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This is a randomized, open-label, multicenter phase II study to evaluate the efficacy and safety of BW-20507 in combination with PEG-IFNα in CHB patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | BW-20507 with/without NUC |
|
| Cohort 2 | Experimental | BW-20507 with/without NUC, Peg-IFNa |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BW-20507 with/without NUC | Drug | • BW-20507 with/without NUCs will be administrated for 48 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 1. The proportion of participants who meet the NUC discontinuation criteria at Week 72 in participants with baseline HBsAg ⩽ 3000 IU/mL and HBeAg-negative. | Week 72 |
| Measure | Description | Time Frame |
|---|---|---|
| HBsAg changes throughout the study | up to 124 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Argo Investigative Site | Hefei | Anhui | 230022 | China | ||
| Argo Investigative Site |
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| BW-20507 with/without NUC, Peg-IFNa | Drug | • BW-20507 with/without NUC will be administrated for 48 weeks, Peg-IFNa will be administrated. |
|
| Beijing |
| Beijing Municipality |
| 100015 |
| China |
| Argo Investigative Site | Sichuan | Chengdu | China |
| Argo Investigative Site | Chongqing | Chongqing Municipality | 400000 | China |
| Argo Investigative Site | Chongqing | Chongqing Municipality | China |
| Argo Investigative Site | Fuzhou | Fujian | 350000 | China |
| Argo Investigative Site | Guangzhou | Guangdong | 510515 | China |
| Argo Investigative Site | Shenzhen | Guangdong | 518000 | China |
| Argo Investigative Site | Zunyi | Guizhou | 563000 | China |
| Argo Investigative Site | Changzhou | Jiangsu | 213000 | China |
| Argo Investigative Site | Xuzhou | Jiangsu | 22100 | China |
| Argo Investigative Site | Nanchang | Jiangxi | 330000 | China |
| Argo Investigative Site | Jiangxi | Nanchang | China |
| Argo Investigative Site | Shanghai | Shanghai Municipality | 2000001 | China |
| Argo Investigative Site | Chengdu | Sichaun | 610041 | China |
| Argo Investigative Site | Chengdu | Sichuan | 610041 | China |
| Argo Investigative Site | Zhejiang | Wenzhou | China |
| Argo Investigative Site | Hangzhou | Zhejiang | 310000 | China |
| 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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