Chronic Hepatitis BPhase 2NCT07069569
A Multicenter Study of AHB-137 Injection Combined With Other Hepatitis B Drugs
A Phase 2 study testing AHB-137, Peg-IFN and Hepatitis B Vaccine in people with Chronic Hepatitis B, run by Ausper Biopharma Co., Ltd. at 14 sites in China.
Trial summary
This is a randomized, open-label, multicenter phase II study to evaluate the efficacy and safety of AHB-137 injection in combination with other hepatitis B drugs in participants with HBeAg-negative CHB treated with NAs. 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, Peg-IFN and Hepatitis B Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 14 sitesChina
- Study dates
- 8 Jun 2025to 15 Jan 2028
- Phase
- Phase 2
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
- 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;
- Aged between 18 and 65 years at the time of signing the ICF;
- Body mass index (BMI) within the range of 18-30 kg/ m2;
- HBeAg negative at screening;
- HBsAg or HBV DNA positive for at least 6 months;
- Continue antiviral therapy with a single nucleoside (t) ide analogue for more than 6 months prior to screening;
- Alanine aminotransferase (ALT) ≤ 2 × upper limit of normal (ULN);
- Effective contraception as required.
Who cannot join
- Participants who are not eligible for treatment with Peg-IFN/recombinant hepatitis B vaccine;
- Clinically significant abnormalities other than a history of chronic HBV infection;
- Concomitant clinically significant other liver diseases;
- Any serious infection other than chronic hepatitis B infection requiring intravenous anti-infective therapy within 1 month prior to screening;
- HCV RNA positive, Human immunodeficiency virus (HIV) positive, syphilis positive;
- Significant liver fibrosis or cirrhosis at screening, or a liver stiffness value (LSM) > 9.0 kPa;
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- Previous/current manifestations of hepatic decompensation;
- Diagnosis or suspicion of hepatocellular carcinoma, or alpha-fetoprotein concentration (AFP) ≥ 20 ng/mL at screening;
- Obviously abnormal laboratory test results;
- History of vasculitis or presence of signs, symptoms, or laboratory tests of underlying vasculitis, and previous/current other diseases that may be related to vasculitic conditions;
- QT interval corrected for heart rate (Fridericia method) abnormal;
- History of extrahepatic disease possibly related to HBV immune status;
- Participants with a history of malignancy within the past 5 years or who are being evaluated for a possible malignancy;
- Serious mental illness or history of serious mental illness prior to screening;
- Suspected history of allergy to any component of the study drug, or allergic constitution;
- Major trauma or major surgery within 3 months prior to screening, or planned surgery during the study;
- Those who are participating in another clinical trial, or have not undergone a protocol-specified washout period prior to this study;
- Current use or use of any immunosuppressive medication within 3 months prior to screening, with the exception of short courses (≤ 2 weeks) or use of topical/inhaled steroids;Those who have used immunomodulators and cytotoxic drugs within 6 months prior to the first dose;Or a history of vaccination within 6 months prior to screening or a live vaccination plan during the trial;
- Participants requiring regular long-term administration of anticoagulants or antiplatelet drugs;
- Thyroid dysfunction;
- Patients with uncontrolled epilepsy and other progressive neurological disorders;
- Received any antisense oligonucleotides (ASO) or small molecule interfering ribonucleic acid (siRNA) drug;
- Any other circumstance or condition that, in the opinion of the investigator, the participants are inappropriate for participation in the study.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
China14 sites, 14 recruiting
- Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality
Zuo, 010-63139003, yyyyecp1@163.com
- Recruiting
AusperBio Investigational Site
Changchun, Jilin
Lu, 057186959519, clinicaltrial@ausperbio.com
Yanhang Gao
- 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
Peng Hu
- Recruiting
AusperBio Investigational Site
Fuzhou, Fujian
Lu, 057186959519, clinicaltrial@ausperbio.com
Haibing Gao
- 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
Hangzhou, Zhejiang
Lu, 057186959519, clinicaltrial@ausperbio.com
Fangfang Lv
- Recruiting
AusperBio Investigational Site
Kunming, Yunnan
Lu, 057186959519, clinicaltrial@ausperbio.com
Jia Wei
- 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
Zunyi, Guizhou
Lu, 057186959519, clinicaltrial@ausperbio.com
Yawen Luo
About this study
Official title: A Randomized, Open-Label, Multicenter Phase II Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Combination With Hepatitis B Vaccine or Pegylated Interferon α-2b (Peg-IFN) in Participants With HBeAg-Negative Chronic Hepatitis B (CHB) Treated With Nucleos(t)Ide Analogue (NAs)
This is a randomized, open-label, multicenter phase II study to evaluate the efficacy and safety of AHB-137 injection in combination with other hepatitis B drugs in participants with HBeAg-negative CHB treated with NAs.
