Hetrombopag or Placebo in Treatment-Naive Severe Aplastic Anemia

Exclusion Criteria

• •1. Diagnosis of whole blood cell reduction due to other causes or bone marrow hypoproliferative diseases.
• •2. Subjects who have previously received immunosuppressive therapy with mycophenolate mofetil, sirolimus, high dose cyclophosphamide (≥45mg/kg/d), alemtuzumab, etc；or have treated with thrombopoietin receptor agonist (eg, eltrombopag, romiplostim, rhTPO, etc.) prior to randomization.
• •3. Previous history of hematopoietic stem cell transplantation.
• •4. Subjects who is known or suspected of contraindications or hypersensitivity to Hetrombopag's API (Active Pharmaceutical Ingredient).
• •5. Evidence of clonal cytogenetic abnormalities at the time of screening.
• •6. Bleeding and/or Infection not adequately responding to appropriate therapy.
• •7. 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 subjects screening.
• •8. ALT\> 2.5 x upper limit of normal (ULN), AST\> 2.5 x upper limit of normal (ULN) DBLI\> 1.5 x upper limit of normal (ULN), Scr\> upper limit of normal (ULN).
• •9. Subjects with uncontrolled hypertension (\>180/100mmHg), severe arrhythmia (such as complete left bundle branch block, QT interval prolongation (Bazetts formula), torsade ventricular tachycardia, etc.), unstable angina, pulmonary hypertension at the time of screening.
• •10. Subjects diagnosed with cirrhosis or portal hypertension.
• •11. Subjects with malignant solid tumors of any organ system within 5 years prior to screening, with or without treatment, metastasis or recurrence, except for local cutaneous basal cell carcinoma; subjects with hematological tumors found previously or during screening.
• •12. Subjects with deep vein thrombosis, myocardial infarction, stroke or peripheral arterial embolization within 12 months prior to randomization.
• •13. Female subjects who are nursing or pregnant.
• •14. Subjects cannot comply with effective contraception.
• •15. Subjects have participated in other clinical trial within the 3 months prior to study entry.