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Study comparing ALG-000184 with tenofovir disoproxil in untreated adults with chronic hepatitis B virus infection

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What is this trial about?

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

This study focuses on people with Chronic Hepatitis B Virus Infection, a long-term viral infection that affects the liver. The research compares two medications: a new drug called ALG-000184 and an existing treatment called Tenofovir Disoproxil. The study aims to determine how well ALG-000184 works compared to Tenofovir Disoproxil in treating hepatitis B infection in adults who have not previously received treatment.

The study includes two groups of patients: those who test positive for a specific hepatitis B marker called HBeAg and those who test negative for it. Some participants will receive ALG-000184, while others will receive Tenofovir Disoproxil or placebo. The treatment period lasts for 48 weeks, during which researchers will monitor how well the medications control the amount of hepatitis B virus in the blood.

Throughout the study, participants will have regular check-ups to monitor their health. These check-ups include blood tests to measure virus levels, liver function tests, physical examinations, and heart monitoring with ECGs. The total study duration may extend up to 96 weeks to ensure proper evaluation of the treatment's long-term effects and safety.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    You will be evaluated to confirm if you have chronic hepatitis B virus infection

    Your blood will be tested to check HBV DNA levels and other markers

    A physical examination and medical history review will be conducted

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either ALG-000184 or tenofovir disoproxil

    Neither you nor your doctor will know which medication you are receiving (double-blind study)

    Both medications are taken by mouth in tablet form

  3. Step 3

    48-week treatment period

    You will take your assigned medication daily for 48 weeks

    Regular blood tests will be performed to monitor your hepatitis B virus levels

    Your liver function will be checked through blood tests

    You will have physical examinations and vital signs checks

    Heart monitoring will be done using ECG (heart rhythm test)

    Urine samples will be collected for analysis

  4. Step 4

    Safety monitoring

    Any side effects or health changes will be recorded throughout the study

    Blood and urine tests will be regularly performed to monitor your health

    The study team will check your overall health status at scheduled visits

  5. Step 5

    Final evaluation

    At week 48, a final assessment of your response to treatment will be conducted

    Blood tests will be performed to measure hepatitis B virus levels

    Your liver function and overall health status will be evaluated

Who can join the trial?

9 criteria

  • Age between 18 and 65 years old with a body mass index (BMI) between 18.0 and 35.0 (BMI is a measure of body fat based on height and weight)
  • Must be either:
    • HBeAg-positive and HBeAb-negative (for Part 1 of study), or
    • HBeAg-negative (for Part 2 of study)
    • Must have hepatitis B surface antigen (HBsAg) level of 100 IU/mL or higher
    • Must have hepatitis B virus DNA level of 20,000 IU/mL or higher
    • Must have been diagnosed with chronic hepatitis B infection and have liver enzyme (ALT) levels no more than 8 times the upper normal limit during screening
    • Must meet one of these treatment conditions:
      • Never received any hepatitis B treatment before, or
      • Not taken any hepatitis B medications or experimental treatments in the past 6 months
      • Both men and women can participate in the study

Who cannot join the trial?

14 criteria

  • History of hepatocellular carcinoma (liver cancer) or suspected liver cancer
  • Previous liver transplant
  • Co-infection with HIV (Human Immunodeficiency Virus), HCV (Hepatitis C Virus), or HDV (Hepatitis D Virus)
  • Pregnant or breastfeeding women
  • Active substance abuse or alcohol dependency within the past 12 months
  • Significant heart, kidney, or mental health conditions
  • Current or recent treatment with immunosuppressive medications (drugs that weaken the immune system)
  • Participation in another clinical trial within 30 days
  • Known allergies to study medications
  • Severe liver disease or cirrhosis (scarring of the liver)
  • Abnormal blood test results showing poor liver or kidney function
  • History of autoimmune disease (conditions where the immune system attacks healthy cells)
  • Current treatment with medications that might interact with study drugs
  • Unable to comply with study procedures or follow-up visits
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Investigated drugs

  • ALG-000184

    is an investigational medication being studied for the treatment of chronic hepatitis B virus infection. It is being tested as a new potential therapy for patients who have not been previously treated for their condition.

  • Tenofovir Disoproxil Fumarate (TDF)

    is an established antiviral medication used to treat chronic hepatitis B infection. It works by preventing the hepatitis B virus from multiplying in the body. This medication has been widely used and is serving as the active control (comparison) treatment in this study.

What is already known about the treatment

  • ALG-000184

    An experimental medication being studied for the treatment of Chronic Hepatitis B Virus (HBV) infection. This novel drug is currently undergoing Phase 2 clinical trials, being compared with Tenofovir Disoproxil Fumarate in patients with both HBeAg-positive and HBeAg-negative chronic HBV infection. The primary focus of the research is to evaluate its effectiveness in reducing HBV DNA levels in the blood, though the specific mechanism of action is not publicly disclosed in current medical literature.

  • Tenofovir Disoproxil Fumarate

    An established antiviral medication administered orally in tablet form for the treatment of chronic Hepatitis B virus infection. It works by inhibiting viral DNA polymerase, thereby reducing the virus's ability to multiply in the body. This medication belongs to the nucleotide analog reverse transcriptase inhibitor class and has been widely used in clinical practice with well-documented effectiveness in suppressing HBV viral replication.

Investigated diseases

Chronic Hepatitis B - A viral infection that affects the liver, caused by the hepatitis B virus (HBV). The condition develops slowly over months or years, with the virus continuously replicating in liver cells. It can exist in two forms: HBeAg-positive and HBeAg-negative, which refers to the presence or absence of a specific viral protein in the blood. The infection causes inflammation of the liver tissue and may lead to liver cell damage. People with chronic hepatitis B may experience fatigue, mild fever, and abdominal discomfort, though some individuals show no symptoms. The virus remains in the body long-term and can be passed to others through blood and other body fluids.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521178-33-00Protocol codeALG-000184-202Estimated enrolment195 patientsSponsorAligos Therapeutics Inc.

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