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The objective of this study was to evaluate the efficacy and safety of TVAX-008 Injection in a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase II clinical trial in NAs-treated subjects with chronic hepatitis B. 80 subjects are planned to be enrolled in this study and divided into 2 groups. After a screening period of no more than 4 weeks, eligible subjects will be randomly assigned to enter the double-blind treatment period according to the ratio of 1:1, and receive TVAX-008 injection or placebo in combination with NAs for 24 weeks. At the end of the double-blind treatment period, subjects with HBsAg negative and HBsAg>100 mIU/mL continued to be followed up to Week 73; subjects with HBsAg not negative or HBsAg negative but HBsAg ≤100 mIU/mL entered the open-label treatment period and received TVAX-008 injection combined with NAs for 24 weeks, and continued to be followed up for 24 weeks after the end of the open-label treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TVAX-008 | Experimental | TVAX-008 |
|
| placebo | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TVAX-008 | Drug | TVAX-008 |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| HBsAg negative conversion rate | HBsAg negative conversion rate | week37 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University first hospital | Beijing | 10000 | China |
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| Drug |
Placebo |
|
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| 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 |
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