Primary immune thrombocytopenia
Conditions
Interventions
Treatment group:Herombopag Olamine Tablets
Sponsors
Southern Medical University Southern Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old, gender not limited; 2. Diagnose patients with primary immune thrombocytopenia; 3. Those who have not received any treatment or have only received effective hormone and/or immunoglobulin treatment after diagnosis; 4. Two consecutive tests within two weeks prior to enrollment (with an interval of at least 48 hours) with platelet count= 2); 5. The subject agrees to participate and signs an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Secondary thrombocytopenia caused by myelodysplastic syndrome, immune disorders such as systemic lupus erythematosus, early aplastic anemia, atypical aplastic anemia, antiphospholipid syndrome, thrombotic thrombocytopenic purpura, and other various reasons; 2. Screening for treatment with chemotherapy, anticoagulant drugs, or other drugs that affect platelet count within the previous 6 months; 3. Have received treatment with TPO drugs (such as ezetimibe and recombinant human thrombopoietin) and the treatment has been ineffective; 4. Received treatment with ITP related drugs other than immunoglobulin and glucocorticoids (such as rituximab, cyclophosphamide, 6-mercaptopurine, vincristine, etc.); 5. HIV infection or hepatitis C antibody positive in the screening period (if the hepatitis B B surface antigen is positive, or the hepatitis B B surface antigen is negative but the hepatitis B core antibody is positive, HBV-DNA test is required, and if there is virus replication, the subject should be excluded); 6. During the screening period, the levels of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were greater than 3 times the upper limit of normal values, and the levels of total bilirubin and serum creatinine were greater than 1.5 times the upper limit of normal values; 7. History of malignant tumors or accompanying malignant tumors; 8. The patient has experienced 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; 9. Screening for heart disease occurring within the previous 3 months, including heart failure, arrhythmia requiring medication, or myocardial infarction; 10. Bone marrow fibrosis MF>2 (Thieleja 2005, European expert consensus bone marrow fibrosis scoring standard); 11. Pregnant or lactating women; 12. The researcher believes that there are any other circumstances that may prevent the subject from completing the study or pose significant risks to the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with two consecutive platelet counts >= 30 × 10^9/L and an increase of at least 2 times compared to baseline without salvage treatment in weeks 11-12; | — |
Secondary
| Measure | Time frame |
|---|---|
| Initial efficacy rate: proportion of subjects who achieved platelet response after 4 weeks of treatment;Effective time: the time required from the start of treatment to the onset of platelet response;Long term remission rate: proportion of subjects who experienced sustained remission at 24 and 52 weeks after discontinuation of medication;Duration of therapeutic effect: from onset to recurrence or end of study;The proportion of subjects who achieved complete response after starting treatment;According to the WHO bleeding scoring criteria, the incidence and severity of bleeding symptoms;Safety: Evaluate the safety of drugs according to NCI-CTCAE 5.0 standards;SF-36 Life Scale; | — |
Countries
China
Contacts
Public ContactJieyu Ye
Southern Medical University Southern Hospital
Outcome results
None listed