primary immune thrombocytopenia
Conditions
Interventions
Experiment group:Intravenous Human Immunoglobulin (pH4, 10%) (Chromatography)
Sponsors
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. 18 to 65 years of age (including 18 and 65 years old), male or female; 2. At least 3 months from clinically diagnosis as primary immune thrombocytopenia to signing informed consent; 3. As of screening, patients who have been using fixed doses of glucocorticoids for two weeks or more or who have not used glucocorticoids for at least two weeks; 4. Blood platelet count < 30 x 10^9/L; 5. Able to understand the procedures and methods of this study, willing to sign informed consent form and strictly abide by the clinical protocol to complete this study; 6. Agree to take effective contraceptive measures during the trial and within 3 months after the end of the last administration.
Exclusion criteria
Exclusion criteria: 1. Refractory ITP (according to "Consensus of Chinese experts on diagnosis and treatment of adult primary immune thrombocytopenia" (Verson 2016); 2. Known or suspected to allergy to or have serious adverse reactions to human immunoglobulin or steroid hormone, or have allergic constitution; 3. Received rituximab within 3 months before enrollment; 4. Received immunosuppressive agent (such as azathioprine, cyclosporine A, cyclophosphamide, vincristine, mycophenolate mofetil, danazol, etc., except glucocorticoids), TPO or other drugs that have the confirmed effect of improving platelet count (such as TPO receptor agonist (receptor agonist Qubopa, Romistine, etc.), IL-11, platelet-ascending capsule, Weixuening, etc.) within 4 weeks before screening; 5. Received blood transfusion or blood products including human immunoglobulin within 30 days before screening; 6. Planning to receive blood transfusion or other blood products during the trial period; 7. Acute bacterial or acute viral infection that still need to be treated with antibiotics after enrollment; 8. Uncontrollable hypertension (SBP > 160mmHg and/or DBP > 100mmHg); 9. Hemoglobin 2 times of the upper limit of normal range, or total bilirubin > 1.5 times of the upper limit of normal range, or Cr > 1.5 times of the upper limit of normal range, if any one is satisfied); 11. History of selective IgA deficiency; 12. Positive for hepatitis B surface antigen, hepatitis C antibody, syphilis antibody or HIV antibody; 13. Splenectomy or plan to undergo splenectomy; 14. Previously failed with immunoglobulin therapy; 15. Immune haemolytic anaemia or any previous history of arterial/venous thrombosis (including stroke, transient ischemic attack, myocardial infarction, pulmonary embolism, deep vein thrombosis, etc.); 16. Tendency of drug abuse or drug dependence, history of mental disorder or mental disorder with suicidal tendency; 17. Pregnant and lactating female; 18. Have participated in other clinical trials within 1 month; 19. The investigator judged that the patient's compliance was likely to be affected by the unstable condition of the disease, or the investigator judged that the patient should not participate in the study for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total response rate of patients within 7 days after treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients with platelet count (PLT) above 50 x 10^9/L within 7 days after treatment;Time to the first achievement of platelet count >= 50 x 10^9/L within 7 days after treatment;Percentage of patients with PLT >= 100 x 10^9/L within 7 days after treatment;Time to the first achievement of platelet count >= 100 x 10^9/L within 7 days after treatment;Total response rate of patients at 14, 21, 28 days after treatment;Bleeding scores within 7 days and at 14, 21, and 28 days after treatment; | — |
Countries
China
Contacts
Public ContactLei Zhang
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Outcome results
None listed