To Evaluate the Safety and Efficacy of STSG-0002 Injection in Patients With Chronic Hepatitis B
NCT ID: NCT05760781
Last Updated: 2023-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
9 participants
INTERVENTIONAL
2023-04-25
2023-12-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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lowest dose treatment group
Subjects will receive one single lowest dose of STSG-0002 Injection following protocol requirements
STSG-0002 Injection
Intravenous infusion
low dose treatment group
Subjects will receive one single low dose of STSG-0002 Injection following protocol requirements
STSG-0002 Injection
Intravenous infusion
Intermediate dose treatment group
Subjects will receive one single intermediate dose of STSG-0002 Injection following protocol requirements
STSG-0002 Injection
Intravenous infusion
A single high dose of treatment group
Subjects will receive one single high dose of STSG-0002 Injection following protocol requirements
STSG-0002 Injection
Intravenous infusion
Interventions
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STSG-0002 Injection
Intravenous infusion
Eligibility Criteria
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Inclusion Criteria
* Receiving anti-HB viral therapy;
* 10 IU/ml≤HBsAg≤3000 IU/ml.
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Beijing Sanuo Jiayi Biotechnology Co. LTD
UNKNOWN
Staidson (Beijing) Biopharmaceuticals Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Guiqiang Wang
Role: PRINCIPAL_INVESTIGATOR
Peking University First Hospital
Locations
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Peking University First Hospital
Beijing, Beijing Municipality, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
Beijing Youan Hospital,Capital Medical
Beijing, Beijing Municipality, China
The Second Affiliated Hospital of Chongqing Medical
Chongqing, Chongqing Municipality, China
Countries
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Other Identifiers
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STS-STSG0002-002
Identifier Type: -
Identifier Source: org_study_id