Multicentre, Randomised Phase III Study of the Efficacy and Safety of Hetrombopag Olamine in Idiopathic Thrombocytopenic Purpura (ITP) Patient

Inclusion criteria

• Confirmed diagnosis of ITP ≥6 months;Platelets <30×109/L.
• No evidence of other causes of thrombocytopenia.
• Subjects who are refractory or have relapsed after at least one prior ITP therapy.
• Previous therapy for ITP including rescue must have been completed at least 2 weeks prior to randomization.
• Subjects treated with maintenance immunosuppressive therapy must be receiving a dose that has been stable for at least 1 month.
• PT result no exceed normal by more than ±3s,APTT result no exceed normal by more than ±10s.
• Signed informed consent.

Exclusion criteria

• Patients with any prior history of arterial or venous thrombosis，or diagnosis as Thrombophilia.
• Subjects diagnosed with tumor.
• Have pre-existing cardiac disease within the last 3 months.No arrhythmia known to increase the risk of thrombolic events (e.g. atrial fibrillation), or patients with a Corrected QT interval (QTc) >450msec or QTc >480 for patients with a Bundle Branch Block.
• Female subjects who are nursing or pregnant at screening or pre-dose on baseline.
• Subjects who have previously received eltrombopag or any other thrombopoietin receptor agonist within 30 days .
• Subject has consumed aspirin, aspirin-containing compounds, salicylates, anticoagulants, quinine or non-steroidal anti-inflammatories (NSAIDs) for >3 consecutive days within 2 weeks of the study start and until the end of the study.
• Any laboratory or clinical evidence for HIV infection.Any clinical history for hepatitis C infection; chronic hepatitis B infection; or any evidence for active hepatitis at the time of subject screening.
• ALT> 1.5 x upper limit of normal (ULN), AST> 3 x upper limit of normal (ULN)) DBLI> 1.2 x upper limit of normal (ULN),Scr> 1.2 x upper limit of normal (ULN)
• The subject has participated in other clinical trial within the 3 months prior to randomization.