ITP
Conditions
Interventions
Experimental group:Romiplostin N01 (initial dose of 3 µg/kg, administered subcutaneously once a week) combined with glucocorticoids (high-dose dexamethasone 40 mg/day for 4 days or conventional-dose p
Sponsors
Subei People's Hospital of Jiangsu province.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old, gender not restricted; 2. Before enrollment, the clinical diagnosis was primary immune thrombocytopenia. The platelet count within 48 hours before the first administration of the study drug was less than 30 × 10^9/L; 3. Patients who have not received any treatment plan for ITP; 4. Prothrombin time does not exceed the normal range by ±3 seconds, and activated partial thromboplastin time does not exceed the normal range by ±10 seconds; apart from ITP, there is no history of other coagulation disorders; 5. Voluntary to sign the informed consent form in person;
Exclusion criteria
Exclusion criteria: 1. Myelodysplastic syndrome, immune disorders such as systemic lupus erythematosus, early aplastic anemia, atypical aplastic anemia, antiphospholipid syndrome, thrombotic thrombocytopenic purpura and other secondary thrombocytopenias caused by various reasons; 2. 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; 3. Within 3 months before screening, the patient has suffered from heart disease, including NYHA class III/IV congestive heart failure, arrhythmias requiring drug treatment or myocardial infarction, or known arrhythmias that increase the risk of thrombotic events (such as atrial fibrillation), or the corrected QT interval (QTc) is prolonged (QTc > 450 milliseconds, or for patients with bundle branch block, QTc > 480 milliseconds); 4. Within 3 months before screening, the patient has participated in other clinical trials; 5. Within 2 weeks before screening, the patient has continuously used drugs that affect platelet function (including but not limited to aspirin, aspirin-containing complexes, clopidogrel, salicylates, and/or non-steroidal anti-inflammatory drugs NSAIDs) or anticoagulant treatment for more than 3 days; 6. The bone marrow biopsy results during the screening period suggest bone marrow fibrosis MF >= 2 (European expert consensus bone marrow fibrosis scoring criteria Thieleja 2005), or the bone marrow biopsy indicates the presence of other primary diseases that can cause thrombocytopenia except ITP; 7. During the screening period, the patient has HIV infection or positive hepatitis C antibody (if the hepatitis B surface antigen is positive, or the hepatitis B surface antigen is negative but the hepatitis B core antibody is positive, HBV-DNA testing is required, if it indicates viral replication, the patient should be excluded); 8. During the screening period, alanine aminotransferase (ALT), aspartate aminotransferase (AST) are more than 1.5 times the upper limit of normal, total bilirubin, serum creatinine are more than 1.2 times the upper limit of normal; 9. History of liver cirrhosis or portal hypertension; 10. History of malignant tumor or accompanied by malignant tumor; 11. Pregnant or lactating women; 12. Patients with potential fertility who do not wish to use effective contraceptive measures throughout the trial period and 14 days after the end of the trial (or prematurely terminate the trial); 13. The investigator considers that there are any other conditions that may prevent the subject from completing this study or bring obvious risks to the subject.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients who achieved platelet response (platelet count > = 30×10^9/L after treatment, at least 2 times higher than the basal platelet count, and no bleeding manifestations) at 2 weeks, 4 weeks, 12 weeks, and 16 weeks;;Response time to treatment; | — |
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients who achieved platelet response (platelet count >= 30x10^9/L after treatment, at least 2-fold increase over basal platelet count, and no bleeding manifestations) after 8 weeks of treatment; | — |
Countries
China
Contacts
Public ContactMei Sun
Subei People's Hospital of Jiangsu province.
Outcome results
None listed