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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Phase 2 Study of AHB-137 in HBeAg Negative Chronic Hepatitis B (CHB) Participants in Asia Pacific Region

A Phase 2 Multi-center, Randomized, Open-label Study to Assess the Efficacy and Safety of AHB-137 in Nucleos(t)Ide Analogue-treated Participants With HBeAg Negative Chronic Hepatitis B in the Asia Pacific Region

Phase 2 Study of AHB-137 in HBeAg Negative Chronic Hepatitis B (CHB) Participants in Asia Pacific Region (NCT07370207) is a Phase 2 interventional studying Hepatitis B, Chronic, sponsored by AusperBio Therapeutics Inc.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This study is a randomized, open-label, multicenter phase 2 clinical trial to evaluate the efficacy and safety of AHB-137 injection in participants with HBeAg-negative CHB treated with NAs.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Hepatitis B, Chronic and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 84 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Hepatitis B, Chronic subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: Participants are eligible to be included in the study only if all of the following criteria apply: 1. Adults ≥18 years of age (or per local age of majority) and ≤65 years of age at Screening who are able to provide willing to sign a consent form, comply with study procedures, and agree to discontinue nucleos(t)ide analog (NA) therapy if protocol-defined discontinuation criteria are met. 2. Body mass index (BMI) ≤35 kg/m². 3. Documented chronic hepatitis B virus (HBV) infection for ≥6 months prior to randomization, defined by hepatitis B surface antigen (HBsAg) positivity or detectable HBV DNA. 4. Hepatitis B e antigen (HBeAg) negative at Screening. 5. Receiving stable, approved nucleos(t)ide analog (NA) monotherapy for ≥6 months prior to randomization. 6. HBV DNA below the lower limit of quantification (LLOQ) at Screening. 7. Hepatitis B surface antigen (HBsAg) level \>100 IU/mL and ≤3,000 IU/mL at Screening. 8. Alanine aminotransferase (ALT) ≤2 × upper limit of normal (ULN) at Screening. 9. Screening electrocardiogram (ECG) without clinically significant abnormalities and with a Fridericia-corrected QT interval (QTcF) ≤450 msec for males or ≤470 msec for females. 10. Females of childbearing potential must not be breastfeeding and must have a negative serum pregnancy test at Screening and a negative urine pregnancy test prior to first dose. 11. Male and female participants of childbearing potential must agree to use protocol-specified effective contraception during the dosing period and for ≥6 months after the last dose of AHB-137. Who Should NOT Join This Trial: Participants will be excluded from the study if any of the following criteria apply: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: 1. Adults ≥18 years of age (or per local age of majority) and ≤65 years of age at Screening who are able to provide informed consent, comply with study procedures, and agree to discontinue nucleos(t)ide analog (NA) therapy if protocol-defined discontinuation criteria are met. 2. Body mass index (BMI) ≤35 kg/m². 3. Documented chronic hepatitis B virus (HBV) infection for ≥6 months prior to randomization, defined by hepatitis B surface antigen (HBsAg) positivity or detectable HBV DNA. 4. Hepatitis B e antigen (HBeAg) negative at Screening. 5. Receiving stable, approved nucleos(t)ide analog (NA) monotherapy for ≥6 months prior to randomization. 6. HBV DNA below the lower limit of quantification (LLOQ) at Screening. 7. Hepatitis B surface antigen (HBsAg) level \>100 IU/mL and ≤3,000 IU/mL at Screening. 8. Alanine aminotransferase (ALT) ≤2 × upper limit of normal (ULN) at Screening. 9. Screening electrocardiogram (ECG) without clinically significant abnormalities and with a Fridericia-corrected QT interval (QTcF) ≤450 msec for males or ≤470 msec for females. 10. Females of childbearing potential must not be breastfeeding and must have a negative serum pregnancy test at Screening and a negative urine pregnancy test prior to first dose. 11. Male and female participants of childbearing potential must agree to use protocol-specified effective contraception during the dosing period and for ≥6 months after the last dose of AHB-137. Exclusion Criteria: Participants will be excluded from the study if any of the following criteria apply: 1. Clinically significant disease other than chronic hepatitis B virus (HBV) infection, as documented in medical history or identified on physical examination, including but not limited to acute coronary syndrome within 6 months prior to Screening, significant or unstable cardiac disease, uncontrolled diabetes, bleeding diathesis or coagulopathy, or prior solid organ or bone marrow transplant 2. Concomitant clinically significant liver disease, including but not limited to viral hepatitis caused by other pathogens, hemochromatosis, Wilson's disease, primary biliary cholangitis, autoimmune liver disease, alcoholic liver disease, drug-induced liver injury, or current or prior history of clinical hepatic decompensation (e.g., ascites, encephalopathy, hepatorenal syndrome, or variceal hemorrhage). 3. Any severe infection (other than chronic HBV infection) within 1 month prior to randomization and/or requiring intravenous anti-infective therapy. 4. History of immune thrombocytopenia. 5. Current suspected liver cirrhosis and/or evidence of cirrhosis defined as liver stiffness measurement (LSM) \>9 kPa by FibroScan® or equivalent imaging modality (e.g., ultrasound elastography). 