Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is a randomized, double-blind, multicenter phase 3 clinical trial to evaluate the efficacy and safety of AHB-137 injection in participants with HBeAg-negative CHB treated with NAs.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AHB-137 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AHB-137 | Drug | AHB-137 will be injected weekly by subcutaneous injection. There are 2 leading doses on day 4 and day 11. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with persistent HBsAg < limit of detection (LOD) and HBV DNA < lower limit of quantification (LLOQ) at the 24th week after all treatment for CHB was discontinued | 24 weeks after discontinuation of all CHB treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with persistent HBV DNA < LLOQ . | 24 weeks after discontinuation of all CHB treatment | |
| Proportion of participants with persistent HBsAg < LOD and HBV DNA < LLOQ | Up to 60 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| AusperBio Clinical Trials | AusperBio Investigational Site | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AusperBio Investigational Site | Hefei | Anhui | China | |||
| AusperBio Investigational Site |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo will be injected weekly by subcutaneous injection.Two additional doses given on day 4 and day 11. |
|
| NA therapy | Drug | NA will be the background therapy. After stopping the AHB-137 or placebo injection, continue for another 12 weeks. |
|
| Concentration of HBsAg, HBV DNA, HBV RNA, HBcrAg, HBsAb,HBeAg, HBeAb | Up to 60 weeks |
| Relapse rate after discontinuation of NAs therapy. | Up to 60 weeks |
| Safety: Number and percentage of participants with detectable anti-drug antibodies (ADA). | Up to 60 weeks |
| Safety: Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAE) and clinically significant examination results. | Up to 60 weeks |
| Plasma concentrations of AHB-137. | Up to 60 weeks |
| Sequencing of the Viral DNA and/or viral RNA analysis for detection of drug resistance in the target region of AHB-137 | Up to 60 weeks |
| Change from baseline in EuroQol Five-Dimension Five-Level Scale (EQ-5D-5L) scores in participants with HBV infection. | The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. | Up to 60 weeks |
| Changes of the hepatitis B quality of life (HBQOL) instrument in participants compared with baseline. | This scale has 31 items, including 7 dimensions: psychological status, expected anxiety, vitality, shame, infectivity, health vulnerability, and viral response. Each item is scored on a 5-point scale, with higher scores indicating a more severe impact of hepatitis B on quality of life. | Up to 60 weeks |
| Beijing |
| Beijing Municipality |
| China |
| AusperBio Investigational Site | Chongqing | Chongqing Municipality | China |
| AusperBio Investigational Site | Fuzhou | Fujian | China |
| AusperBio Investigational Site | Xiamen | Fujian | China |
| AusperBio Investigational Site | Lanzhou | Gansu | China |
| AusperBio Investigational Site | Foshan | Guangdong | China |
| AusperBio Investigational Site | Guangzhou | Guangdong | China |
| AusperBio Investigational Site | Shenzhen | Guangdong | China |
| AusperBio Investigational Site | Liuzhou | Guangxi | China |
| AusperBio Investigational Site | Nanning | Guangxi | China |
| AusperBio Investigational Site | Guiyang | Guizhou | China |
| AusperBio Investigational Site | Zunyi | Guizhou | China |
| AusperBio Investigational Site | Haikou | Hainan | China |
| AusperBio Investigational Site | Zhengzhou | Henan | China |
| AusperBio Investigational Site | Wuhan | Hubei | China |
| AusperBio Investigational Site | Changsha | Hunan | China |
| AusperBio Investigational Site | Nanjing | Jiangsu | China |
| AusperBio Investigational Site | Zhenjiang | Jiangsu | China |
| AusperBio Investigational Site | Nanchang | Jiangxi | China |
| AusperBio Investigational Site | Changchun | Jilin | China |
| AusperBio Investigational Site | Shenyang | Liaoning | China |
| AusperBio Investigational Site | Shanghai | Shanghai Municipality | China |
| AusperBio Investigational Site | Taiyuan | Shanxi | China |
| AusperBio Investigational Site | Xi’an | Shanxi | China |
| AusperBio Investigational Site | Chengdu | Sichuan | China |
| AusperBio Investigational Site | Kunming | Yunnan | China |
| AusperBio Investigational Site | Hangzhou | Zhejiang | 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 |
Not provided
Not provided