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），plateletbilirubin>1.5 ×ULN，ALT>2 × ULN，serum albumin<35 g/L；c. INR>1.5；d. serum creatinine >1.5×ULN.