6. History of liver cirrhosis defined by liver biopsy or by LSM \>12 kPa by FibroScan® or equivalent imaging modality. 7. Prior history of, current diagnosis of, or suspected hepatocellular carcinoma (HCC), or alpha-fetoprotein (AFP) ≥20 ng/mL at Screening. 8. History of extrahepatic diseases potentially associated with HBV infection, including but not limited to nephrotic syndrome, any form of glomerulonephritis, polyarteritis nodosa, cryoglobulinemia, or uncontrolled hypertension. 9. Laboratory evidence of active infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis D virus (HDV), or active syphilis. Participants with positive HCV or HDV serology and documented negative HCV RNA or HDV RNA, respectively, are eligible. 10. Abnormal laboratory values at Screening meeting any of the following criteria: 1. Serum albumin \<3.5 g/dL 2. Estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m² calculated using the CKD-EPI equation (or JSN-CKDI equation for participants in Japan) 3. International normalized ratio (INR) \>1.25 4. Platelet count \<125 × 10⁹/L 5. Total bilirubin \>1.5 × upper limit of normal (ULN). Participants with benign unconjugated hyperbilirubinemia (Gilbert's syndrome) may be enrolled if deemed eligible by the Investigator 6. Urine albumin-to-creatinine ratio (uACR) \>0.3 mg/mg (300 mg/g) on two consecutive measurements following a positive or weakly positive urine protein result on routine urinalysis 7. Borderline positive or positive antineutrophil cytoplasmic antibody (ANCA) results requiring further evaluation (MPO-ANCA and PR3-ANCA). Eligibility requires review of complete medical history and confirmation of no past or current vasculitic, inflammatory, or autoimmune disease by the Sponsor or Sponsor-designated Medical Monitor 11. History of vasculitis or presence of signs or symptoms suggestive of vasculitis (e.g., vasculitic rash, skin ulceration, unexplained recurrent hematuria), or history or presence of diseases associated with vasculitis (e.g., systemic lupus erythematosus, rheumatoid arthritis, relapsing polychondritis, mononeuritis multiplex). 12. History of malignancy within 5 years prior to Screening, except for adequately treated non-melanoma skin cancer. Participants currently undergoing evaluation for potential malignancy are excluded. 13. History of hypersensitivity or allergy to any component of the investigational product (IP). 14. Major trauma or major surgery within 3 months prior to Screening, or planned surgery during the study period unless eligibility is confirmed by the Medical Monitor. 15. Current alcohol or substance abuse that, in the Investigator's judgment, may interfere with study participation or compliance. 16. Female participants who are pregnant, breastfeeding, planning pregnancy during the study, or unwilling to refrain from egg donation and/or in vitro fertilization during the study. 17. Participation in another clinical trial or receipt of any investigational product prior to first dose in this study within: 1. Five half-lives (if known) or twice the duration of biological effect (if known), whichever is longer, or 2. Six months, if neither half-life nor duration of effect is known 18. Prior treatment with antisense oligonucleotides (ASOs) or small interfering RNA (siRNA)-based therapies. 19. Any of the following prior or concomitant therapies: 1. Prolonged use of immunomodulators (e.g., corticosteroids, methotrexate), cytotoxic drugs, or biologics (e.g., monoclonal antibodies) within 6 months prior to first IP administration, except for short-term treatment (≤2 weeks) or topical/inhaled corticosteroids 2. Interferon therapy within 12 months prior to first dose 3. Vaccination within 1 month prior to Screening, except for influenza or SARS-CoV-2 (COVID-19) vaccination or booster 4. Current treatment with bulevirtide 20. Requirement for long-term regular use of anticoagulants (e.g., warfarin, factor Xa inhibitors) or antiplatelet agents (e.g., clopidogrel or regular aspirin), except for low-dose aspirin, unless the Investigator determines the medication can be safely discontinued prior to first IP administration. Participants taking low-dose aspirin must agree to discontinue use during the study if protocol-specified conditions are met. 21. Any other condition or circumstance that, in the Investigator's judgment, would make the participant unsuitable for participation in the study.

Treatments Being Tested

DRUG

AHB-137

Subcutaneous injection

Locations (8)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

St Vincents Hospital Melbourne
Fitzroy, Victoria, Australia
Queen Mary Hospital - PPDS
Hong Kong, China
New Zealand Clinical Research
Grafton, Auckland, New Zealand
National University Hospital - Singapore
Singapore, Singapore
Asan Medical Center
Seoul, South Korea
Chiayi Christian Hospital
Chiayi City, Taiwan
E-DA Hospital
Kaohsiung City, Taiwan
National Taiwan University Hospital
Taipei, Taiwan

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07370207), the sponsor (AusperBio Therapeutics Inc.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07370207 clinical trial studying?

This study is a randomized, open-label, multicenter phase 2 clinical trial to evaluate the efficacy and safety of AHB-137 injection in participants with HBeAg-negative CHB treated with NAs. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07370207?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07370207?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07370207. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07370207. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.