Actively Recruiting
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
Led by AusperBio Therapeutics Inc. · Updated on 2026-06-01
84
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety and effectiveness of AHB-137 injection in adults with HBeAg-negative chronic hepatitis B (CHB) who have been treated with nucleos(t)ide analogue (NAs) therapy. This phase 2, randomized, open-label trial involves multiple centers in the Asia Pacific region and aims to find out whether AHB-137 can help manage this condition better. Participants will receive AHB-137 through subcutaneous injections at a dose of 300 mg weekly for 24 weeks. Two different dosing schedules are being tested: one with two loading doses on Days 4 and 11, and another with three loading doses on Days 4, 11, and 18. These treatment groups are compared to assess their effects on the participants. Throughout the study, participants will be closely monitored with regular blood tests to measure hepatitis B virus levels and liver function. The main outcome is the proportion of participants maintaining a sustained response 24 weeks after treatment. Other assessments include measuring liver enzymes, viral markers, drug levels in the blood, and any side effects. The study lasts up to 96 weeks, including treatment and follow-up periods to evaluate long-term outcomes.
CONDITIONS
Brief Title
Phase 2 Study of AHB-137 in HBeAg Negative Chronic Hepatitis B (CHB) Participants in Asia Pacific Region
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 to 65 years old able to provide informed consent and comply with study procedures
- Body mass index (BMI) of 35 kg/m² or less
- Documented chronic hepatitis B infection for at least 6 months prior to randomization
- Hepatitis B e antigen (HBeAg) negative at screening
- Receiving stable nucleos(t)ide analogue monotherapy for 6 months or more prior to randomization
- HBV DNA below the lower limit of quantification at screening
- Hepatitis B surface antigen (HBsAg) level greater than 100 IU/mL and 3,000 IU/mL or less at screening
- Alanine aminotransferase (ALT) level 2 times upper limit of normal or less at screening
- Screening ECG without significant abnormalities and QTcF ≤450 msec for males or ≤470 msec for females
- Females of childbearing potential not breastfeeding with negative pregnancy tests at screening and prior to first dose
- Male and female participants of childbearing potential agreeing to use effective contraception during dosing and for 6 months after last dose of AHB-137
You will not qualify if you...
- Clinically significant diseases other than chronic hepatitis B, including recent acute coronary syndrome, unstable cardiac disease, uncontrolled diabetes, bleeding disorders, or prior organ transplant
- Significant or unstable liver diseases other than hepatitis B, including viral hepatitis from other causes, autoimmune or alcoholic liver disease, drug-induced liver injury, or history of liver decompensation
- Severe infection within 1 month prior to randomization requiring intravenous therapy
- History of immune thrombocytopenia
- Current or suspected liver cirrhosis based on liver stiffness or biopsy
- History or suspicion of hepatocellular carcinoma or high alpha-fetoprotein levels
- Extrahepatic diseases associated with hepatitis B, such as nephrotic syndrome or uncontrolled hypertension
- Active infections with HIV, hepatitis C or D viruses, or active syphilis
- Abnormal lab values including low serum albumin, reduced kidney function, elevated INR, low platelet count, high bilirubin, or urine abnormalities
- History or signs of vasculitis or related autoimmune diseases
- History of malignancy within 5 years except treated non-melanoma skin cancer
- Allergic reactions to study drug components
- Recent major trauma or surgery or planned surgery during the study without approval
- Current alcohol or substance abuse affecting participation
- Pregnancy, breastfeeding, or planning pregnancy during the study
- Participation in other clinical trials or investigational products within specified timeframes
- Prior treatment with antisense or siRNA therapies
- Recent use of immunomodulators, interferon, vaccination (except flu or COVID-19), or bulevirtide
- Need for long-term anticoagulants or antiplatelet agents except low-dose aspirin under study conditions
- Any other condition making participation unsuitable in the investigator's judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - 24 weeks
Participants receive weekly subcutaneous injections of AHB-137 for 24 weeks with either 2 or 3 loading doses early in treatment depending on the treatment arm.
Weekly visits for 24 weeks
Duration - Up to 48 weeks post treatment
Participants are monitored for response and safety after completing AHB-137 treatment, including assessments up to 48 weeks post treatment.
Visits through Week 96 including follow-up visits at Weeks 48 and 72
Trial Site Locations
Total: 8 locations
1
St Vincents Hospital Melbourne
Fitzroy, Victoria, Australia, 3065
Actively Recruiting
2
Queen Mary Hospital - PPDS
Hong Kong, China
Actively Recruiting
3
New Zealand Clinical Research
Grafton, Auckland, New Zealand, 1010
Actively Recruiting
4
National University Hospital - Singapore
Singapore, Singapore, 119074
Not Yet Recruiting
5
Asan Medical Center
Seoul, South Korea, 05505
Not Yet Recruiting
6
Chiayi Christian Hospital
Chiayi City, Taiwan, 60002
Not Yet Recruiting
7
E-DA Hospital
Kaohsiung City, Taiwan, 82445
Not Yet Recruiting
8
National Taiwan University Hospital
Taipei, Taiwan, 100
Not Yet Recruiting
Research Team
D
Debbie Liao
T
Toll Free-North America
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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