Evaluate the Safety and Efficacy of STSG-0002 Injection in Patients With Chronic Hepatitis B
Reason given: The preliminary effectiveness data observed at present did not meet the expectations, the benefit of the subjects receiving the experimental drug was limited.
Key facts
- Where
- Beijing and Chongqing, ChinaSee the 4 sites
- Phase
- Phase 2
Where in China
- Beijing Youan Hospital,Capital MedicalBeijing, ChinaNo longer taking part
- Peking University First HospitalBeijing, ChinaNo longer taking part
- Peking University People's HospitalBeijing, ChinaNo longer taking part
- The Second Affiliated Hospital of Chongqing MedicalChongqing, ChinaNo longer taking part
Trial details
- Who runs it
- Staidson (Beijing) Biopharmaceuticals Co., Ltd
- Trial code
- NCT05760703
- Record updated
- 19 December 2023
- Original description
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).Read full original descriptionShow less
Phase Ib/II: Multicenter, Open, Dose-escalation Evaluation of the Safety and Efficacy of STSG-0002 Injection in Patients With Chronic Hepatitis B Treated With Oral Antiviral Therapy(Long-term Follow-up)
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).
Inclusion: Patients with chronic HBV；; Receiving anti-HB viral therapy；; 10 IU/ml≤HBsAg≤3000 IU/ml.
Exclusion: Patients co-infected with hepatitis C virus, HIV, HAV, HDV, HEV; Autoimmune liver disease; 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; Liver cirrhosis; Hepatocellular carcinoma; Clinical hepatic decompensation; Fibroscan>12 kPa.