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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.

Recruiting

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

Sites and contacts
Official record
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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
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

  • 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;
Show all 23Show fewer
  • 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.

Lu contact

0571-86959519

clinicaltrial@ausperbio.com

14 sites in 1 country

China14 sites, 14 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

    Recruiting

Other trials in China

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.

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 groups in NCT07069569
Study groupRoleWhat they receive
AHB-137 (16 weeks) and Peg-IFNExperimentalNot described
Receives: Drug: AHB-137; Drug: Peg-IFN
AHB-137 (24 weeks) and Peg-IFNExperimentalNot described
Receives: Drug: AHB-137; Drug: Peg-IFN
AHB-137 and Hepatitis B vaccineExperimentalNot described
Receives: Drug: AHB-137; Drug: Hepatitis B Vaccine
AHB-137ExperimentalNot described
Receives: Drug: AHB-137
AHB-137 (24 weeks) and Peg-IFN(24 weeks)ExperimentalR3 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.

  1. 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)

  1. Proportion of participants with persistent HBsAg < LOD and HBV DNA < LLOQ .

    Measured: Up to 72 weeks

  2. Detection of the serum concentration of HBsAg, HBsAb, HBV DNA, HBV RNA, HBcrAg, HBeAb,and HBeAg.

    Measured: Up to 72 weeks

  3. Proportion of participants who met discontinuation criteria for NAs treatment at the end of the treatment period.

    Measured: Up to 48 weeks

  4. Relapse rate after discontinuation of NAs therapy.

    Measured: Up to 72 weeks

  5. Change from baseline in alanine aminotransferase (ALT) values and time to normalization of values.

    Measured: Up to 72 weeks

  6. Relapse time after discontinuation of NAs therapy.

    Measured: Up to 72 weeks

  7. Plasma concentrations of AHB-137.

    Measured: Up to 48 weeks

  8. Serum concentrations of Peg-IFN.

    Measured: Up to 48 weeks.

  9. Safety: Number and percentage of participants with detectable anti-drug antibodies (ADA).

    Measured: Up to 72 weeks

  10. 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

  11. 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

  12. 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.

  13. 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

  14. 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.

  15. 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.

  1. First posted16 Jul 2025
  2. Study start8 Jun 2025
  3. Primary completion15 Jul 2027 (estimated)
  4. Study completion15 Jan 2028 (estimated)

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

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.

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 8 inclusion and 23 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 14 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.

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?

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. (time frame: up to 72 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07069569.

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.

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