Eltrombopag Combining Rituximab Versus Eltrombopag in the Management of Primary Immune Thrombocytopenia (ITP) in Adults

Inclusion Criteria:

1. Signed written informed consent

2. Age from 18 to 60 years old

3. Diagnosed with ITP and have a platelet count of <30 ×10^9/L on Day 1 (or within 48hours prior to dosing on Day 1).

4. Patients who have no response or relapsed after splenectomy(at least more than 6months). Or patients who have not been splenectomised and have either not responded toone or more prior therapies, or who have relapsed prior therapy.

5. Subjects treated with previous therapy(including but not limited to corticosteroid,azathioprine, danazol, cyclosporin A, mycophenolate mofetil) must have been completedprior to randomization, or must not be increasing a dose after enrollment.

6. No pre-existing cardiac disease within the last 3 months. No arrhythmia known toincrease the risk of thrombolic events (e.g. atrial fibrillation), or patients with aCorrected QT interval (QTc) >450msec or QTc >480 for patients with a Bundle BranchBlock.

7. No pre-existing infection within the last 1 months(including but not limited topulmonary infection)

8. Laboratory tests for coagulation function showed that prothrombin time (PT/INR) andactivated partial thromboplastin time (APTT) no exceed normal by more than 20%. Nohistory of clotting disorder, other than ITP.

9. White blood cell count, neutrophil absolute value, hemoglobin, within the referencerange, with the following exceptions:

• Hemoglobin: females and males 10.0 g/dl are eligible for inclusion,

• Absolute neutrophil count (ANC) ≥1500/µL (1.5×109/L) is required for inclusion

10. The following blood chemistry test result no exceed normal by more than 20%:alanineaminotransferase, aspartate aminotransferase, total bilirubin, creatinine,serumalbumin must not be below the lower limit of normal (LLN) by more than 10%.

11. Subject is non-childbearing potential of childbearing potential and use acceptablemethods of contraception throughout the study.

12. 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. Patients with any prior history of arterial or venous thrombosis, and with followingrisk factors: cancer, Factor V Leiden, ATIII deficiency, antiphospholipid syndrome.

2. Pregnant or lactating women;

3. Subjects is currently receiving treatment with another study medication.

4. Any laboratory or clinical evidence for HIV infection.

5. Any clinical history for hepatitis C infection; chronic hepatitis B infection; or anyevidence for active hepatitis at the time of subject screening. Laboratory test showspositive serology for Hepatitis C or Hepatitis B (HB). In addition, if negative forHBsAg but HBcAb positive (regardless of HBsAb status), a HB DNA test will be performedand if positive the subject will be excluded.

6. History of platelet aggregation that prevents reliable measurement of platelet counts.

7. Any clinically relevant abnormality, other than ITP,which in the opinion of theinvestigator makes the subject unsuitable for participation in the study.