with severe ITP at the time of screening were judged not suitable for participation in this study (such as life-threatening thrombocytopenia, major bleeding events, or symptoms or signs indicating the presence of major bleeding events, etc.); 2) Bleeding symptoms requiring interventional treatment (such as minimally invasive interventional hemostasis assisted by imaging equipment and hematoma discharge treatment) occurred within 4 weeks before screening; 3) Intracranial hemorrhage occurred within 6 months before screening; 4) In addition to ITP, other diseases or medical history leading to coagulation disorders and high risk of bleeding, such as diffuse intravascular coagulation, decompensated cirrhosis, esophageal and gastric varices, etc.; 5) Combined with a variety of secondary thrombocytopenia diseases or medical history, such as myelofibrosis, myelodysplastic syndrome, aplastic anemia, lymphoproliferative diseases, antiphospholipid syndrome, thrombocytopenia purpura, Fanconi syndrome, von Willebrand disease, immune diseases such as systemic lupus erythematosus, drug-induced thrombocytopenia, etc.; 6) An active infection requiring hospitalization for antimicrobial therapy occurred 4 weeks prior to screening; 7) Heart disease, including New York Heart Association (NHYA) Class III/IV congestive heart failure, arrhythmias requiring medication or myocardial infarction, or arrhythmias known to increase the risk of thrombotic events (such as atrial fibrillation), within the 3 months prior to screening; 8) History of arterial or venous thromboembolism (such as stroke, transient ischemic attack, deep vein thrombosis, or pulmonary embolism) within 6 months prior to randomization; 9) There was HIV infection during the screening period; If HBSAG is positive, HBV-DNA testing is required. If HBV DNA is >=1000 copies /ml, it should be excluded. If HCV antibody is positive, HCV-RNA should be performed. If HCV-RNA is >=1000 copies /ml, it should be excluded. 10) Tuberculosis subjects with positive screening tests at the time of screening (such as positive screening test results, but combined with chest CT results, the investigator determines that the positive results are not clinically significant, can be enrolled), or active, or potential, or have not completed appropriate standard treatment for tuberculosis; 11) Previous history of malignant tumors (except for patients with fully treated cervical carcinoma in situ, breast ductal carcinoma in situ after radical surgery, and local prostate cancer); 12) Subjects with known immunodeficiency diseases or first-degree relatives with hereditary immunodeficiency; 13) Patients who underwent major surgical procedures within 4 weeks prior to screening or who are expected to require major surgical treatment during the study period; 14) Previous BTK inhibitor treatment (such as ibrutinib, etc.); 15) Received vincristine, all-trans retinoic acid, and decitabine within 30 days before randomization; 16) Received blood transfusion therapy (including platelet transfusion), ITP adjuvant drug therapy such as Likejun tablet, Chinese patent medicine, etc., within 1 week before randomization; 17) Received ITP emergency treatment within 2 weeks before randomization, such as: methylprednisolone and other glucocorticoids, gamma globulin, TPO preparations (except long-acting preparations); 18) Received rituximab or other anti-CD20 drugs, cyclophosphamide, and phenylbutyrate in the 6 months before randomization;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects with platelet counts =50×10^9/L (at least 2 consecutive tests and at least 7 days apart) during treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinically significant persistent platelet response at week 24, defined as the proportion of subjects with a platelet count =50×10^9/L in at least four of the last six visits during the 24 week period without remedial treatment;Proportion of subjects with platelet count =30×10^9/L and =50×10^9/L at weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24 after treatment;Proportion of subjects with at least one platelet count =30×10^9/L, =50×10^9/L;The time required from the start of the study until the first platelet count =30×10^9/L, =50×10^9/L;;The subject's platelet count lasted =30×10^9/L, the longest duration =50×10^9/L;Proportion of participants in the study who received remedial treatment;Occurrence of adverse events; | — |
Countries
China
Contacts
Public ContactHu Zhou
Henan Cancer Hospital
Outcome results
None listed