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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Multiprofile Hospital For Active Treatment Hadji Dimitar OOD Sliven Bulgaria
Oncopole Claudius Regaud Toulouse France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Hospital Clinic De Barcelona Barcelona Spain
Centre Hospitalier Universitaire De Nice Nice France
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD Sofia Bulgaria
Centre Hospitalier Universitaire De Rennes Rennes France
Institutul National De Boli Infectioase Prof.Dr.Matei Bals Bucharest Romania
Hopital Beaujon Clichy France
Tokuda Hospital Sofia Bulgaria
Spitalul Clinic De Boli Infectioase Si Tropicale Dr. Victor Babes Bucharest Romania
Umbal – Prof. D-R Stoyan Kirkovich AD Stara Zagora Bulgaria
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Htxjmxnl Vjrj dtikmccx Barcelona Spain
Caetqs Htqzrszrbfp En Uiluzpecfyivg Dr Lxjyvln Limoges France
Anglbyi Omzhmjzalux Uxcxortkwmfem Currdfpccnpg Djqkg Sbrdso E Doqev Ssrcjxh Du Tpqfla Turin Italy
Cheeucup Hcjtlkyxzkxc Ubaynjwrbftgo Dn Vwvr Vigo Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Recruiting
01.09.2025
France France
Recruiting
01.09.2025
Italy Italy
Recruiting
01.09.2025
Romania Romania
Recruiting
01.09.2025
Spain Spain
Recruiting
01.09.2025

Trial locations

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.

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 ID:
2025-521178-33-00
Protocol code:
ALG-000184-202
Trial Phase:
Therapeutic exploratory (Phase II)

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