Chronic Hepatitis BNCT07146100

Long-term Follow-up Study to Evaluate Participants With Chronic Hepatitis B (CHB) Previously Treated With AHB-137 Injection

An observational study of Chronic Hepatitis B, run by Ausper Biopharma Co., Ltd. at 37 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Trial summary

This study is a prospective, open-label, multicenter long-term follow-up study to evaluate the durability of virologic response in subjects with chronic hepatitis B previously treated with AHB-137 injection. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Hepatitis B
How many people: 200 participants
Where: 37 sitesChina
Study dates: 28 Aug 2025to 1 Jan 2030
Phase: Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Participants who have previously participated in AHB-137 clinical trials

Who may be able to join

Capable of giving informed consent.
Participants who have previously received at least one dose of AHB-137 and achieved the complete of partial response in the parent study without rescue medication and who maintained response until the End of Study (EoS) visit in their parent study.

Who cannot join

Participants who have/or are currently participating in another interventional clinical study since completing their treatment with AHB-137.
Suspected for cancer at screening or any condition required hospitalization during this study , or any condition which, in the opinion of the investigator or Medical Monitor, contraindicates their participation in this study.

Trial locations and contacts

37 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Lu contact

0571-86959519

clinicaltrial@ausperbio.com

City, postcode or hospital

Sites recruiting now only

37 sites in 1 country

China37 sites, 37 recruiting

AusperBio Investigational Site
Beijing, Beijing Municipality
Lu, 057186959519, clinicaltrial@ausperbio.com
Jidong Jia
Not yet recruiting
AusperBio Investigational Site
Changchun, Jilin
Lu, 0571-86959519, clinicaltrial@ausperbio.com
Junqi Niu
Recruiting
AusperBio Investigational Site
Changhou, Jiangsu
Lu, 057186959519, clinicaltrial@ausperbio.com
Guohong Ge
Recruiting
AusperBio Investigational Site
Changsha, Hunan
Lu, 057186959519, clinicaltrial@ausperbio.com
clinicaltrial@ausperbio.com
Not yet recruiting
AusperBio Investigational Site
Changsha, Hunan
Lu, 057186959519, clinicaltrial@ausperbio.com
clinicaltrial@ausperbio.com
Not yet recruiting
AusperBio Investigational Site
Chengdu, Sichuan
Lu, 057186959519, clinicaltrial@ausperbio.com
clinicaltrial@ausperbio.com
Not yet recruiting
AusperBio Investigational Site
Chengdu, Sichuan
Lu, 057186959519, clinicaltrial@ausperbio.com
clinicaltrial@ausperbio.com
Not yet recruiting
AusperBio Investigational Site
Chongqing, Chongqing Municipality
Lu, 057186959519, clinicaltrial@ausperbio.com
Dazhi Zhang
Recruiting
AusperBio Investigational Site
Chongqing, Chongqing Municipality
Lu, 057186959519, clinicaltrial@ausperbio.com
clinicaltrial@ausperbio.com
Not yet recruiting
AusperBio Investigational Site
Foshan, Guangdong
Lu, 057186959519, clinicaltrial@ausperbio.com
clinicaltrial@ausperbio.com
Not yet recruiting
AusperBio Investigational Site
Fuzhou, Fujian
Lu, 057186959519, clinicaltrial@ausperbio.com
Haibing Gao
Recruiting
AusperBio Investigational Site
Guangzhou, Guangdong
Lu, 0571-86959519, clinicaltrial@ausperbio.com
Jinlin Hou
Recruiting
AusperBio Investigational Site
Guangzhou, Guangdong
Lu, 057186959519, clinicaltrial@ausperbio.com
Guan Yujuan
Recruiting
AusperBio Investigational Site
Guangzhou, Guangdong
Lu, 057186959519, clinicaltrial@ausperbio.com
clinicaltrial@ausperbio.com
Not yet recruiting
AusperBio Investigational Site
Guangzhou, Guangdong
Lu, 057186959519, clinicaltrial@ausperbio.com
clinicaltrial@ausperbio.com
Not yet recruiting
AusperBio Investigational Site
Haikou, Hainan
Lu, 057186959519, clinicaltrial@ausperbio.com
clinicaltrial@ausperbio.com
Not yet recruiting
AusperBio Investigational Site
Hangzhou, Zhejiang
Lu, 057186959519, clinicaltrial@ausperbio.com
Yunqing Qiu
Recruiting
AusperBio Investigational Site
Hangzhou, Zhejiang
Lu, 057186959519, clinicaltrial@ausperbio.com
clinicaltrial@ausperbio.com
Not yet recruiting
AusperBio Investigational Site
Hangzhou, Zhejiang
Lu, 057186959519, clinicaltrial@ausperbio.com
clinicaltrial@ausperbio.com
Not yet recruiting
AusperBio Investigational Site
Hefei, Anhui
Lu, 057186959519, clinicaltrial@ausperbio.com
clinicaltrial@ausperbio.com
Not yet recruiting
AusperBio Investigational Site
Kunming, Yunnan
Lu, 057186959519, clinicaltrial@ausperbio.com
Hui Li
Not yet recruiting
AusperBio Investigational Site
Lanzhou, Gansu
Lu, 057186959519, clinicaltrial@ausperbio.com
clinicaltrial@ausperbio.com
Not yet recruiting
AusperBio Investigational Site
Liuzhou, Guangxi
Lu, 057186959519, clinicaltrial@ausperbio.com
clinicaltrial@ausperbio.com
Not yet recruiting
AusperBio Investigational Site
Nanchang, Jiangxi
Lu, 057186959519, clinicaltrial@ausperbio.com
clinicaltrial@ausperbio.com
Not yet recruiting
AusperBio Investigational Site
Nanjing, Jiangsu
Lu, 057186959519, clinicaltrial@ausperbio.com
clinicaltrial@ausperbio.com
Not yet recruiting
AusperBio Investigational Site
Nanning, Guangxi
Lu, 057186959519, clinicaltrial@ausperbio.com
clinicaltrial@ausperbio.com
Not yet recruiting
AusperBio Investigational Site
Shanghai, Shanghai Municipality
Lu, 057186959519, clinicaltrial@ausperbio.com
clinicaltrial@ausperbio.com
Not yet recruiting
AusperBio Investigational Site
Shenyang, Liaoning
Lu, 057186959519, clinicaltrial@ausperbio.com
clinicaltrial@ausperbio.com
Not yet recruiting
AusperBio Investigational Site
Shenzhen, Guangdong
Lu, 057186959519, clinicaltrial@ausperbio.com
clinicaltrial@ausperbio.com
Not yet recruiting
AusperBio Investigational Site
Shenzhen, Guangdong
Lu, 057186959519, clinicaltrial@ausperbio.com
clinicaltrial@ausperbio.com
Not yet recruiting
AusperBio Investigational Site
Taiyuan, Shanxi
Lu, 057186959519, clinicaltrial@ausperbio.com
clinicaltrial@ausperbio.com
Not yet recruiting
AusperBio Investigational Site
Wuhan, Hubei
Lu, 057186959519, clinicaltrial@ausperbio.com
clinicaltrial@ausperbio.com
Not yet recruiting
AusperBio Investigational Site
Xi’an, Shanxi
Lu, 057186959519, clinicaltrial@ausperbio.com
clinicaltrial@ausperbio.com
Not yet recruiting
AusperBio Investigational Site
Xiamen, Fujian
Lu, 057186959519, clinicaltrial@ausperbio.com
clinicaltrial@ausperbio.com
Not yet recruiting
AusperBio Investigational Site
Zhengzhou, Henan
Lu, 057186959519, clinicaltrial@ausperbio.com
clinicaltrial@ausperbio.com
Not yet recruiting
AusperBio Investigational Site
Zhenjiang, Jiangsu
Lu, 057186959519, clinicaltrial@ausperbio.com
Youwen Tan
Recruiting
AusperBio Investigational Site
Zunyi, Guizhou
Lu, 057186959519, clinicaltrial@ausperbio.com
clinicaltrial@ausperbio.com
Not yet recruiting

