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ACTIVE NOT RECRUITING
NCT07246889
PHASE3

Study of AHB-137 in Participants With Chronic Hepatitis B (CHB) Treated With Nucleos(t)Ide Analogues (NAs)(AUSHINE)

Sponsor: Ausper Biopharma Co., Ltd.

View on ClinicalTrials.gov

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

Interventions

DRUG

AHB-137

AHB-137 will be injected weekly by subcutaneous injection. There are 2 leading doses on day 4 and day 11.

DRUG

Placebo

Placebo will be injected weekly by subcutaneous injection.Two additional doses given on day 4 and day 11.

DRUG

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