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
EU CTIS ID: 2025-524159-30-00
What this study is testing
To assess the efficacy of AHB-137 in CHB participants receiving nucleos(t)ide analogue (NA) therapy
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1) Consenting adults ≥ 18 years and up to 65 years (inclusive) based on the date of the Screening date visit who are capable of and willing to complete all study assessments and agree to discontinue NA therapy if meeting NA discontinuation criteria
- 10) Males and female participants of childbearing potential must agree to use protocol specified reliable contraception throughout the dosing period and for at least 6 months after the last dose of AHB-137
- 2) Body Mass Index (BMI) ≤ 35 kg/m2
- 3)Documented evidence of chronic HBV defined as HBsAg positivity or HBV DNA positivity for at least 6 months prior to randomization
- 4) On stable approved NA monotherapy (entecavir [ETV], tenofovir disoproxil fumarate [TDF], tenofovir disoproxil maleate [TDM], or tenofovir alafenamide [TAF]) for at least 6 months prior to randomization
- 5) XX (per central lab testing)
You likely can't join if
- 1) Clinically significant disease, aside from chronic HBV infection, in medical history (including, but not limited to acute coronary syndrome within 6 months of screening, significant/unstable cardiac disease, uncontrolled diabetes, bleeding diathesis or coagulopathy, prior solid organ or bone marrow transplant) or evident on physical examination
- 10) Laboratory results as follows: XX
- 11) History of vasculitis or presence of symptoms and signs of potential vasculitis (e.g. vasculitic rash, skin ulceration, repeated blood detected in urine without identified cause) or history/presence of other diseases that may be associated with vasculitis (e.g. systemic lupus erythematosus, rheumatoid arthritis, relapsing polychondritis, mononeuritis multiplex)
- 12) History of malignancy within the past 5 years other than non-melanoma skin cancer. Participants currently undergoing evaluation for potential malignancy are not eligible
- 13) History of allergy to any component of the IP
- 14) Participants who have experienced major trauma or undergone major surgery within 3 months prior to screening, or for any participant planning a surgery during the trial, contact the Medical Monitor for a decision regarding their eligibility.
See the full eligibility criteria
Who can join
- 1) Consenting adults ≥ 18 years and up to 65 years (inclusive) based on the date of the Screening date visit who are capable of and willing to complete all study assessments and agree to discontinue NA therapy if meeting NA discontinuation criteria
- 10) Males and female participants of childbearing potential must agree to use protocol specified reliable contraception throughout the dosing period and for at least 6 months after the last dose of AHB-137
- 2) Body Mass Index (BMI) ≤ 35 kg/m2
- 3)Documented evidence of chronic HBV defined as HBsAg positivity or HBV DNA positivity for at least 6 months prior to randomization
- 4) On stable approved NA monotherapy (entecavir [ETV], tenofovir disoproxil fumarate [TDF], tenofovir disoproxil maleate [TDM], or tenofovir alafenamide [TAF]) for at least 6 months prior to randomization
- 5) XX (per central lab testing)
- 6) XX (per central lab testing)
- 7) XX (per central lab testing)
- 8) Screening electrocardiogram (ECG) without clinically significant abnormalities and with QT corrected using Fridericia’s formula (QTcF) interval ≤ 450 msec (male) or ≤ 470 msec (female) as corrected by Fridericia’s formula
- 9) Females of childbearing potential (FOCBP) must be non-lactating and have a negative serum pregnancy test at Screening and a negative urine pregnancy test at baseline prior to dosing
What rules you out
- 1) Clinically significant disease, aside from chronic HBV infection, in medical history (including, but not limited to acute coronary syndrome within 6 months of screening, significant/unstable cardiac disease, uncontrolled diabetes, bleeding diathesis or coagulopathy, prior solid organ or bone marrow transplant) or evident on physical examination
- 10) Laboratory results as follows: XX
- 11) History of vasculitis or presence of symptoms and signs of potential vasculitis (e.g. vasculitic rash, skin ulceration, repeated blood detected in urine without identified cause) or history/presence of other diseases that may be associated with vasculitis (e.g. systemic lupus erythematosus, rheumatoid arthritis, relapsing polychondritis, mononeuritis multiplex)
- 12) History of malignancy within the past 5 years other than non-melanoma skin cancer. Participants currently undergoing evaluation for potential malignancy are not eligible
- 13) History of allergy to any component of the IP
- 14) Participants who have experienced major trauma or undergone major surgery within 3 months prior to screening, or for any participant planning a surgery during the trial, contact the Medical Monitor for a decision regarding their eligibility.
- 15) Current alcohol or substance abuse judged by the Investigator to potentially interfere with participant compliance
- 16) Female participants who are breastfeeding, pregnant, who wish to become pregnant during the study, or are unwilling to refrain from egg donation and/or in vitro fertilization during the study
- 17) Participants currently participating in other clinical trials, or who have received any IP within the following timeframe prior to the first dose of the IP in this trial: a. 5 half-lives (if known), or twice the duration of the biological effect of the study treatment (if known) (whichever is longer), or b. 6 months (if neither the half-life nor the duration of effect is known)
- 18) Prior receipt of antisense oligonucleotide (ASO) or have undergone treatment with small interfering RNAs (siRNA)
- 19) Participants meeting any of the following criteria: a. Received prolonged therapy with immunomodulators (e.g., corticosteroids, methotrexate), cytotoxic drugs, or biologics (e.g., monoclonal antibodies) within 6 months prior to the first IP administration except for: i. Short term courses (≤ 2 weeks) ii. Topical/inhaled corticosteroids b. Treatment with interferon within 12 months prior to the first dose c. Vaccination within 1 month prior to screening other than influenza or Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2; COVID) vaccination/booster d. On treatment with bulevirtide
- 2) Concomitant clinically significant liver disease, including but not limited to hepatitis caused by other pathogens, hemochromatosis, Wilson’s disease, primary biliary cholangitis, autoimmune liver disease, alcoholic liver disease, drug induced liver injury, current or prior history of clinical hepatic decompensation (e.g., ascites, encephalopathy, hepatorenal syndrome, or variceal hemorrhage)
- 20) Participants who require long-term regular use of anticoagulants (e.g. warfarin, factor Xa inhibitors) or antiplatelet drugs (e.g. clopidogrel or regular aspirin; single exception is use of low-dose aspirin), unless the Investigator determines that the treatment can be safely discontinued prior to the first administration of the investigational drug without increasing risk to the patient. XX
- 21) Any other conditions or circumstance that, in the Investigator’s judgment, makes the participant unsuitable for participation in this trial
- 3) Participants who experienced any severe infection (other than chronic HBV infection) within 1 month prior to randomization and/or required intravenous anti-infective therapy
- 4) History of immune thromobocytopenia
- 5) Current suspected liver cirrhosis and/or evidence of cirrhosis as determined by XX by FibroScan® or equivalent (i.e., ultrasound elastography); historical FibroScan® (or equivalent) results with documentation within 6 months from screening is acceptable
- 6) History of cirrhosis as determined by liver biopsy or XX by FibroScan® or equivalent
- 7) Participants with prior history of, current diagnosis of, or suspected hepatocellular carcinoma (HCC), or those with alpha-fetoprotein (AFP) ≥ 20 ng/mL at screening
- 8) History of extrahepatic diseases potentially associated with HBV (e.g. nephrotic syndrome, any type of glomerulonephritis, polyarteritis nodosa, cryoglobulinemia, uncontrolled hypertension)
- 9) Laboratory evidence of active infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis Delta virus (HDV) or active syphilis. Participants with positive HCV or HDV serology but have a documented negative HCV RNA or HDV RNA, respectively, are permitted
The study team makes the final eligibility decision.
Where it's taking place
- France
- United States
- Canada
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include France; United States; Canada; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from EU CTIS. The study team decides eligibility, and your own doctor gives medical advice.