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RecruitingPHASE2INTERVENTIONAL

A Study Evaluating the Efficacy and Safety of ALG-000184 Compared With Tenofovir Disoproxil Fumarate in Untreated HBeAg-Positive and HBeAg- Negative Adult Subjects With Chronic Hepatitis B (B-SUPREME)

This research study, called B-SUPREME, is testing a new medicine, ALG-000184, for adults with chronic hepatitis B infection. It aims to see how well it works and how safe it is compared to a widely used treatment called tenofovir. Participants will take one of the two medicines by mouth once a day for 48 weeks. The study is split into two groups: one for people with a specific type of hepatitis B (HBeAg-positive) and another for a different type (HBeAg-negative). After the main 48-week period, everyone will have the option to continue taking the new drug, ALG-000184, for another 48 weeks. This study hopes to find out if ALG-000184 could be a good new option for treating chronic hepatitis B.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
Aligos Therapeutics
Enrolment target
200
Start
15 Jul 2025
Estimated completion
01 Aug 2028

What is this study about?

This study is investigating a new oral medication called ALG-000184 for people living with chronic hepatitis B. Chronic hepatitis B is a long-lasting infection of the liver that can lead to serious health problems over time. The main goal of this study is to compare the new drug with an existing and well-known treatment called tenofovir. Researchers want to understand if ALG-000184 is as effective, or even more effective, and importantly, how safe it is for patients.

Participants will be randomly assigned to receive either the new drug or tenofovir, and neither they nor their doctors will know which treatment they are getting during the main part of the study. This setup helps ensure the results are fair and unbiased. The study will last for at least 48 weeks, where everyone takes their assigned medication daily. There are two main groups within the study, focusing on different types of chronic hepatitis B based on a specific marker called HBeAg.

After completing the initial 48 weeks, all participants will have the opportunity to continue taking ALG-000184 for an additional 48 weeks. This allows researchers to gather more information about its long-term effects and safety. The insights gained from this study could help doctors in the future offer more treatment options to individuals with chronic hepatitis B, potentially improving their health outcomes.

Key takeaways

  • This study is testing a new drug for chronic hepatitis B.
  • It compares the new drug (ALG-000184) to a common treatment (tenofovir).
  • It involves taking a pill once a day for at least 48 weeks.
  • The study aims to check how well the new drug works and if it's safe.
  • You'll get regular health checks and doctor visits if you participate.
  • You can choose to leave the study at any time.

Who may be eligible?

To join this study, people need to be adults between 18 and 65 years old and have been diagnosed with chronic hepatitis B. You must not have received treatment for hepatitis B before, or if you have, it must have been a long time ago (at least 6 months) and you are not currently taking any medicines for it. Your liver health will also be checked to make sure it meets specific levels for the study.

There are certain reasons why someone couldn't join. For example, if you also have other types of hepatitis (like A, C, D, or E) or HIV, or if you have any signs of serious liver problems like cirrhosis (scarring of the liver), severe liver damage, or a history of liver cancer. Also, if you've recently taken part in another medical study involving a new drug or device, you would not be able to join this one.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you between 18 and 65 years old?
  2. Do you have chronic hepatitis B?
  3. Have you never taken hepatitis B medication before, or stopped long ago?
  4. Do you have good overall liver health (as assessed by doctors)?
  5. Do you *not* have other liver diseases or HIV?
  6. Do you *not* have a history of serious liver problems like cirrhosis or liver cancer?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be assigned to take either the new drug, ALG-000184, or an existing medicine, tenofovir. You'll take one tablet by mouth once a day for 48 weeks. Neither you nor your study doctor will know which treatment you are on during this time. Throughout these 48 weeks, you will have regular visits to the clinic for medical check-ups, blood tests, and to discuss any side effects you might be experiencing. Some participants will also have a liver biopsy (a small sample of liver tissue taken) at the beginning and end of the main 48-week period.

After the first 48 weeks, you'll have the option to continue in the study for another 48 weeks, where everyone will receive ALG-000184. This means the total time you could be involved in the study is about 96 weeks (nearly two years). There will be regular follow-up appointments and tests throughout this entire period to monitor your health and how the treatment is working.

Potential risks and benefits

Taking part in this study could offer potential benefits, such as access to a new experimental medicine for chronic hepatitis B. You'll also receive careful medical monitoring from a team of specialists. However, there are potential risks, as with any medication. The new drug's full side effect profile isn't completely known yet, and tenofovir also has known side effects, which your doctor will explain. There's also the chance the treatment might not work for you. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (58)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Aligos Investigational Site
    Verified postcode
    Chandler, United States· Recruiting
  • Aligos Investigational Site
    Verified postcode
    Coronado, United States· Recruiting
  • Aligos Investigational Site
    Verified postcode
    Garden Grove, United States· Recruiting
  • Aligos Investigational Site
    Verified postcode
    Los Angeles, United States· Recruiting
  • Aligos Investigational Site
    Verified postcode
    Palo Alto, United States· Recruiting
  • Aligos Investigational Site
    Verified postcode
    Pasadena, United States· Recruiting
  • Aligos Investigational Site
    Verified postcode
    Rialto, United States· Recruiting
  • Aligos Investigational Site
    Verified postcode
    San Francisco, United States· Recruiting
  • Aligos Investigational Site
    Verified postcode
    San Jose, United States· Recruiting
  • Aligos Investigational Site
    Verified postcode
    Miami, United States· Recruiting
  • Aligos Investigational Site
    Verified postcode
    Miami, United States· Recruiting
  • Aligos Investigational Site
    Verified postcode
    Marrero, United States· Recruiting

Common questions

What is chronic hepatitis B?

Chronic hepatitis B is a long-lasting viral infection that affects your liver. It can lead to liver damage over time if not managed.

What is the new medicine being tested?

The new medicine is called ALG-000184. This study is comparing it with an existing treatment called tenofovir.

How long does the study last?

The main part of the study lasts for 48 weeks. You might have the option to continue for another 48 weeks, making the total up to 96 weeks (almost two years).

Will I know which medicine I'm getting?

During the first 48 weeks, neither you nor your doctor will know if you're taking the new drug or tenofovir. This is done to make the results fair.

Can I leave the study at any time?

Yes, you can choose to leave the study at any point and for any reason. Your decision will not affect your future medical care.

How to find out more

Aligos Therapeutics

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Study Evaluating the Efficacy and Safety of ALG-000184 Com…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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