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A Study to Evaluate the Effectiveness and Safety of AHB‑137 in Adults with Chronic Hepatitis B Already Treated with Nucleos(t)ide Analogue Therapy

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

Chronic Hepatitis B is a long‑lasting infection of the liver caused by the hepatitis B virus. Over time it can damage the liver and lead to serious health problems. Many people with this condition take medicines known as nucleos(t)ide analogue drugs, which keep the virus at low levels. In this study participants will receive an experimental medicine called AHB-137, which is given as a small injection under the skin.

The purpose of the study is to assess how well AHB-137 works and how safe it is when added to the usual nucleos(t)ide analogue therapy. Participants will continue their regular medication, receive the injection at scheduled visits, and attend clinic appointments where blood tests will measure HBsAg (a protein that indicates the presence of the virus) and HBV DNA (the virus’s genetic material). Over several months doctors will watch for any side effects and track changes in liver blood tests to understand the treatment’s impact.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Screening and Baseline Assessments

    You will undergo a series of tests to confirm that you have chronic hepatitis B and are currently receiving nucleos(t)ide analogue (NA) therapy. NA therapy is the standard oral medication used to control hepatitis B virus.

    Blood samples will be taken to measure hepatitis B surface antigen (HBsAg), hepatitis B virus DNA (HBV DNA), liver enzymes such as alanine aminotransferase (ALT), and other markers that help determine the activity of the infection.

  2. Step 2

    Randomization and Continuation of NA Therapy

    After the baseline tests, you will be randomly assigned to receive the study medication while continuing your current NA therapy. Randomization means that the assignment is done by chance to ensure unbiased results.

    Your existing NA medication will not be changed unless a specific study rule requires discontinuation later in the trial.

  3. Step 3

    Start of Study Medication – AHB-137 Injection

    You will receive AHB-137, which is administered by a subcutaneous injection (injection under the skin). The prescribed amount is 300 mg per dose.

    The exact schedule for the injections (for example, weekly or monthly) will be followed according to the study protocol, and you will be instructed on each visit when the next injection is due.

  4. Step 4

    Regular Clinic Visits for Laboratory Tests and Safety Monitoring

    At each scheduled visit, you will have blood drawn to check levels of HBsAg, HBV DNA, ALT, and other laboratory markers such as hepatitis B core‑related antigen (HBcrAg) and hepatitis B e antigen (HBeAg).

    Your doctor will also ask about any new symptoms or side effects. These are recorded as treatment‑emergent adverse events (TEAEs) and serious adverse events (SAEs) if they are severe.

  5. Step 5

    Evaluation of Treatment Response

    The study will assess whether the HBsAg level falls below the detection limit (0.05 IU/mL) and whether HBV DNA becomes undetectable. Achieving both goals is considered a sustained response.

    Additional outcomes include functional cure, complete response, and normalization of ALT levels. These evaluations are performed at each visit according to the study timetable.

  6. Step 6

    End of Treatment and Follow‑Up

    When the planned treatment period ends, you will have a final set of laboratory tests to determine the overall effect of AHB-137.

    After the last dose, you will continue to be monitored for a defined follow‑up period to observe any delayed effects and to ensure your safety.

Who can join the trial?

10 criteria

  • You must be an adult aged 18 to 65 years, able to give consent, able to complete all study visits, and willing to stop your current hepatitis B medication if the study requires it.
  • Your Body Mass Index (BMI) – a calculation that compares your weight to your height – must be 35 or lower.
  • You need documented proof of chronic hepatitis B, shown by a positive HBsAg test (a marker of infection) or a positive HBV DNA test (detects the virus’s genetic material) for at least six months before joining the study.
  • You must have been taking a stable, approved single‑drug hepatitis B treatment (one of the following: entecavir (ETV), tenofovir disoproxil fumarate (TDF), tenofovir disoproxil maleate (TDM), or tenofovir alafenamide (TAF)) for at least six months before randomization.
  • You must meet specific laboratory test results that will be checked by the central laboratory (details will be provided by the study team).
  • You must meet additional specific laboratory test results that will be checked by the central laboratory (details will be provided by the study team).
  • You must meet further specific laboratory test results that will be checked by the central laboratory (details will be provided by the study team).
  • You need a screening electrocardiogram (ECG) – a heart rhythm test – that shows no serious problems, and the QT interval corrected by Fridericia’s formula (QTcF) must be 450 milliseconds or less for men and 470 milliseconds or less for women.
  • If you are a female who could become pregnant, you must not be breastfeeding and must have a negative blood pregnancy test at screening and a negative urine pregnancy test at the start of treatment.
  • All participants who could become pregnant (both men and women) must agree to use reliable birth control methods as specified by the study during the treatment period and for at least six months after the last dose.

Who cannot join the trial?

