Combination of ETV, TQ-A3334 and TQ-B2450 for CHB (Neptune Study)

Launched by TONGJI HOSPITAL · Dec 15, 2019

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male and female patients from 18 to 65 years of age;
• • 2. Chronic hepatitis B infection
• • 3. Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of test drug;
• • 4. Agree to participate in the study and sign the patient informed consent.
• Exclusion Criteria:
• • 1. Patients who had NAs resistance;
• • 2. Other antiviral, anti-neoplastic or immunomodulatory treatment;
• • 3. Women with ongoing pregnancy or breast-feeding;
• • 4. Co-infection with active hepatitis A, hepatitis C, hepatitis D(Those hospitals which have the ability to do the test will do) and/or human immunodeficiency virus (HIV);
• • 5. ALT \>10 ULN;
• • 6. LSM \>9kPa ;
• • 7. History or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures, thalassemia);
• • 8. Signs or symptoms of hepatocellular carcinoma;
• • 9. Neutrophil count \< 1500 cells/mm3 or platelet count \<90,000 cells/mm3 at screening;
• • 10. Hemoglobin \< 11.5 g/dL for females and \<12.5 g/dL for men;
• • 11. Serum creatinine level \> 1.5 ULN in screening period.
• • 12. Phosphorus \< 0.65 mmol/L;
• • 13. ANA \> 1:100;
• • 14. History of severe psychiatric disease;
• • 15. History of a severe seizure disorder or current anticonvulsant use;
• • 16. History of immunologically mediated disease, (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, rheumatoid arthritis etc.);
• • 17. History of chronic pulmonary disease associated with functional limitation;
• • 18. Diseases that IFN and Nucleotides or nucleosides are not suitable.