Actively Recruiting
Phase 2 Study of AHB-137 in HBeAg Negative Chronic Hepatitis B (CHB) Participants in Asia Pacific Region
Led by AusperBio Therapeutics Inc. · Updated on 2026-04-13
84
Participants Needed
8
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 aged 18 to 65 years who can provide informed consent and comply with study procedures
- Body mass index (BMI) of 35 kg/m² or less
- Documented chronic hepatitis B virus 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 at least 6 months 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 less than or equal to 2 times the upper limit of normal at screening
- Screening electrocardiogram without significant abnormalities and with proper QT interval limits
- Females of childbearing potential must not be breastfeeding and have negative pregnancy tests at screening and before first dose
- Male and female participants of childbearing potential must agree to use effective contraception during dosing and for 6 months after last dose
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 liver diseases other than chronic hepatitis B, including viral hepatitis from other causes, hemochromatosis, Wilson's disease, autoimmune liver diseases, alcoholic liver disease, drug-induced liver injury, or history of liver decompensation
- Severe infections other than chronic hepatitis B within 1 month prior to randomization requiring intravenous therapy
- History of immune thrombocytopenia
- Suspected or confirmed liver cirrhosis based on liver stiffness measurements or biopsy
- History or suspicion of hepatocellular carcinoma or elevated alpha-fetoprotein levels
- History of extrahepatic diseases associated with hepatitis B, such as nephrotic syndrome or uncontrolled hypertension
- Active infection with HIV, hepatitis C, hepatitis D, or syphilis (except controlled cases)
- Abnormal laboratory values including low serum albumin, reduced kidney function, abnormal coagulation, low platelet count, high bilirubin, elevated urine albumin-to-creatinine ratio, or positive antineutrophil cytoplasmic antibodies requiring evaluation
- History or signs of vasculitis or related autoimmune diseases
- History of malignancy within 5 years except treated non-melanoma skin cancer
- Allergy to any component of the investigational product
- Major trauma or surgery within 3 months prior to screening or planned surgery during the study without medical clearance
- Current alcohol or substance abuse interfering with study participation
- Pregnancy, breastfeeding, planning pregnancy, or unwillingness to avoid egg donation or in vitro fertilization during the study
- Participation in another clinical trial or receipt of investigational product within defined washout periods
- Prior treatment with antisense oligonucleotides or small interfering RNA therapies
- Use of certain immunomodulators, cytotoxic drugs, biologics, interferon therapy, recent vaccination, or treatment with bulevirtide
- Requirement for long-term anticoagulants or antiplatelet agents (except low-dose aspirin under conditions)
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
St Vincents Hospital Melbourne
Fitzroy, Victoria, Australia, 3065
Not Yet Recruiting
2
Queen Mary Hospital - PPDS
Hong Kong, China
Not Yet 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
CONTACT
T
Toll Free-North America
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here