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

This is an interventional treatment trial for Liver Cirrhosis Read More

Inclusion Criteria:

• 1. Patients with cirrhosis caused by chronic liver disease who have been diagnosed by biopsy/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 period and who agree to take effective contraceptive methods Throughout the study period will be 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 doppler ultrasound or CT or MRI and other imaging examinations within 3 months prior to the beginning of screening.
• 7 Subjects with history of arterial or venous thromboembolism, or with thromboembolic disease, or with high risk factors for thrombosis, or with a hereditary tendency to thrombosis, including Antithrombin III deficiency, etc.
• 8 Subjects with history of any disease other than chronic liver disease and cirrhosis that 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 factor deficiency 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 clearance rate ≤50 mL/min )，as well as any other diseases that have been judged by investigator to 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 weeks or platelet transfusion within 2 weeks before randomization.
• 15 No more than 30 days or 5 half-lives after investigational drug treatment for other studies (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 active bleeding 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 to enrollment.
• 21 Subjects who do not have the sufficient ability of understanding，communication and cooperation leading to failure to ensure compliance with protocol will be excluded.