Other trials in China

About this study

Official title: Prospective, Open-label, Multicenter Long-term Follow-up Study to Evaluate the Durability of Virologic Response in Participants With Chronic Hepatitis B Previously Treated With AHB-137 Injection

Conditions: Chronic Hepatitis B
Keywords: Hepatitis B, Chronic
Medical subject headings: Hepatitis B, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07146100
Study group	Role	What they receive
Participants who have previously participated in AHB-137 clinical trials		Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of participants maintained complete response(defined as HBsAg < 0.05IU/mL and HBV DNA < lower limit of quantification).
Measured: Up to 80 weeks

Secondary outcomes (8)

Proportion of participants achieving and maintaining HBsAg<0.05 IU/mL.
Measured: Up to 80 weeks
Time to loss of HBsAg reversion.
Measured: Up to 80 weeks
Proportion and time of participants meeting certain test indicators after discontinuation of all CHB treatment.
Measured: Up to 80 weeks
Serum levels of HBsAg, HBV DNA, HBV RNA, HBcrAg, HBsAb,HBeAb.
Measured: Up to 80 weeks
Changes of the five-level five-dimensional health scale (EQ-5D-5L) instrument in participants compared with baseline.
Measured: Up to 80 weeks
Percentage of participants with mutations
Measured: Up to 80 weeks
Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAE), adverse events, hepatic endpoint events, deathsand clinically significant examination results.
Examination including laboratory examination, electrocardiogram (ECG) examination.
Measured: Up to 80 weeks
Changes of the hepatitis B quality of life (HBQOL) instrument in participants compared with baseline.
Measured: Up to 80 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Aug 20251 Jan 2030

First posted28 Aug 2025
Study start28 Aug 2025
Primary completion1 Jan 2028 (estimated)
Study completion1 Jan 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 200 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07146100
Sponsor's protocol ID: AB-10-8004
Status last verified: Aug 2026
First submitted: 19 Aug 2025
Last updated: 18 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

0571-86959519

clinicaltrial@ausperbio.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
RecruitingPhase 2
A Study to Evaluate the Efficacy and Safety of Combination Therapy of BRII-179, BRII-835 and PEG-IFNα in Participants With Chronic Hepatitis B Virus (HBV) Infection (ENHANCE)
Chronic Hepatitis B Virus (HBV) Infection
Not yet recruitingPhase 1
A Clinical Study of AHB-121 in Healthy Participants and Chronic Hepatitis B (CHB) Participants
Chronic Hepatitis B Virus
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection

All Chronic Hepatitis B trials