primary immune thrombocytopenia
Conditions
Interventions
experimental group:hetrombopag plus high-dose dexamethasone
Sponsors
The First Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age =18 years, gender not limited; 2.Clinically diagnosed with primary immune thrombocytopenia before enrollment, with a platelet count less than 30×10^9/L within 48 hours before the first intake of the study drug; 3.Patients who have not received a treatment regimen for ITP; 4.Prothrombin time not exceeding the normal range by ±3 seconds, activated partial thromboplastin time not exceeding the normal range by ±10 seconds; no history of coagulation disorders other than ITP; 5.Voluntarily signing an informed consent form;
Exclusion criteria
Exclusion criteria: 1.Bone marrow dysplasia syndrome, immune diseases such as systemic lupus erythematosus, early aplastic anemia, atypical aplastic anemia, antiphospholipid syndrome, thrombotic thrombocytopenic purpura, and other secondary thrombocytopenia caused by various reasons; 2.Patients with any arterial or venous thrombosis (stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis, or pulmonary embolism), or clinical symptoms and history suggesting a predisposition to thrombosis; 3.Within 3 months prior to screening, patients with cardiac diseases, including New York Heart Association (NYHA) class III/IV congestive heart failure, arrhythmias requiring medication, myocardial infarction, or known arrhythmias that increase the risk of thrombotic events (such as atrial fibrillation), or subjects with prolonged corrected QT interval (QTc > 450 milliseconds, or subjects with bundle branch block with QTc > 480 milliseconds); 4.Participation in other clinical trials within 3 months prior to screening; 5.Within 2 weeks prior to screening, subjects who have continuously used medications affecting platelet function (including but not limited to aspirin, aspirin-containing compounds, clopidogrel, salicylates, and/or non-steroidal anti-inflammatory drugs NSAIDs) or anticoagulant therapy for more than 3 days; 6.Bone marrow biopsy results during the screening period indicating bone marrow fibrosis MF=2 (European expert consensus bone marrow fibrosis scoring standard Thieleja 2005), or bone marrow biopsy suggesting the presence of other primary diseases that can cause thrombocytopenia besides ITP; 7.HIV infection or positive hepatitis C antibodies during the screening period (if hepatitis B surface antigen is positive, or hepatitis B surface antigen is negative but hepatitis B core antibody is positive, HBV-DNA test is required, and subjects with viral replication should be excluded); 8.Alanine aminotransferase (ALT), aspartate aminotransferase (AST) greater than 1.5 times the upper limit of the normal range, total bilirubin, and creatinine greater than 1.2 times the upper limit of the normal range during the screening period; 9.History of liver cirrhosis or portal hypertension; 10.History of malignant tumors or associated with malignant tumors; 11.Pregnant or lactating women; 12.Patients with potential fertility who are unwilling to use effective contraceptive measures throughout the trial period and 14 days after the end of the trial (or early termination of the trial); 13.Investigators believe that there are any other conditions that may prevent the subject from completing this study or bring significant risks to the subject;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients who achieved platelet response (post-treatment platelet count =30×109/L, at least 2 times higher than baseline platelet count, and no bleeding manifestations) at 8 weeks; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence and severity of bleeding symptoms according to the WHO bleeding score;Proportion of patients who achieved platelet response (platelet count =30×109/L after treatment, at least 2 times higher than baseline platelet count, and no bleeding manifestations) at 2, 4, 12, and 16 weeks;The number of platelet transfusions, the total amount of dexamethasone used, and the incidence of glucocorticoid side reactions;HRQoL situation; | — |
Countries
China
Contacts
Public ContactZhu Huachao
The First Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed