Hepatitis B, ChronicPhase 2ASPIRE-202NCT07654283
Study of AHB-137 in Chronic Hepatitis B (CHB) Participants in North America and Europe Regions
A Phase 2 study testing AHB-137 in people with Hepatitis B, Chronic, run by AusperBio Therapeutics Inc. at 10 sites in 6 countries.
Trial summary
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 CHB treated with Nucleos(t)ide Analogue (NAs). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- AHB-137
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 10 sitesin 6 countries
- Study dates
- 1 Sep 2026to 26 Jul 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 are eligible to be included in the study only if all of the following criteria apply:
- Adults ≥18 years of age and up to 65 years of age (inclusive) 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.
- Body mass index (BMI) ≤35 kg/m².
- 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.
- Receiving stable, approved nucleos(t)ide analog (NA) monotherapy for ≥6 months prior to randomization.
- HBV DNA meeting protocol-specified virologic criteria at Screening.
Show all 11Show fewer
- Hepatitis B surface antigen (HBsAg) level meeting protocol-specified virologic criteria at Screening.
- Alanine aminotransferase (ALT) meeting protocol-specified criteria at Screening.
- Screening electrocardiogram (ECG) without clinically significant abnormalities and with a Fridericia-corrected QT interval (QTcF) ≤450 msec for males or ≤470 msec for females.
- 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.
- Males 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 cannot join
- Participants will be excluded from the study if any of the following criteria apply:
- Clinically significant disease other than chronic hepatitis B virus (HBV) infection.
- Concomitant clinically significant liver disease.
- Any severe infection (other than chronic HBV infection) within 1 month prior to randomization.
- History of immune thrombocytopenia.
- Current suspected liver cirrhosis and/or evidence of cirrhosis by protocol-specified criteria for FibroScan® or equivalent imaging modality (e.g., ultrasound elastography); historical FibroScan® (or equivalent) results with documentation within 6 months from screening is acceptable.
Show all 28Show fewer
- History of liver cirrhosis defined by liver biopsy or by FibroScan® or equivalent imaging modality using protocol-specified criteria.
- Prior history of, current diagnosis of, or suspected hepatocellular carcinoma (HCC), or alpha-fetoprotein (AFP) ≥20 ng/mL at Screening.
- History of extrahepatic diseases potentially associated with HBV infection.
- 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.
- Protocol-specified abnormal laboratory values at Screening.
- History of vasculitis or presence of signs or symptoms suggestive of vasculitis, or history or presence of diseases associated with vasculitis.
- 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.
- History of hypersensitivity or allergy to any component of the investigational product (IP).
- 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.
- Current alcohol or substance abuse judged by the Investigator to potentially interfere with participant compliance.
- 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.
- Participation in another clinical trial or receipt of any investigational product prior to first dose in this study within:
- Five half-lives (if known) or twice the duration of biological effect (if known), whichever is longer, or
- Six months, if neither half-life nor duration of effect is known
- Prior treatment with antisense oligonucleotides (ASOs) or small interfering RNA (siRNA)-based therapies.
- Any of the following prior or concomitant therapies:
- 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
- Interferon therapy within 12 months prior to first dose
- Vaccination within 1 month prior to Screening, except for influenza or SARS-CoV-2 (COVID-19) vaccination or booster
- Current treatment with bulevirtide
- 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.
- Any other condition or circumstance that, in the Investigator's judgment, would make the participant unsuitable for participation in the study.
Trial locations and contacts
10 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 6 countries
United States4 sites, 4 recruiting
- Not yet recruiting
University of Maryland
Baltimore, Maryland, 21201-1009
- Not yet recruiting
NYU Langone Health
New York, New York, 10016
- Not yet recruiting
Stanford University
Palo Alto, California, 94304-1509
- Recruiting
Texas Liver Institute
San Antonio, Texas, 78215-2100
Canada2 sites, 2 recruiting
- Not yet recruiting
University of Calgary
Calgary, Alberta, T2N 4N1
- Not yet recruiting
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Italy1 site, 1 recruiting
- Not yet recruiting
Clinica Mangiagalli
Milan, Milan, 20122
Spain1 site, 1 recruiting
- Not yet recruiting
Vall d'Hebron Hospital
Barcelona, Barcelona, 8035
United Kingdom1 site, 1 recruiting
- Not yet recruiting
King's College Hospital
London, London, SE5 9RS
About this study
Official title: 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 Chronic Hepatitis B in the North America and Europe Regions
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 CHB treated with Nucleos(t)ide Analogue (NAs).
