A Study to Assess Efficacy and Safety of HH-003 Injection in Subjects With Chronic Hepatitis Delta Virus Infection

Exclusion Criteria

• •Subjects with known hypersensitivity to HH-003 and its components, history of severe allergic reaction to other therapeutic antibodies or severe allergic diseases;
• •Subjects with contraindications for TAF;
• •History of interferon therapy within 3 months before randomization;
• •Any of the following lab test results at screening:
• •1. Total bilirubin \>2×ULN (except for subjects with Gilbert syndrome);
• •2. Direct bilirubin \> 1.5×ULN ;
• •3. Platelets\<80,000/mm3 (80×109/L);
• •4. Serum Albumin \<35 g/L;
• •5. Prothrombin time international normalized ratio (INR) \>1.3;
• •6. Hemoglobin \<100 g/L;
• •7. Absolute neutrophils\<1,500/mm3 (1.5×109/L);
• •8. Estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73m2 (according to the calculation equation of CKD-MDRD);
• •Concomitant decompensated cirrhosis (cirrhosis with complications of portal hypertension and/or decreased hepatic function). The diagnosis of cirrhosis is based on, but not limited to: liver imaging assessment within 6 months prior to randomization (including screening period) (e.g.: liver ultrasound) or cirrhosis indicated by histopathology of liver biopsy, or liver stiffness measurement LSM≥17 kPa at screening, refer to more serious reported findings;
• •Hepatic insufficiency within 3 months prior to randomization (including but not limited to: ascites, hepatic encephalopathy, upper gastrointestinal hemorrhage);
• •Previous or current hepatocellular carcinoma (HCC) or suspicion for HCC suggested by liver histopathology or liver imaging; or serum alpha-fetoprotein (AFP) ≥ 50 ng/mL at screening;
• •Subjects with history of alcoholic liver disease, nonalcoholic steatohepatitis, autoimmune liver disease or other hereditary liver diseases, drug-induced liver disease or other clinically significant chronic liver diseases not caused by HDV/HBV;
• •History of other malignancies other than HCC, unless the subject's malignancy has been in complete remission within 3 years prior to screening and does not require chemotherapy and additional medical or surgical intervention; invasive medical devices within 1 month before randomization.