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Study of AHB-137 in Participants With Chronic Hepatitis B (CHB) Treated With Nucleos(t)Ide Analogues (NAs)(AUSHINE)
Sponsor: Ausper Biopharma Co., Ltd.
Summary
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.
Official title: A Randomized, Double-blind, Multicenter Phase III Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Participants With HBeAg-negative Chronic Hepatitis B Treated With Nucleos(t)Ide Analogues
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
577
Start Date
2025-08-12
Completion Date
2027-09-01
Last Updated
2025-12-23
Healthy Volunteers
No
Conditions
Interventions
AHB-137
AHB-137 will be injected weekly by subcutaneous injection. There are 2 leading doses on day 4 and day 11.
Placebo
Placebo will be injected weekly by subcutaneous injection.Two additional doses given on day 4 and day 11.
NA therapy
NA will be the background therapy. After stopping the AHB-137 or placebo injection, continue for another 12 weeks.
Locations (28)
AusperBio Investigational Site
Hefei, Anhui, China
AusperBio Investigational Site
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
Liuchow, 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