🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT07246889
Active, not recruiting Phase 3

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

NCT07246889 · tracked via the Priya Life Science China tracker
Sponsor
Ausper Biopharma Co., Ltd.
Phase
Phase 3
Started
2025-08-12
Last updated
2026-05-04

Condition(s) studied

Chronic Hepatitis B

Investigational drug(s) / intervention(s)

AHB-137PlaceboNA therapy

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Participants voluntarily participate in the study, and sign the Informed Consent Form (ICF) prior to screening, able to complete the study according to the protocol; * At least 18 years of age at the time of signing the ICF; * Body mass index met the requirements; * HBeAg negative at screening; * HBsAg or HBV DNA positive for at least 6 months; * Meet relevant requirements for NAs treatment; * 100 IU/mL \< HBsAg ≤ 3000 IU/mL, HBV DNA \< 100 IU/mL and liver function indicators meet the requirements; * Effective contraception as required. Exclusion Criteria: * Clinically significant abnormalities other than a history of chronic HBV infection; * Concomitant clinically significant other liver diseases; * Previous/current manifestations of hepatic decompensation; * Significant hepatic fibrosis or cirrhosis; * Presence of protocol-specified laboratory abnormalities; * History of malignancy or ongoing assessment of possible malignancy; * Those allergic to AHB-137 or its components; * Participants with recent major trauma or major surgery, or planning surgery; * Those who are participating in another clinical trial, or have not undergone a protocol-specified washout period prior to this study; * Prior/current use of prohibited medications; * Inappropriate for participation in this trial as judged by the investigator.

Primary outcome measure(s)

Trial sites (28)

FacilityCityRegionStatus
AusperBio Investigational Site Hefei Anhui
AusperBio Investigational Site Beijing Beijing Municipality
AusperBio Investigational Site Chongqing Chongqing Municipality
AusperBio Investigational Site Fuzhou Fujian
AusperBio Investigational Site Xiamen Fujian
AusperBio Investigational Site Lanzhou Gansu
AusperBio Investigational Site Foshan Guangdong
AusperBio Investigational Site Guangzhou Guangdong
AusperBio Investigational Site Shenzhen Guangdong
AusperBio Investigational Site Liuzhou Guangxi
AusperBio Investigational Site Nanning Guangxi
AusperBio Investigational Site Guiyang Guizhou
AusperBio Investigational Site Zunyi Guizhou
AusperBio Investigational Site Haikou Hainan
AusperBio Investigational Site Zhengzhou Henan
AusperBio Investigational Site Wuhan Hubei
AusperBio Investigational Site Changsha Hunan
AusperBio Investigational Site Nanjing Jiangsu
AusperBio Investigational Site Zhenjiang Jiangsu
AusperBio Investigational Site Nanchang Jiangxi
AusperBio Investigational Site Changchun Jilin
AusperBio Investigational Site Shenyang Liaoning
AusperBio Investigational Site Shanghai Shanghai Municipality
AusperBio Investigational Site Taiyuan Shanxi
AusperBio Investigational Site Xi’an Shanxi
AusperBio Investigational Site Chengdu Sichuan
AusperBio Investigational Site Kunming Yunnan
AusperBio Investigational Site Hangzhou Zhejiang

More Ausper Biopharma Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07246889 on ClinicalTrials.gov ↗ ← All trials in China