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

Chronic Hepatitis b Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05760703
• Other study ID #: STS-STSG0002-002-LTFU
• Status: Terminated
• Phase: Phase 2
• Start date: April 25, 2023
• Est. completion date: December 11, 2023

Study information

• Verified date: December 2023
• Source: Staidson (Beijing) Biopharmaceuticals Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: December 11, 2023
• Est. primary completion date: December 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Hepatitis b
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• STSG-0002 Injection
Intravenous infusion

Locations

Country	Name	City	State
China	Beijing Youan Hospital,Capital Medical	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	Peking University People's Hospital	Beijing	Beijing
China	The Second Affiliated Hospital of Chongqing Medical	Chongqing	Chongqing

Sponsors (2)

Lead Sponsor	Collaborator
Staidson (Beijing) Biopharmaceuticals Co., Ltd	Beijing Sanuo Jiayi Biotechnology Co. LTD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects of adverse events		Baseline to Day 180
Primary	Number of subjects With Significant Abnormal Physical Examination		Baseline to Day 180
Primary	Number of subjects of Significant Abnormal Vital Signs Findings		Baseline to Day 180
Primary	Number of Participants With Significant Abnormal Laboratory Values		Baseline to Day 180
Primary	Number of subjects With Significant Abnormal Electrocardiography (ECG) Findings		Baseline to Day 180