- Conditions
- Chronic Hepatitis B
- Being tested
- AHB-137, Peg-IFN, Hepatitis B Vaccine
- 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.
AHB-137Drug
AHB-137 will be injected.
Peg-IFNDrug
Peg-IFN will be administered .
Hepatitis B VaccineDrug
Hepatitis B vaccine will be administered.
| Study group | Role | What they receive |
|---|---|---|
| AHB-137 (16 weeks) and Peg-IFN | Experimental | Not described Receives: Drug: AHB-137; Drug: Peg-IFN |
| AHB-137 (24 weeks) and Peg-IFN | Experimental | Not described Receives: Drug: AHB-137; Drug: Peg-IFN |
| AHB-137 and Hepatitis B vaccine | Experimental | Not described Receives: Drug: AHB-137; Drug: Hepatitis B Vaccine |
| AHB-137 | Experimental | Not described Receives: Drug: AHB-137 |
| AHB-137 (24 weeks) and Peg-IFN(24 weeks) | Experimental | R3 group Receives: Drug: AHB-137; Drug: Peg-IFN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with persistent HBsAg < limit of detection (LOD) and HBV DNA < lower limit of quantification (LLOQ) at the 24th week after all treatment for CHB was discontinued.
Measured: up to 72 weeks
Secondary outcomes (15)
Proportion of participants with persistent HBsAg < LOD and HBV DNA < LLOQ .
Measured: Up to 72 weeks
Detection of the serum concentration of HBsAg, HBsAb, HBV DNA, HBV RNA, HBcrAg, HBeAb,and HBeAg.
Measured: Up to 72 weeks
Proportion of participants who met discontinuation criteria for NAs treatment at the end of the treatment period.
Measured: Up to 48 weeks
Relapse rate after discontinuation of NAs therapy.
Measured: Up to 72 weeks
Change from baseline in alanine aminotransferase (ALT) values and time to normalization of values.
Measured: Up to 72 weeks
Relapse time after discontinuation of NAs therapy.
Measured: Up to 72 weeks
Plasma concentrations of AHB-137.
Measured: Up to 48 weeks
Serum concentrations of Peg-IFN.
Measured: Up to 48 weeks.
Safety: Number and percentage of participants with detectable anti-drug antibodies (ADA).
Measured: Up to 72 weeks
Safety: Changes of the hepatitis B quality of life (HBQOL) instrument in participants compared with baseline.
This scale has 31 items, including 7 dimensions: psychological status, expected anxiety, vitality, shame, infectivity, health vulnerability, and viral response. Each item is scored on a 5-point scale, with higher scores indicating a more severe impact of hepatitis B on quality of life.
Measured: Up to 72 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 72 weeks
Safety: Monitoring the score changes of Columbia Suicide Severity Scale (CSSRS) .
The CSSRS is a categorical, interviewer-rated instrument that screens for suicidal ideation (five items, 0-1 each) and suicidal behavior (six items, 0-1 each); the highest positive item defines the risk level rather than a total score. For ideation items 3-5 an additional 0-5 intensity rating can be recorded. Across all items the minimum value is 0 (absent) and the maximum is 1 (present); a score of 1 on any item indicates a worse outcome and triggers escalating clinical safeguards, with any behavior item being tantamount to a suicidal event.
Measured: Up to 72 weeks.
Safety: 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 patient's health state.
Measured: Up to 72 weeks
Safety: Monitoring the score changes of Self-Rating Depression Scale (SDS).
The SDS is a 20-item, 4-point Likert self-report scale that yields a raw sum of 20-80 points, conventionally converted to a standard score of 25-100 by multiplying the raw total by 1.25. Higher standard scores denote worse outcomes: <50 normal, 50-59 mild, 60-69 moderate, and ≥70 severe depression, with ≥70 warranting specialist evaluation and suicide-risk assessment.
Measured: Up to 72 weeks.
Discontinue all treatment for CHB for 24 weeks with HBV DNA<LLOQ and HBsAg<10IU/mL.
Measured: Up to 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start8 Jun 2025
- Primary completion15 Jul 2027 (estimated)
- Study completion15 Jan 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.
- 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
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ausper Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jia, Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07069569
- Sponsor's protocol ID
- AB-10-8007
- Status last verified
- Jul 2026
- First submitted
- 25 Jun 2025
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No