To Evaluate the Safety and Efficacy of STSG-0002 Injection in Patients With Chronic Hepatitis B
Chronic Hepatitis b
About this trial
This is an interventional treatment trial for Chronic Hepatitis b
Eligibility Criteria
Inclusion Criteria: Patients with chronic HBV; Receiving anti-HB viral therapy; 10 IU/ml≤HBsAg≤3000 IU/ml. Exclusion Criteria: Patients co-infected with hepatitis C virus, HIV, HAV, HDV, HEV; Liver cirrhosis; Hepatocellular carcinoma; Autoimmune liver disease; Clinical hepatic decompensation; Fibroscan>12 kPa; a. hemoglobin<110g/L(female)<120 g/L(male),platelet<ULN,white blood cell<2.5×109/L;b. bilirubin>1.5 ×ULN,ALT>2 × ULN,serum albumin<35 g/L;c. INR>1.5;d. serum creatinine >1.5×ULN.
Sites / Locations
- Peking University First HospitalRecruiting
- Peking University People's Hospital
- Beijing Youan Hospital,Capital Medical
- The Second Affiliated Hospital of Chongqing Medical
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
lowest dose treatment group
low dose treatment group
Intermediate dose treatment group
A single high dose of treatment group
Subjects will receive one single lowest dose of STSG-0002 Injection following protocol requirements
Subjects will receive one single low dose of STSG-0002 Injection following protocol requirements
Subjects will receive one single intermediate dose of STSG-0002 Injection following protocol requirements
Subjects will receive one single high dose of STSG-0002 Injection following protocol requirements