Chronic Hepatitis b
Conditions
Brief 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).
Interventions
Intravenous infusion
Sponsors
Beijing Sanuo Jiayi Biotechnology Co. LTD
Staidson (Beijing) Biopharmaceuticals Co., Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of subjects of adverse events | Baseline to Day 180 |
| Number of subjects With Significant Abnormal Physical Examination | Baseline to Day 180 |
| Number of subjects of Significant Abnormal Vital Signs Findings | Baseline to Day 180 |
| Number of Participants With Significant Abnormal Laboratory Values | Baseline to Day 180 |
| Number of subjects With Significant Abnormal Electrocardiography (ECG) Findings | Baseline to Day 180 |
Countries
China
Outcome results
None listed