Study of AHB-137 in Participants With Chronic Hepatitis B (CHB) Treated With Nucleos(t)Ide Analogues (NAs)(AUSHINE)
NCT ID: NCT07246889
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE3
577 participants
INTERVENTIONAL
2025-08-12
2027-09-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
AHB-137
AHB-137
AHB-137 will be injected weekly by subcutaneous injection. There are 2 leading doses 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.
Placebo
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ausper Biopharma Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
AusperBio Clinical Trials
Role: STUDY_DIRECTOR
AusperBio Investigational Site
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AB-10-8006
Identifier Type: -
Identifier Source: org_study_id