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

Más betegség

• 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);
• 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);
• History of severe psychiatric disease;
• History of a severe seizure disorder or current anticonvulsant use;
• History of immunologically mediated disease, (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, rheumatoid arthritis etc.);
• History of chronic pulmonary disease associated with functional limitation;
• Diseases that IFN and Nucleotides or nucleosides are not suitable.

Laborértékek

• ALT >10 ULN;
• Neutrophil count < 1500 cells/mm3 or platelet count <90,000 cells/mm3 at screening;
• Hemoglobin < 11.5 g/dL for females and <12.5 g/dL for men;
• Serum creatinine level > 1.5 ULN in screening period.
• Phosphorus < 0.65 mmol/L;

Egyéb

• Patients who had NAs resistance;
• Other antiviral, anti-neoplastic or immunomodulatory treatment;
• Women with ongoing pregnancy or breast-feeding;
• LSM >9kPa ;
• Signs or symptoms of hepatocellular carcinoma;
• ANA > 1:100;

• Male and female patients from 18 to 65 years of age;
• Chronic hepatitis B infection
• 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;
• Agree to participate in the study and sign the patient informed consent.