The Tolerability，Safety，PK/PD Study of rhTPO in the Patients With Liver Function Impairment

Inclusion Criteria:

• 1. Patients with cirrhosis caused by chronic liver disease who have been diagnosed bybiopsy/imaging (Child-Pugh class A, B, and C).
• 2. Life expectancy≥3 months.
• 3. Platelet count≤80×109/ L.
• 4. Fertile female subjects with a negative pregnancy test during the screening periodand who agree to take effective contraceptive methods Throughout the study period willbe eligible for this study.
• 5. Voluntary written informed consent.

Exclusion Criteria:

• 1 Subjects allergic to any component of investigational drug.

• 2 Subjects with cirrhosis caused by drug-induced liver injury.

• 3 Subjects with history of splenectomy or liver transplantation.

• 4 Liver cirrhosis with serious complications, including: hepatic encephalopathy,intractable ascites, upper gastrointestinal bleeding, etc.

• 5 Subjects with Liver failure.

• 6 Tthe presence of portal vein thrombosis or tumor thrombus was indicated by dopplerultrasound or CT or MRI and other imaging examinations within 3 months prior to thebeginning of screening.

• 7 Subjects with history of arterial or venous thromboembolism, or with thromboembolicdisease, or with high risk factors for thrombosis, or with a hereditary tendency tothrombosis, including Antithrombin III deficiency, etc.

• 8 Subjects with history of any disease other than chronic liver disease and cirrhosisthat may result in decreased platelet count and/or abnormal platelet function,including aplastic anemia, myelodysplastic syndrome (MDS), bone marrow fibrosis, etc.;

• 9 Subjects with diseases with higher bleeding risk, such as coagulation factordeficiency or Vascular pseudohemophilia factor deficiency.

• 10 Subjects with severe infections that are not effectively controlled.

• 11 Past or present history with any serious disease except liver disease, including:angina, severe arrhythmia, myocardial infarction, heart failure, Cerebral hemorrhage,cerebral infarction, intracranial infection, Renal insufficiency( creatinine clearancerate ≤50 mL/min )，as well as any other diseases that have been judged by investigatorto be unsuitable for this study.

• 12 Subjects who had undergone trans jugular intrahepatic portal shunt (TIPS);

• 13 Subjects with Anti-HIV positive antibodies or Anti- TPHA positive antibodies.

• 14 Subjects who received any therapy with increased platelet count within the 3 weeksor platelet transfusion within 2 weeks before randomization.

• 15 No more than 30 days or 5 half-lives after investigational drug treatment for otherstudies (whichever is longer).

• 16 Subjects with history of primary liver cancer, or an other malignant tumor.

• 17 patients with WHO≥grade 2 of existing active bleeding, or with history of activebleeding within 2 weeks before randomization.

• 18 Pregnant or breast-feeding women.

• 19 Women who have a pregnancy plan within 3 months.

• 20 Subjects with history of drug abuse and alcoholism within 6 months prior toenrollment.

• 21 Subjects who do not have the sufficient ability of understanding，communication andcooperation leading to failure to ensure compliance with protocol will be excluded.