Primary immune thrombocytopenia
Conditions
Interventions
Intervention Group:Oral Hertrapolpa ethanolamine tablets
Sponsors
West China Hospital,Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Age>=18 years old, regardless of gender. 2)The clinical diagnosis of primary immune thrombocytopenia was less than 3 months before enrollment, and the platelet count within 48 hours before the first administration of the study drug was < 30*109/L. 3)Prednisone 1mg/kg/d (maximum dose 80mg/d) for 4~6 weeks was ineffective or two rounds of high-dose dexamethasone 40 mg/d * 4d pulses therapy were invalid; 4)No splenectomy and have not received any drug treatment for ITP other than glucocorticoid; 5)The prothrombin time was within +/-3s of the normal range, and the activated partial thromboplastin time was within +/-10s.And there is no history of other coagulation disorders except for ITP; 6)Understand the research procedure and sign the informed consent in writing voluntarily.
Exclusion criteria
Exclusion criteria: 1)Secondary thrombocytopenia caused by myelodysplastic syndrome, immune diseases such as systemic lupus erythematosus, early stage of aplastic anemia, atypical aplastic anemia, antiphospholipid syndrome, thrombotic thrombocytopenic purpura and other reasons; 2)The patient has had any arterial or venous thrombosis (stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis, or pulmonary embolism), or clinical symptoms and medical history suggest thrombophilia; 3)Heart diseases occurred within 3 months before the screening, including congestive heart failure of New York Heart Association (NHYA) class III/IV, arrhythmia or myocardial infarction requiring drug treatment, or arrhythmia known to increase the risk of thrombotic events (such as atrial fibrillation), or prolonged adjusted QT interval (QTc) of subjects (QTC > 450ms, or QTc>480 ms in subjects with bundle branch block.) 4)Participated in other clinical trials within 3 months prior to screening; 5)During the 2 weeks prior to screening, subjects had been treated continuously with medications (including but not limited to aspirin, aspirin-containing complexes, clopidogrel, salicylate, and/or non-steroidal anti-inflammatory drugs NSAIDs) or anticoagulants affecting platelet function for more than 3 days; 6)During the screening period, the results of bone marrow biopsy indicated myelofibrosis MF>=2 (European Consensus Score For Bone Marrow Fibrosis, Thieleja 2005), or the bone marrow biopsy indicated that the presence of other primary diseases besides ITP that could cause thrombocytopenia; 7)HIV infection or hepatitis C antibody positive 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 testing is required, and if virus replication is indicated, the subject should be excluded); 8)During the screening period, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were 1.5 times higher than the upper limit of normal values, and total bilirubin and serum creatinine were 1.2 times higher than the upper limit of normal values; 9)History of cirrhosis or portal hypertension; 10)History of malignant tumor or be accompanied by malignant tumor; 11)Pregnant or lactating women; 12)Patients with potential fertility are reluctant to use effective contraceptive measures during the whole trial cycle and within 14 days after the trial completion (or discontinue the trail in advance); Have any other conditions that, in the opinion of the Investigator, would prevent the subject from completing the study or present a significant risk to the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PLT; | — |
Countries
China
Contacts
Public ContactNiu Ting
West China Hospital,Sichuan University
Outcome results
None listed