21 criteria

  • Significant other health problems: Having a serious disease besides chronic hepatitis B, such as a recent heart attack (called acute coronary syndrome) within the last 6 months, unstable heart disease, uncontrolled diabetes, a bleeding disorder (difficulty clotting blood), or having received a solid‑organ or bone‑marrow transplant.
  • Other liver diseases: Having liver problems other than hepatitis B, including hepatitis from other viruses, iron overload (hemochromatosis), copper overload (Wilson’s disease), primary biliary cholangitis, autoimmune liver disease, alcohol‑related liver disease, drug‑induced liver injury, or a history of liver failure signs such as fluid buildup in the abdomen, confusion, kidney problems, or bleeding from enlarged veins.
  • Recent severe infection: Having any serious infection (not hepatitis B) within the past month or needing intravenous antibiotics.
  • Immune thrombocytopenia: A condition where the immune system lowers the number of platelets, which help blood clot.
  • Suspected or confirmed cirrhosis: Current suspicion of liver cirrhosis or evidence of cirrhosis on imaging tests (e.g., FibroScan), unless a recent test within 6 months is available.
  • Confirmed cirrhosis: Prior diagnosis of cirrhosis based on a liver biopsy or FibroScan results.
  • Liver cancer or high AFP: Having or being suspected of having liver cancer (hepatocellular carcinoma, HCC) or a high level of alpha‑fetoprotein (AFP) ≥ 20 ng/mL at screening.
  • Other diseases linked to hepatitis B: Conditions outside the liver such as severe kidney disease (nephrotic syndrome or glomerulonephritis), polyarteritis nodosa, cryoglobulinemia, or uncontrolled high blood pressure.
  • Active infections: Positive lab tests for HIV, hepatitis C, hepatitis D, or active syphilis (unless hepatitis C or D RNA is negative).
  • Abnormal laboratory results: Lab values that fall outside the study’s allowed ranges (as defined by the investigators).
  • Vasculitis or related diseases: History or signs of inflammation of blood vessels (vasculitis) such as rash, skin ulcers, or unexplained blood in the urine, or having diseases that can cause vasculitis like systemic lupus erythematosus, rheumatoid arthritis, relapsing polychondritis, or mononeuritis multiplex.
  • Recent cancer: Diagnosis of any cancer within the past 5 years, except skin cancer that is not melanoma, or currently being evaluated for a possible cancer.
  • Allergy to study drug: Known allergy to any component of the investigational medication.
  • Recent major trauma or surgery: Major injury or major surgery within the last 3 months, or planning major surgery during the trial.
  • Alcohol or substance abuse: Current misuse of alcohol or drugs that could interfere with following the study protocol.
  • Pregnancy and related restrictions: Women who are pregnant, breastfeeding, plan to become pregnant, or cannot agree to avoid egg donation or in‑vitro fertilization during the study.
  • Participation in other trials: Being enrolled in another clinical trial or having taken another study drug within a wash‑out period (usually 5 drug half‑lives or up to 6 months, whichever is longer).
  • Previous ASO or siRNA therapy: Prior treatment with antisense oligonucleotides (ASO) or small interfering RNAs (siRNA).
  • Recent immune‑modulating treatments: Use of strong immune‑suppressing medicines (e.g., long‑term steroids, methotrexate, biologic drugs) within 6 months, except short courses ≤2 weeks or topical/inhaled steroids; use of interferon within 12 months; recent vaccinations other than flu or COVID‑19; or current use of the drug bulevirtide.
  • Long‑term blood thinners or antiplatelet drugs: Need for ongoing anticoagulants (e.g., warfarin, factor Xa inhibitors) or antiplatelet agents (e.g., clopidogrel, regular aspirin) unless they can be safely stopped before the first dose.
  • Other unsuitable conditions: Any additional medical condition or circumstance that the investigator believes makes participation unsafe or inappropriate.
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Investigated drugs

  • AHB-137

    is an experimental drug that is being given by a small injection under the skin. In this study it is added to people who already have chronic hepatitis B and are taking their regular hepatitis B medicines. The purpose is to see if AHB-137 can improve the control of the virus and help keep the liver healthier.

  • nucleos(t)ide analogue therapy

    refers to the standard oral medicines that people with chronic hepatitis B usually take. These drugs work by stopping the virus from making new copies of itself. In the trial all participants continue their usual nucleos(t)ide analogue treatment, and the new drug AHB-137 is tested on top of this background therapy.

What is already known about the treatment

AHB-137 - This medication is given as a 300 mg subcutaneous injection, meaning it is delivered under the skin using a small needle. It is currently an investigational antiviral drug that is being studied in clinical trials and has not yet received market approval. The main use being tested is for people with chronic hepatitis B who are already on standard antiviral pills. AHB-137 works by attaching to a viral protein and stopping the hepatitis B virus from assembling new virus particles, placing it in the class of antiviral agents that target viral replication.

Investigated diseases

Chronic Hepatitis B - Chronic Hepatitis B is a long‑lasting infection of the liver caused by the hepatitis B virus. The virus remains in the body and repeatedly inflames liver cells, often without obvious symptoms. Over time the ongoing inflammation can lead to the buildup of scar tissue, a process called fibrosis. As fibrosis advances, the liver may become hardened and develop cirrhosis, which can impair its normal functions. Some people experience periods when the virus is less active, followed by episodes of increased activity, known as flares.
Trial detailsLast updated 25 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-524159-30-00Protocol codeAB-10-8012Estimated enrolment70 patients

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