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; theplatelet 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 relatedexaminations before enrollment(Bone marrow biopsy is valid for 30 days, including 30days);

5. The patient has been treated with splenectomy for relapse or relapse; or the patienthas not undergone splenectomy, but was ineffective or relapses after treatment with atleast 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 enrollmentor 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 havemaintained a stable therapeutic dose for at least the last month; patients whoreceived rituximab should be discontinued half a year prior to enrollment; patientswith 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) andactivated partial thromboplastin time (APTT) values did not exceed 20% of the normalreference range.No history of coagulation abnormalities except ITP;

10. White blood cell count, neutrophil absolute value, hemoglobin in the normalvalue.Except in the following cases: a) Platelet count <30×10^9/L within Day1 or Day1within 48 hours; b) Hemoglobin: if anemia is clearly caused by ITP (thrombocytopeniacaused blood loss), the lower limit of the subject's hemoglobin level below the normalvalue can be based on the investigator's judgment to decide the subject whether to beselected; 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 andalkaline phosphatase. In addition, serum albumin is not lower than the lower limit ofnormal value by 10%;

12. Subjects took an approved method of contraception. Female subjects (or female partnersof male subjects) must be infertile (hysterectomy, bilateral salpingectomy, bilateraltubal ligation or more than 1 year after menopause) or have fertility but before thefirst dose for 2 weeks, study-approved contraceptive methods were used throughout thestudy period to 28 days after the end of the study or discontinuation of thestudy.Male subjects with a fertile female partner must have undergone vasectomy orconsent to effective contraception throughout the study period (2 weeks prior to thefirst dose, throughout the study period, until the end of the study or 28 days afterthe discontinuation of the study) method;

13. Women with fertility must have a negative serum pregnancy test within 24 hours priorto the first dose;

14. Subjects fully understand and are able to comply with the requirements of the researchprotocol and are willing to complete the study as planned.

Exclusion Criteria:

1. Subjects had a history of any arterial/venous thrombosis (including stroke, transientischemic attack, myocardial infarction, deep vein thrombosis, or pulmonary embolism)and had at least 2 of the following risk factors: hormone replacement therapy, oralcontraception medicine (including estrogen), smoking, diabetes, hypercholesterolemia,drug-controlled hypertension, malignant tumors, hereditary coagulopathy;

2. Abnormalities other than ITP during the screening phase or any medical history orcondition that the investigator considered unsuitable for participation in the study;

3. Patients with BMI ≥ 28;

4. Pregnant or lactating women;

5. A history of alcohol/drug abuse within 12 months prior to screening or first dose;

6. Previous treatment with a specific study drug other than rhTPO or other researchtreatments;

7. The subject has previously received or is currently receiving treatment with exenatideor other thrombopoietin receptor agonists;

8. Throughout the study, medications that affected platelet function (including but notlimited to aspirin, clopidogrel and/or non-steroidal anti-inflammatory drugs NSAIDs)or anticoagulant therapy were continued for >3 days;

9. Accept any herbal or nutritional supplements, excluding vitamin supplements andmineral supplements within 1 week prior to the start of the study;

10. There is a history of abnormal platelet aggregation that may affect the reliability ofplatelet count measurements;

11. Before the first dose administration, the bone marrow biopsy showed abnormality exceptfor ITP within 4 weeks, and the investigator judged that the abnormality made thesubject unsuitable for the study, or the bone marrow biopsy showed other primarydisease which caused thrombocytopenia;

12. Evidence of all laboratory or clinical HIV infections, previous clinical history ofhepatitis C,hepatitis B, or active hepatitis at screening. Laboratory tests during thescreening period indicate hepatitis C infection or hepatitis B infection. (Defined asHBsAg test positive, in addition, if the HBsAg test is negative, but HBcAb ispositive, regardless of the status of HBsAb, HBV DNA testing is required, if positive,subjects should be excluded);

13. Rescuing treatment is required before the first dose of the drug.