Overview

Evaluate the Safety and Efficacy of STSG-0002 Injection in Patients With Chronic Hepatitis B

Status:
Not yet recruiting
Trial end date:
2029-03-01
Target enrollment:
0
Participant gender:
All
Summary
This trial is a multi-center, open, single-dose, dose-increasing trial,to evaluate the safety and efficacy of STSG-0002 injection in patients with chronic hepatitis B treated with oral antiviral therapy(Long-term follow-up).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Staidson (Beijing) Biopharmaceuticals Co., Ltd
Collaborator:
Beijing Sanuo Jiayi Biotechnology Co. LTD
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 bilirubin>1.5 ×ULN,ALT>2 × ULN,serum albumin<35 g/L;c. INR>1.5;d. serum creatinine
>1.5×ULN.