A Randomized Trial Comparing Optimized rhTPO Treatment With Eltrombopag Treatment in Pre-treated ITP Pts

Comparing the Efficacy and Safety of Optimized rhTPO Treatment Versus Eltrombopag Treatment in Previously Treated Primary Immune Thrombocytopenia Patients: A Multicenter Randomized Open-label Trial

TE-ITP study: Compare the efficacy and safety of optimized rhTPO treatment versus Eltrombopag treatment in previously treated primary immune thrombocytopenia patients.

A multicenter randomized open-label trial to compare the efficacy and safety of an optimized rhTPO treatment versus Eltrombopag treatment in previously treated primary immune thrombocytopenia. Total treatment duration is 6 weeks, the primary endpoint is "median time to achieve platelet count ≥50x10^9/L during 6 weeks observation".

Inclusion Criteria:

• Subject is ≥18 years old.
• Disease duration is ≥3 months, diagnosed and treated as ITP prior to screening.
• Baseline platelet count <30×10^9/L.
• Subjects treated with maintenance corticosteroids or immunosuppressive therapy must be receiving a dose that has been stable for at least 1 month.
• Informed consent has been signed.

Exclusion Criteria:

• Classified as refractory ITP.
• Subjects with any prior history of arterial or venous thrombosis, or thrombophilia in recent 1 year.
• Subjects who have previously received any platelet increasing drug such as rhTPO, thrombopoietin receptor agonist(TPO-RA), etc. within 30 days.
• Subjects who are known nonresponders to rhTPO or TPO-RA therapy.
• Subjects with positive hepatitis C virus antibody or human immunodeficiency virus(HIV) antibody, positive HBsAg and serum levels of hepatitis B virus (HBV) DNA >1000cps/ml.
• TBil or Scr> 1.5 x upper limit of normal (ULN), ALT or AST> 3.0 x ULN in recently 2 weeks.
• Subjects with any prior history of tumor.
• Female subjects who are nursing or pregnant.
• Any situation that investigate consider not suitable for pts to join the study.