Efficacy and Safety of rhTPO and Eltrombopag in Patients With Primary Immune Thrombocytopenia (ITP)

Inclusion Criteria

• •1. The patient signs an informed consent form.
• •2. Age from 18 to 75 years old
• •3. The patient's first diagnosis of ITP is at least 6 months before enrollment; the platelet count must \<30×109/L before taking the study drug (48 hours before).
• •4. Patients who were diagnosed with ITP by bone marrow biopsy and other related examinations before enrollment(Bone marrow biopsy is valid for 30 days, including 30 days);
• •5. The patient has been treated with splenectomy for relapse or relapse; or the patient has not undergone splenectomy, but was ineffective or relapses after treatment with at least one first line drug. Past ITP therapy can include, but is not limited to, corticosteroids, immunoglobulins (IVIG or anti-D Immunoglobulin), azathioprine, danazol, cyclophosphamide and immunomodulators;
• •6. Previous salvage treatments included infusion of platelets, immunoglobulins, immunomodulators, and cyclophosphamide must be completed 2 weeks prior to enrollment or treatment. Corticosteroids must end at least 14 days before enrollment.
• •7. Patients receiving immunosuppressive agents (including corticosteroids, azathioprine, danazol, cyclosporin A, mycophenolate mofetil) or proprietary Chinese medicines have maintained a stable therapeutic dose for at least the last month; patients who received rituximab should be discontinued half a year prior to enrollment; patients with spleen were enrolled six months after surgery;
• •8. No heart disease in the past 3 months, including NYHA grade III/IV charge
• •, heart failure, arrhythmia or myocardial infarction requiring medical treatment;
• •9. Laboratory tests for coagulation function showed that prothrombin time (PT/INR) and activated partial thromboplastin time (APTT) values did not exceed 20% of the normal reference range.No history of coagulation abnormalities except ITP;
• •10. White blood cell count, neutrophil absolute value, hemoglobin in the normal value.Except in the following cases: a) Platelet count \<30×10\^9/L within Day1 or Day1 within 48 hours; b) Hemoglobin: if anemia is clearly caused by ITP (thrombocytopenia caused blood loss), the lower limit of the subject's hemoglobin level below the normal value can be based on the investigator's judgment to decide the subject whether to be selected; c) absolute neutrophil count ≥ 1.5 × 109 / L can be enrolled;
• •11. The following clinical biochemical indicators must be within 20% of the normal range: creatinine, alanine aminotransferase, aspartate aminotransferase, total bilirubin and alkaline phosphatase. In addition, serum albumin is not lower than the lower limit of normal value by 10%;
• •12. Subjects took an approved method of contraception. Female subjects (or female partners of male subjects) must be infertile (hysterectomy, bilateral salpingectomy, bilateral tubal ligation or more than 1 year after menopause) or have fertility but before the first dose for 2 weeks, study-approved contraceptive methods were used throughout the study period to 28 days after the end of the study or discontinuation of the study.Male subjects with a fertile female partner must have undergone vasectomy or consent to effective contraception throughout the study period (2 weeks prior to the first dose, throughout the study period, until the end of the study or 28 days after the discontinuation of the study) method;
• •13. Women with fertility must have a negative serum pregnancy test within 24 hours prior to the first dose;
• •14. Subjects fully understand and are able to comply with the requirements of the research protocol and are willing to complete the study as planned.