- Conditions
- Hepatitis B, Chronic
- Being tested
- AHB-137
- Keywords
- Hepatitis, Chronic Hepatitis, Chronic Hepatitis B, Hepatitis B, Hepatitis B, Chronic, Hepatitis B Virus, hepatitis B virus e-antigen, AHB-137, Nucleos(t)ide analogue, Nucleos(t)ide analog, Antisense Oligonucleotide, Blood-Borne Infections, Communicable Diseases, Infections, DNA Virus Infections, Virus Diseases, Hepatitis, Viral, Human, Liver Diseases, Digestive System Diseases, Chronic Disease
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis, Hepatitis, Chronic, Hepatitis B, Blood-Borne Infections, Communicable Diseases, Infections, DNA Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AHB-137Drug
Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Dose Regimen A | Experimental | Participants receive AHB-137 according to dosing regimen A. Receives: Drug: AHB-137 |
| Arm B: Dose Regimen B | Experimental | Participants receive AHB-137 according to dosing regimen B. Receives: Drug: AHB-137 |
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)
Measured: 24 Weeks post AHB-137 treatment (Week 48)
Secondary outcomes (30)
Proportion of participants with HBsAg < LOD and HBV DNA < LLOQ
Measured: Off-treatment follow-up (Week 48 to 72)
Proportion of participants with HBsAg < LOD
Measured: Week 72
Proportion of participants with HBV DNA < LLOQ
Measured: From baseline through Week 72
Proportion of participants with protocol-defined virologic response for HBsAg and HBV DNA post AHB-137 treatment
Measured: 24 weeks post AHB-137 treatment
Proportion of participants with protocol-defined virologic response for HBsAg and HBV DNA at weeks 48 and 72
Measured: 24 weeks post AHB-137 treatment and at Week 72
Proportion of participants with protocol-defined virologic response for HBsAg and HBV DNA
Measured: From baseline through end of study (Week 72)
Proportion of participants with HBsAg < or ≥ LOD (0.05 IU/mL) and/or HBV DNA < or ≥ LLOQ
Measured: From baseline through end of study (Week 72)
Proportion of participants with highly sensitive HBsAg < LOD (0.005 IU/mL)
Measured: From baseline through end of study (Week 72)
Proportion of participants with protocol-defined levels of HBsAg
Measured: From baseline through end of study (Week 72)
Proportion of participants that meet nucleos(t)ide analog (NA) discontinuation criteria
Measured: Week 48
Categorical change from baseline in HBsAg levels, defined as reductions of ≥0.5, ≥1.0, ≥1.5, ≥2.0, or ≥3.0 log₁₀ IU/mL, assessed at each scheduled study visit
Measured: From baseline through end of study (Week 72)
Proportion of participants with anti-HBs seroconversion (with hepatitis B surface antibody [HBsAb] > 10 IU/L)
Measured: Weeks 24, 48, and 72
Quantitative hepatitis B virologic and serologic markers over time
Actual values and change from baseline over time in available quantitative hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), hepatitis B virus (HBV) DNA, HBV ribonucleic acid (RNA), hepatitis B core-related antigen (HBcrAg), hepatitis B e antibody (HBeAb), and qualitative and/or quantitative hepatitis B e antigen (HBeAg), summarized descriptively.
Measured: From baseline through end of study (Week 72)
Proportion of participants who experience virologic relapse
Measured: From baseline through Week 72
Time from nucleos(t)ide analog (NA) therapy discontinuation to virologic relapse
Measured: From NA therapy discontinuation (Week 48) through end of follow-up (Week 72)
Change from baseline in alanine aminotransferase (ALT)
Measured: From baseline through end of study (Week 72)
Proportion of participants with baseline ALT above the upper limit of normal (ULN) who achieve ALT normalization
Measured: From baseline through end of study (Week 72)
Proportion of patients with drug-resistant mutations
Measured: From baseline through end of study (Week 72)
Proportion of participants with treatment-emergent adverse events (TEAEs)
Proportion of participants who experience treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events leading to discontinuation of study treatment.
Measured: From first dose (Day 1) through end of study (Week 72)
Proportion of participants with detectable anti-drug antibody (ADA) to AHB-137 and corresponding ADA titers
Measured: From baseline through end of study (Week 72)
Area under the plasma concentration-time curve (AUC) of AHB-137
Measured: From first dose (Day 1) through end of pharmacokinetic sampling (Week 48)
Concentration at the end of the dosing interval (Ct) of AHB-137
Measured: From first dose (Day 1) through end of pharmacokinetic sampling (Week 48)
Maximum observed plasma concentration (Cmax) of AHB-137
Measured: From first dose (Day 1) through end of pharmacokinetic sampling (Week 48)
Time to maximum observed plasma concentration (Tmax) of AHB-137
Measured: From first dose (Day 1) through end of pharmacokinetic sampling (Week 48)
Apparent plasma clearance (CL/F) of AHB-137
Measured: From first dose (Day 1) through end of pharmacokinetic sampling (Week 48)
Area Under the Plasma Concentration-Time Curve (AUC) of AHB-137
Measured: From first dose (Day 1) through end of study (Week 72)
Plasma Concentration of AHB-137 at the End of the Dosing Interval (Cτ)
Measured: From first dose (Day 1) through end of study (Week 72)
Maximum Observed Plasma Concentration (Cmax) of AHB-137
Measured: From first dose (Day 1) through end of study (Week 72)
Time to Maximum Observed Plasma Concentration (Tmax) of AHB-137
Measured: From first dose (Day 1) through end of study (Week 72)
Apparent Plasma Clearance (CL/F) of AHB-137
Measured: From first dose (Day 1) through end of study (Week 72)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start1 Sep 2026
- Primary completion11 May 2027 (estimated)
- Study completion26 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B, ChronicStudies 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AusperBio Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Audrey Lau, MD, PhD, Study director, AusperBio Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07654283
- Sponsor's protocol ID
- AB-10-8012
- Other IDs
- 2025-524159-30-00, 2025
- Acronym
- ASPIRE-202
- Status last verified
- Sep 2026
- First submitted
- 28 May 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No