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The preliminary effectiveness data observed at present did not meet the expectations, the benefit of the subjects receiving the experimental drug was limited.
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| Name | Class |
|---|---|
| Beijing Sanuo Jiayi Biotechnology Co. LTD | UNKNOWN |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lowest dose treatment group | Experimental | Subjects will receive one single lowest dose of STSG-0002 Injection following protocol requirements |
|
| low dose treatment group | Experimental | Subjects will receive one single low dose of STSG-0002 Injection following protocol requirements |
|
| Intermediate dose treatment group | Experimental | Subjects will receive one single intermediate dose of STSG-0002 Injection following protocol requirements |
|
| A single high dose of treatment group | Experimental | Subjects will receive one single high dose of STSG-0002 Injection following protocol requirements |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STSG-0002 Injection | Drug | Intravenous infusion |
|
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guiqiang Wang | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | Beijing Municipality | 100032 | China | ||
| Peking University People's Hospital |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| Beijing |
| Beijing Municipality |
| 100044 |
| China |
| Beijing Youan Hospital,Capital Medical | Beijing | Beijing Municipality | 100069 | China |
| The Second Affiliated Hospital of Chongqing Medical | Chongqing | Chongqing Municipality | 401437 | China |
| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |