Chronic Hepatitis BPhase 2NCT07635186
A Study to Evaluate AHB-137 Injection in Treatment-naïve Participants With Chronic Hepatitis B
A Phase 2 study testing AHB-137 in people with Chronic Hepatitis B, run by Ausper Biopharma Co., Ltd. at 34 sites in China.
Trial summary
This study is a randomized, double-blind, placebo-controlled, multicenter phase 2 study to assess the efficacy and safety of AHB-137 injection in treatment-naïve participants with chronic hepatitis B. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- AHB-137
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 34 sitesChina
- Study dates
- 5 Jun 2026to 20 Jun 2028
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteer to participate and sign the informed consent form, and are willing to complete the study in accordance with the requirements of the protocol.
- Aged 18-65 years (including boundary values).
- Body mass index between the range of 18-32 kg/m2 (inclusive boundary values).
- HBsAg or HBV DNA positive for ≥ 6 months at screening and no antiviral treatment with interferon or nucleoside analogue.
- HBsAg and HBV DNA values met protocol requirements at screening.
- ALT < 3xULN at screening.
- Use highly effective contraception as required.
Who cannot join
- Uncontrolled and stable clinically significant abnormalities other than a history of chronic HBV infection.
- Participants with other clinically significant liver diseases, previous/current manifestations of hepatic decompensation, and a history of extrahepatic diseases that may be related to HBV immune status.
- Any serious infection other than chronic hepatitis B infection requiring intravenous anti-infective therapy within 1 month prior to randomization.
- Hepatitis C virus (HCV) infection or < 12 months from cure at screening (HCV RNA positive within 12 months), human immunodeficiency virus (HIV) positive at screening, and syphilis positive (treponema pallidum antibody positive).
- Significant fibrosis or cirrhosis, or liver stiffness value (LSM) > 9.0 kPa at screening.
- Participants with confirmed or suspected liver cancer who have a history of malignancy within the past 5 years or are undergoing assessment for a possible malignancy.
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- Laboratory test results do not meet the criteria.
- Prior/current autoimmune disease, history of vasculitis, or presence of signs, symptoms, or laboratory tests of underlying vasculitis.
- Fridericia ' s formula corrected QT interval (QTcF) ≥ 450 msec for male participants and ≥ 470 msec for female participants at screening.
- Allergic to AHB-137 ingredients, or history of drug allergy or other allergies.
- Major trauma or major surgery within 3 months prior to screening, or planned surgery during the trial.
- Participants are participating in another clinical trial or failing to wash out as required.
- Current use or use of any immunosuppressive medication (e.g. prednisone) within 3 months prior to screening, except for short courses (≤ 2 weeks) or use of topical/inhaled steroids;Those who have used immunomodulators within 3 months prior to screening;Those who have used cytotoxic drugs within 6 months prior to screening;History of vaccination within 1 month prior to screening or a live vaccination plan during the trial.
- Participants that require regular long-term anticoagulants.
- Abnormal thyroid function.
- Participants that have received any antisense oligonucleic acid, siRNA, capsid assembly modulator (CAM) antiviral drug used to treat chronic hepatitis B.
- Any other circumstances or conditions in which, in the opinion of the investigator, the participant is inappropriate for participation in this trial.
Trial locations and contacts
34 sites in 1 country. Contact the study team or a site near you to ask about taking part.
34 sites in 1 country
China34 sites, 34 recruiting
- Recruiting
AusperBio Investigational Site
Beijing, Beijing Municipality
Lu, 057186959519, clinicaltrial@ausperbio.com
Yao Xie
- Recruiting
AusperBio Investigational Site
Changchun, Jilin
Lu, 057186959519, clinicaltrial@ausperbio.com
Yanhang Gao
- Recruiting
AusperBio Investigational Site
Changsha, Hunan
Lu, 057186959519, clinicaltrial@ausperbio.com
Yan Huang
- Recruiting
AusperBio Investigational Site
Changsha, Hunan
Lu, 057186959519, clinicaltrial@ausperbio.com
Yongfang Jiang
- Recruiting
AusperBio Investigational Site
Changsha, Hunan
Lu, 057186959519, clinicaltrial@ausperbio.com
Jing Ma
- Recruiting
AusperBio Investigational Site
Chengdu, Sichuan
Lu, 057186959519, clinicaltrial@ausperbio.com
Hong Tang
- Recruiting
AusperBio Investigational Site
Chengdu, Sichuan
Lu, 057186959519, clinicaltrial@ausperbio.com
Jianmei Lin
- Recruiting
AusperBio Investigational Site
Chengdu, Sichuan
Lu, 057186959519, clinicaltrial@ausperbio.com
Li Zhu
- Recruiting
AusperBio Investigational Site
Chongqing, Chongqing Municipality
Lu, 057186959519, clinicaltrial@ausperbio.com
Guicheng Wu
- Recruiting
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
Lu, 057186959519, clinicaltrial@ausperbio.com
Peng Hu
- Recruiting
AusperBio Investigational Site
Guangzhou, Guangdong
Lu, 057186959519, clinicaltrial@ausperbio.com
Bingliang Lin
- Recruiting
AusperBio Investigational Site
Guangzhou, Guangdong
Lu, 057186959519, clinicaltrial@ausperbio.com
Yujuan Guan
- Recruiting
AusperBio Investigational Site
Guangzhou, Guangdong
Lu, 057186959519, clinicaltrial@ausperbio.com
Xingfei Pan
- Recruiting
AusperBio Investigational Site
Hangzhou, Zhejiang
Lu, 057186959519, clinicaltrial@ausperbio.com
Guoping Sheng
- Recruiting
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
Lu, 057186959519, clinicaltrial@ausperbio.com
Yunqing Qiu
- Recruiting
AusperBio Investigational Site
Jiangmen, Guangdong
Lu, 057186959519, clinicaltrial@ausperbio.com
Gang He
- Recruiting
AusperBio Investigational Site
Kunming, Yunan
Lu, 057186959519, clinicaltrial@ausperbio.com
Hui Li
- Recruiting
AusperBio Investigational Site
Liuzhou, Guangxi
Lu, 057186959519, clinicaltrial@ausperbio.com
Jiaguang Hu
- Recruiting
AusperBio Investigational Site
Meizhou, Guangdong
Lu, 057186959519, clinicaltrial@ausperbio.com
Tianhuang Liu
- Recruiting
AusperBio Investigational Site
Nanchang, Jiangxi
Lu, 057186959519, clinicaltrial@ausperbio.com
Xiaoping Wu
- Recruiting
AusperBio Investigational Site
Nanjing, Jiangsu
Lu, 057186959519, clinicaltrial@ausperbio.com
Jie Li
- Recruiting
AusperBio Investigational Site
Qingyuan, Guangdong
Lu, 057186959519, clinicaltrial@ausperbio.com
Xi He
- Recruiting
AusperBio Investigational Site
Shanghai, Shanghai Municipality
Lu, 057186959519, clinicaltrial@ausperbio.com
Qing Xie
- Recruiting
AusperBio Investigational Site
Shanghai, Shanghai Municipality
Lu, 057186959519, clinicaltrial@ausperbio.com
Jiming Zhang
- Recruiting
AusperBio Investigational Site
Shanghai, Shanghai Municipality
Lu, 057186959519, clinicaltrial@ausperbio.com
Liang Chen
- Recruiting
AusperBio Investigational Site
Shenyang, Liaoning
Lu, 057186959519, clinicaltrial@ausperbio.com
Yang Ding
- Recruiting
AusperBio Investigational Site
Shenzhen, Guangdong
Lu, 057186959519, clinicaltrial@ausperbio.com
Hongzhou Lu
- Recruiting
AusperBio Investigational Site
Shenzhen, Guangdong
Lu, 057186959519, clinicaltrial@ausperbio.com
Guoxin Hu
- Recruiting
AusperBio Investigational Site
Wuhan, Hubei
Lu, 057186959519, clinicaltrial@ausperbio.com
Xin Zheng
- Recruiting
AusperBio Investigational Site
Wuhan, Hubei
Lu, 057186959519, clinicaltrial@ausperbio.com
Kai Dai
- Recruiting
AusperBio Investigational Site
Xi’an, Shanxi
Lu, 057186959519, clinicaltrial@ausperbio.com
Yingli He
- Recruiting
AusperBio Investigational Site
Xi’an, Shanxi
Lu, 057186959519, clinicaltrial@ausperbio.com
Shuangsuo Dang
- Recruiting
AusperBio Investigational Site
Xiamen, Fujian
Lu, 057186959519, clinicaltrial@ausperbio.com
Qianguo Mao
- Recruiting
AusperBio Investigational Site
Yichang, Hubei
Lu, 057186959519, clinicaltrial@ausperbio.com
Xiaolin Zhou
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 2 Clinical Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Treatment-naïve Participants With Chronic Hepatitis B.
This study is a randomized, double-blind, placebo-controlled, multicenter phase 2 study to assess the efficacy and safety of AHB-137 injection in treatment-naïve participants with chronic hepatitis B.
- Conditions
- Chronic Hepatitis B
- Being tested
- AHB-137, Placebo
- Keywords
- Chronic Hepatitis B
- 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.
AHB-137Drug
AHB-137 will be administered subcutaneously.
PlaceboDrug
Placebo will be administered subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| AHB-137 | Experimental | AHB-137 will be administered subcutaneously. Receives: Drug: AHB-137 |
| Placebo | Placebo comparator | Placebo will be administered subcutaneously. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
HBV DNA < lower limit of quantitation (LLOQ), 10 IU/mL, HBsAg < limit of detection (LOD), 0.05 IU/mL with or without hepatitis B virus surface antibody (HBsAb) 24 weeks after discontinuation of all chronic hepatitis B treatment.
Measured: Up to 48 weeks.
Highly sensitive HBsAg < 0.005 IU/mL and HBV DNA < LLOQ (10 IU/mL) at the end of treatment.
Measured: Up to 48 weeks.
Secondary outcomes (20)
HBV DNA < LLOQ, 10 IU/mL, and HBsAg < 10 IU/mL 24 weeks after discontinuation of all chronic hepatitis B treatment.
Measured: Up to 48 weeks.
HBV DNA < LLOQ 24 weeks after discontinuation of all chronic hepatitis B treatment.
Measured: Up to 48 weeks.
HBV DNA < LLOQ and HBsAg < 100 IU/mL 24 weeks after discontinuation of all chronic hepatitis B treatment.
Measured: Up to 48 weeks.
HBsAg seroconversion rate 24 weeks after discontinuation of all chronic hepatitis B treatment.
HBsAg seroconversion : serum HBsAg<LOD, and at the same time or subsequently, HBsAb>10 IU/L.
Measured: Up to 48 weeks.
HBeAg seroconversion rate 24 weeks after discontinuation of all chronic hepatitis B treatment.
HBeAg seroconversion:HBeAg negative, with simultaneous or subsequent positivity for HBeAb.
Measured: Up to 48 weeks.
Proportion of participants who discontinued all chronic hepatitis B treatment at the end of treatment.
Measured: Up to 48 weeks.
HBV DNA < LLOQ and HBsAg < LOD rate and HBV DNA < LLOQ and HBsAg < 10 IU/mL rate by visit.
Measured: Up to 48 weeks.
HBsAg, HBeAg seroconversion rates by visit.
HBsAg seroconversion: serum HBsAg<LOD, and at the same time or subsequently, HBsAb>10 IU/L.
HBeAg seroconversion: HBeAg negative, with simultaneous or subsequent positivity for HBeAb.
Measured: Up to 48 weeks.
Test Values of Virological Parameters.
HBsAb, HBsAg, HBV DNA values and changes from baseline at each visit.
Measured: Up to 48 weeks.
Time to first achievement of HBsAg and first HBeAg seroconversion.
HBsAg seroconversion: serum HBsAg<LOD, and at the same time or subsequently, HBsAb>10 IU/L.
HBeAg seroconversion: HBeAg negative, with simultaneous or subsequent positivity for HBeAb.
Measured: Up to 48 weeks.
Changes of the hepatitis B quality of life (HBQOL) instrument in participants compared with baseline.
Response options range from 1 to 5 with higher scores indicating more severe impact .
Measured: Up to 48 weeks.
Changes of the score of EuroQol Five-Dimension Five-Level Scale (EQ-5D-5L) in participants compared with baseline.
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the participant's health state.
Measured: Up to 48 weeks.
Proportion of participants with protocol-defined virologic response for HBsAg and HBV DNA.
Measured: Up to 48 weeks.
Change from baseline in alanine aminotransferase (ALT) and noninvasive assessment of liver fibrosis at each visit.
Measured: Up to 48 weeks.
Time to normalization of ALT without rescue therapy (for participants with abnormal baseline ALT).
Measured: Up to 48 weeks.
AHB-137 resistance analysis.
Method: Sequencing of HBV DNA/RNA.
Measured: Up to 48 weeks.
Proportion of participants who are HBeAb positive and HBeAg negative, and the test values of HBsAb, HBsAg and HBV DNA meet certain conditions.
Measured: Up to 48 weeks.
Safety: number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAE) and clinically significant examination results.
Examination including laboratory examination, electrocardiogram (ECG) examination.
Measured: Up to 48 weeks.
Proportion of participants with positive anti-drug antibody (ADA) and ADA level at each visit.
Measured: Up to 48 weeks.
Plasma drug concentration of AHB-137.
Measured: Up to 48 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start5 Jun 2026
- Primary completion20 Jun 2027 (estimated)
- Study completion20 Jun 2028 (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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ausper Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yunqing Qiu, Principal investigator, First Affiliated Hospital of Zhejiang UniversityPeng Hu, Principal investigator, The Second Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07635186
- Sponsor's protocol ID
- AB-10-8016
- Status last verified
- Jul 2026
- First submitted
- 28 May 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 2 Clinical Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Treatment-naïve Participants With Chronic Hepatitis B.
- ClinicalTrials.gov ID
- NCT07635186
- Acronym / sponsor ID
- AB-10-8016
- Conditions
- Chronic Hepatitis B
- Keywords
- Chronic Hepatitis B
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Ausper Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Jun 2026 (actual)
- Primary completion
- 20 Jun 2027 (estimated)
- Study completion
- 20 Jun 2028 (estimated)
- First posted
- 9 Jun 2026 (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 randomized, double-blind, placebo-controlled, multicenter phase 2 study to assess the efficacy and safety of AHB-137 injection in treatment-naïve participants with chronic hepatitis B.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AHB-137 | Experimental | Drug: AHB-137AHB-137 will be administered subcutaneously. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo will be administered subcutaneously. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Volunteer to participate and sign the informed consent form, and are willing to complete the study in accordance with the requirements of the protocol.
- Aged 18-65 years (including boundary values).
- Body mass index between the range of 18-32 kg/m2 (inclusive boundary values).
- HBsAg or HBV DNA positive for ≥ 6 months at screening and no antiviral treatment with interferon or nucleoside analogue.
- HBsAg and HBV DNA values met protocol requirements at screening.
Key exclusion criteria (17 listed)
- Uncontrolled and stable clinically significant abnormalities other than a history of chronic HBV infection.
- Participants with other clinically significant liver diseases, previous/current manifestations of hepatic decompensation, and a history of extrahepatic diseases that may be related to HBV immune status.
- Any serious infection other than chronic hepatitis B infection requiring intravenous anti-infective therapy within 1 month prior to randomization.
- Hepatitis C virus (HCV) infection or < 12 months from cure at screening (HCV RNA positive within 12 months), human immunodeficiency virus (HIV) positive at screening, and syphilis positive (treponema pallidum antibody positive).
- Significant fibrosis or cirrhosis, or liver stiffness value (LSM) > 9.0 kPa at screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AHB-137AHB-137 will be administered subcutaneously. | Drug | AHB-137 |
| PlaceboPlacebo will be administered subcutaneously. | Drug | Placebo |
Primary outcome
HBV DNA < lower limit of quantitation (LLOQ), 10 IU/mL, HBsAg < limit of detection (LOD), 0.05 IU/mL with or without hepatitis B virus surface antibody (HBsAb) 24 weeks after discontinuation of all chronic hepatitis B treatment.
Time frame: Up to 48 weeks.
Highly sensitive HBsAg < 0.005 IU/mL and HBV DNA < LLOQ (10 IU/mL) at the end of treatment.
Time frame: Up to 48 weeks.
20 secondary outcomes
HBV DNA < LLOQ, 10 IU/mL, and HBsAg < 10 IU/mL 24 weeks after discontinuation of all chronic hepatitis B treatment.
Time frame: Up to 48 weeks.
HBV DNA < LLOQ 24 weeks after discontinuation of all chronic hepatitis B treatment.
Time frame: Up to 48 weeks.
HBV DNA < LLOQ and HBsAg < 100 IU/mL 24 weeks after discontinuation of all chronic hepatitis B treatment.
Time frame: Up to 48 weeks.
HBsAg seroconversion rate 24 weeks after discontinuation of all chronic hepatitis B treatment.
Time frame: Up to 48 weeks.
HBeAg seroconversion rate 24 weeks after discontinuation of all chronic hepatitis B treatment.
Time frame: Up to 48 weeks.
Proportion of participants who discontinued all chronic hepatitis B treatment at the end of treatment.
Time frame: Up to 48 weeks.
HBV DNA < LLOQ and HBsAg < LOD rate and HBV DNA < LLOQ and HBsAg < 10 IU/mL rate by visit.
Time frame: Up to 48 weeks.
HBsAg, HBeAg seroconversion rates by visit.
Time frame: Up to 48 weeks.
Test Values of Virological Parameters.
Time frame: Up to 48 weeks.
Time to first achievement of HBsAg and first HBeAg seroconversion.
Time frame: Up to 48 weeks.
Changes of the hepatitis B quality of life (HBQOL) instrument in participants compared with baseline.
Time frame: Up to 48 weeks.
Changes of the score of EuroQol Five-Dimension Five-Level Scale (EQ-5D-5L) in participants compared with baseline.
Time frame: Up to 48 weeks.
Proportion of participants with protocol-defined virologic response for HBsAg and HBV DNA.
Time frame: Up to 48 weeks.
Change from baseline in alanine aminotransferase (ALT) and noninvasive assessment of liver fibrosis at each visit.
Time frame: Up to 48 weeks.
Time to normalization of ALT without rescue therapy (for participants with abnormal baseline ALT).
Time frame: Up to 48 weeks.
AHB-137 resistance analysis.
Time frame: Up to 48 weeks.
Proportion of participants who are HBeAb positive and HBeAg negative, and the test values of HBsAb, HBsAg and HBV DNA meet certain conditions.
Time frame: Up to 48 weeks.
Safety: number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAE) and clinically significant examination results.
Time frame: Up to 48 weeks.
Proportion of participants with positive anti-drug antibody (ADA) and ADA level at each visit.
Time frame: Up to 48 weeks.
Plasma drug concentration of AHB-137.
Time frame: Up to 48 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 29 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Yunqing Qiu principal investigator
First Affiliated Hospital of Zhejiang University
Peng Hu principal investigator
The Second Affiliated Hospital of Chongqing Medical University
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AHB-137 in people with Chronic Hepatitis B, run by Ausper Biopharma Co., Ltd. at 34 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 7 inclusion and 17 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 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
HBV DNA < lower limit of quantitation (LLOQ), 10 IU/mL, HBsAg < limit of detection (LOD), 0.05 IU/mL with or without hepatitis B virus surface antibody (HBsAb) 24 weeks after discontinuation of all chronic hepatitis B treatment. (time frame: Up to 48 weeks.). The study lists 2 primary outcomes in all. 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 29 Jul 2026.