A Phase 2 interventional study of AHB-137 in Hepatitis B, Chronic, sponsored by AusperBio Therapeutics Inc.. Recruiting at 10 sites in 6 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by AusperBio Therapeutics Inc. · Phase 2, Interventional, and Treatment
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).
895 studies on the registry are indexed under Hepatitis B, Chronic; 151 are open to participants now.
This study's planned enrollment of 70 is below the median of 100 across 659 interventional studies indexed under Hepatitis B, Chronic.
Browse Hepatitis B, Chronic studies →AusperBio Therapeutics Inc. is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants are eligible to be included in the study only if all of the following criteria apply:
Exclusion Criteria:
Participants will be excluded from the study if any of the following criteria apply:
Participation in another clinical trial or receipt of any investigational product prior to first dose in this study within:
Any of the following prior or concomitant therapies:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive AHB-137 according to dosing regimen A.
Drug: AHB-137
Participants receive AHB-137 according to dosing regimen B.
Drug: AHB-137
Subcutaneous injection
Proportion of participants with persistent HBsAg < limit of detection (LOD) and HBV DNA < lower limit of quantification (LLOQ)
Time frame: 24 Weeks post AHB-137 treatment (Week 48)
Proportion of participants with HBsAg < LOD and HBV DNA < LLOQ
Time frame: Off-treatment follow-up (Week 48 to 72)
Proportion of participants with HBsAg < LOD
Time frame: Week 72
Proportion of participants with HBV DNA < LLOQ
Time frame: From baseline through Week 72
Proportion of participants with protocol-defined virologic response for HBsAg and HBV DNA post AHB-137 treatment
Time frame: 24 weeks post AHB-137 treatment
Proportion of participants with protocol-defined virologic response for HBsAg and HBV DNA at weeks 48 and 72
Time frame: 24 weeks post AHB-137 treatment and at Week 72
Proportion of participants with protocol-defined virologic response for HBsAg and HBV DNA
Time frame: 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
Time frame: From baseline through end of study (Week 72)
Proportion of participants with highly sensitive HBsAg < LOD (0.005 IU/mL)
Time frame: From baseline through end of study (Week 72)
Proportion of participants with protocol-defined levels of HBsAg
Time frame: From baseline through end of study (Week 72)
Proportion of participants that meet nucleos(t)ide analog (NA) discontinuation criteria
Time frame: 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
Time frame: From baseline through end of study (Week 72)
Proportion of participants with anti-HBs seroconversion (with hepatitis B surface antibody [HBsAb] > 10 IU/L)
Time frame: 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.
Time frame: From baseline through end of study (Week 72)
Proportion of participants who experience virologic relapse
Time frame: From baseline through Week 72
Time from nucleos(t)ide analog (NA) therapy discontinuation to virologic relapse
Time frame: From NA therapy discontinuation (Week 48) through end of follow-up (Week 72)
Change from baseline in alanine aminotransferase (ALT)
Time frame: 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
Time frame: From baseline through end of study (Week 72)
Proportion of patients with drug-resistant mutations
Time frame: 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.
Time frame: 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
Time frame: From baseline through end of study (Week 72)
Area under the plasma concentration-time curve (AUC) of AHB-137
Time frame: From first dose (Day 1) through end of pharmacokinetic sampling (Week 48)
Concentration at the end of the dosing interval (Ct) of AHB-137
Time frame: From first dose (Day 1) through end of pharmacokinetic sampling (Week 48)
Maximum observed plasma concentration (Cmax) of AHB-137
Time frame: From first dose (Day 1) through end of pharmacokinetic sampling (Week 48)
Time to maximum observed plasma concentration (Tmax) of AHB-137
Time frame: From first dose (Day 1) through end of pharmacokinetic sampling (Week 48)
Apparent plasma clearance (CL/F) of AHB-137
Time frame: From first dose (Day 1) through end of pharmacokinetic sampling (Week 48)
Area Under the Plasma Concentration-Time Curve (AUC) of AHB-137
Time frame: From first dose (Day 1) through end of study (Week 72)
Plasma Concentration of AHB-137 at the End of the Dosing Interval (Cτ)
Time frame: From first dose (Day 1) through end of study (Week 72)
Maximum Observed Plasma Concentration (Cmax) of AHB-137
Time frame: From first dose (Day 1) through end of study (Week 72)
Time to Maximum Observed Plasma Concentration (Tmax) of AHB-137
Time frame: From first dose (Day 1) through end of study (Week 72)
Apparent Plasma Clearance (CL/F) of AHB-137
Time frame: From first dose (Day 1) through end of study (Week 72)
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Hepatitis B Virus Antisense Oligonucleotide AHB-137
AusperBio Therapeutics Inc.