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Clinical Trials/NCT07370207
NCT07370207
Recruiting
Phase 2

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

AusperBio Therapeutics Inc.14 sites in 6 countries84 target enrollmentStarted: March 6, 2026Last updated:
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InterventionsAHB-137

Overview

Phase
Phase 2
Status
Recruiting
Enrollment
84
Locations
14
Primary Endpoint
Proportion of participants with sustained response post AHB-137 treatment
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief 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 HBeAg-negative CHB treated with NAs.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Participants are eligible to be included in the study only if all of the following criteria apply:
  • •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.
  • •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.
  • •Hepatitis B e antigen (HBeAg) negative at Screening.
  • •Receiving stable, approved nucleos(t)ide analog (NA) monotherapy for ≥6 months prior to randomization.
  • •HBV DNA below the lower limit of quantification (LLOQ) at Screening.
  • •Hepatitis B surface antigen (HBsAg) level \>100 IU/mL and ≤3,000 IU/mL at Screening.
  • •Alanine aminotransferase (ALT) ≤2 × upper limit of normal (ULN) 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.

Exclusion Criteria

  • •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, 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
  • •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).
  • •Any severe infection (other than chronic HBV infection) within 1 month prior to randomization and/or requiring intravenous anti-infective therapy.
  • •History of immune thrombocytopenia.
  • •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).
  • •History of liver cirrhosis defined by liver biopsy or by LSM \>12 kPa by FibroScan® or equivalent imaging modality.
  • •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, including but not limited to nephrotic syndrome, any form of glomerulonephritis, polyarteritis nodosa, cryoglobulinemia, or uncontrolled hypertension.
  • •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.

Arms & Interventions

Arm A: AHB-137 + 2 LDs

Experimental

AHB-137 300 mg subcutaneous (SC) weekly for 24 weeks with 2 loading doses (LDs) on Days 4 and 11

Intervention: AHB-137 (Drug)

Arm B: AHB-137 + 3 LDs

Experimental

AHB-137 300 mg SC weekly for 24 weeks with 3 LDs on Days 4, 11, and 18

Intervention: AHB-137 (Drug)

Outcomes

Primary Outcomes

Proportion of participants with sustained response post AHB-137 treatment

Time Frame: 24 Weeks post AHB-137 treatment

Sustained response defined as hepatitis B surface antigen (HBsAg) level below the limit of detection (LOD, 0.05 international units \[IU\]/mL) and HBV deoxyribonucleic acid (DNA) below the lower limit of quantification (LLOQ)

Secondary Outcomes

  • Proportion of participants with functional cure (FC)(Week 72)
  • Proportion of participants with functional cure (FC) or sustained HBV DNA response off all HBV treatment(Off-treatment follow-up (Week 48 to 96))
  • Proportion of participants with sustained HBV DNA response(From baseline through Week 72)
  • Proportion of participants with HBsAg ≤10 IU/mL and HBV DNA < Lower Limit of Quantification (LLOQ) post AHB-137 treatment(24 weeks post AHB-137 treatment)
  • Proportion of participants with HBsAg <100 IU/mL and HBV DNA < LLOQ(24 weeks post AHB-137 treatment and at Week 72)
  • Proportion of participants with complete response (CR)(From baseline through end of study (Week 96))
  • Proportion of participants with HBsAg < or ≥ LOD (0.05 IU/mL) and/or HBV DNA < or ≥ LLOQ(From baseline through end of study (Week 96))
  • Proportion of participants with ultrasensitive HBsAg < LOD (0.005 IU/mL)(From baseline through end of study (Week 96))
  • Proportion of participants with HBsAg ≤ 10 IU/mL and < 100 IU/mL(From baseline through end of study (Week 96))
  • Proportion of participants that meet nucleos(t)ide analog (NA) discontinuation criteria(Week 48)
  • Categorical change from baseline in serum hepatitis B surface antigen (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(From baseline through end of study (Week 96), assessed at each scheduled visit)
  • Proportion of participants with anti-HBs seroconversion (with hepatitis B surface antibody [HBsAb] > 10 IU/L)(Weeks 24, 48, and 72)
  • Quantitative hepatitis B virologic and serologic markers over time(From baseline through end of study (Week 96))
  • Proportion of participants who experience virologic relapse(From baseline through Week 72)
  • Time from nucleos(t)ide analog (NA) therapy discontinuation to virologic relapse(From NA therapy discontinuation (Week 48) through end of follow-up (Week 96))
  • Change from baseline in alanine aminotransferase (ALT)(From baseline through end of study (Week 96))
  • Proportion of participants with baseline ALT above the upper limit of normal (ULN) who achieve ALT normalization(From baseline through end of study (Week 96))
  • Proportion of patients with drug-resistant mutations(From baseline through end of study (Week 96))
  • Proportion of participants with treatment-emergent adverse events (TEAEs)(From first dose (Day 1) through end of study (Week 96))
  • Proportion of participants with detectable anti-drug antibody (ADA) to AHB-137 and corresponding ADA titers(From baseline through end of study (Week 96))
  • Area under the plasma concentration-time curve (AUC) of AHB-137(From first dose (Day 1) through end of pharmacokinetic sampling (Week 48))
  • Concentration at the end of the dosing interval (Ct) of AHB-137(From first dose (Day 1) through end of pharmacokinetic sampling (Week 48))
  • Maximum observed plasma concentration (Cmax) of AHB-137(From first dose (Day 1) through end of pharmacokinetic sampling (Week 48))
  • Time to maximum observed plasma concentration (Tmax) of AHB-137(From first dose (Day 1) through end of pharmacokinetic sampling (Week 48))
  • Apparent plasma clearance (CL/F) of AHB-137(From first dose (Day 1) through end of pharmacokinetic sampling (Week 48))
  • Population Pharmacokinetic and Exposure-Response Analyses of AHB-137(From first dose (Day 1) through end of study (Week 96))

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (14)

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