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.
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
- Are there results?
- Not yet: the study is under way
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.
37 sites in 1 country
China37 sites, 37 recruiting
- Not yet recruiting
AusperBio Investigational Site
Beijing, Beijing Municipality
Lu, 057186959519, clinicaltrial@ausperbio.com
Jidong Jia
- 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
- Not yet 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
- Recruiting
AusperBio Investigational Site
Chongqing, Chongqing Municipality
Lu, 057186959519, clinicaltrial@ausperbio.com
Dazhi Zhang
- Not yet 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
- 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
- Not yet 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
- Recruiting
AusperBio Investigational Site
Hangzhou, Zhejiang
Lu, 057186959519, clinicaltrial@ausperbio.com
Yunqing Qiu
- Not yet 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
- Recruiting
AusperBio Investigational Site
Zhenjiang, Jiangsu
Lu, 057186959519, clinicaltrial@ausperbio.com
Youwen Tan
- Not yet recruiting
AusperBio Investigational Site
Zunyi, Guizhou
Lu, 057186959519, clinicaltrial@ausperbio.com
clinicaltrial@ausperbio.com
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
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.
- 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 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.
- 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.
- More trials run by Ausper Biopharma Co., Ltd.The sponsor's other registered studies.
- 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)
Sponsor and investigators
- Lead sponsor
- Ausper Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jinlin Hou, Principal investigator, Nanfang Hospital, Southern Medical UniversityJunqi Niu, Principal investigator, The First Hospital of Jilin University
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07146100
- Acronym / sponsor ID
- AB-10-8004
- Conditions
- Chronic Hepatitis B
- Keywords
- Hepatitis B, Chronic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ausper Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Aug 2025 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants who have previously participated in AHB-137 clinical trials | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who have previously participated in AHB-137 clinical trials
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of participants maintained complete response(defined as HBsAg < 0.05IU/mL and HBV DNA < lower limit of quantification).
Time frame: Up to 80 weeks
8 secondary outcomes
Proportion of participants achieving and maintaining HBsAg<0.05 IU/mL.
Time frame: Up to 80 weeks
Time to loss of HBsAg reversion.
Time frame: Up to 80 weeks
Proportion and time of participants meeting certain test indicators after discontinuation of all CHB treatment.
Time frame: Up to 80 weeks
Serum levels of HBsAg, HBV DNA, HBV RNA, HBcrAg, HBsAb,HBeAb.
Time frame: Up to 80 weeks
Changes of the five-level five-dimensional health scale (EQ-5D-5L) instrument in participants compared with baseline.
Time frame: Up to 80 weeks
Percentage of participants with mutations
Time frame: 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.
Time frame: Up to 80 weeks
Changes of the hepatitis B quality of life (HBQOL) instrument in participants compared with baseline.
Time frame: Up to 80 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Chronic Hepatitis B
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A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
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Evaluation of Patients With Liver Disease
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Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
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Chronic Hepatitis B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jinlin Hou principal investigator
Nanfang Hospital, Southern Medical University
Junqi Niu principal investigator
The First Hospital of Jilin University
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis B, run by Ausper Biopharma Co., Ltd. at 37 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lu (0571-86959519, clinicaltrial@ausperbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants maintained complete response(defined as HBsAg < 0.05IU/mL and HBV DNA < lower limit of quantification). (time frame: Up to 80 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.