Not yet recruitingPHASE2INTERVENTIONAL

Study of AHB-137 in Chronic Hepatitis B (CHB) Participants in North America and Europe Regions

This research study is looking into a new medication called AHB-137 for people who have long-term (chronic) hepatitis B. It's a phase 2 trial, meaning it's focusing on how effective the treatment is and if it's safe for patients. Participants will be adults who are already taking standard hepatitis B medicines (called nucleos(t)ide analogues). They will receive AHB-137 injections, and researchers will compare different groups to understand its impact. The goal is to find out if AHB-137 can help manage chronic hepatitis B more effectively and safely. This study is taking place in North America and Europe.

At a glance

Status

Not yet recruiting

Phase

PHASE2

Sponsor

AusperBio Therapeutics Inc.

Enrolment target

Start

17 Jun 2026

Estimated completion

26 Jul 2028

Hepatitis B, Chronic

What is this study about?

This study is about exploring a new treatment called AHB-137 for people living with chronic hepatitis B. Chronic hepatitis B is a long-lasting liver infection caused by the hepatitis B virus. While there are treatments available, researchers are always looking for new and better ways to help manage the condition and improve patients' health.

The main aim of this study is to see if AHB-137, given as an injection, is effective and safe when added to the usual medicines people take for hepatitis B. These usual medicines are called nucleos(t)ide analogues. This is a 'Phase 2' study, which means it's a key step in testing new medicines. Doctors are trying to understand how well the medicine works, what dosage might be best, and if there are any side effects.

Participants in the study will be adults who already have chronic hepatitis B and are on a stable dose of their current hepatitis B medication. By taking part, you could be helping doctors learn more about this new potential treatment and contribute to finding better ways to help people living with hepatitis B.

Key takeaways

Tests a new injection (AHB-137) for long-term hepatitis B.
For adults aged 18-65 already on hepatitis B medication.
Aims to check safety and how well it works.
Involves regular clinic visits, blood tests, and heart checks.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you need to be an adult between 18 and 65 years old. You must have had chronic hepatitis B for at least six months and already be taking a stable course of one of the commonly prescribed hepatitis B medications. Also, your weight and some blood test results, like those for your liver, need to be within specific ranges.

There are also some important things that would mean you couldn't join. For example, if you have other serious health conditions, especially liver diseases not related to hepatitis B, or recent severe infections, you wouldn't be able to take part. Also, if there's any suspicion of advanced liver scarring (cirrhosis), you would not be eligible.

For women, you can't be pregnant or breastfeeding, and if you could become pregnant, you'd need to agree to use effective birth control throughout the study and for some months afterwards. Men whose partners could become pregnant would also need to agree to use effective birth control.

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.

Are you between 18 and 65 years old?
Have you had chronic hepatitis B for at least 6 months?
Are you currently taking a stable dose of hepatitis B medication?
Do you have no other serious ongoing health conditions?
Are you, or your partner, willing to use effective contraception during the study if needed?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be given AHB-137 as an injection. This will happen alongside your current hepatitis B medication. The study is 'randomised,' meaning you'll be put into a treatment group by chance, and 'open-label,' meaning both you and the study team will know which treatment you are receiving.

You will have regular visits to the clinic for assessments. These will include blood tests to check how the medication is working and to monitor your general health, as well as heart checks (ECGs). You'll be asked to closely follow the study instructions, especially regarding your medication and any required follow-up appointments. If specific conditions are met during the study, you might need to stop your current hepatitis B medicine. The total duration of your participation, including follow-up after your last dose of AHB-137, will be explained in detail by the study team.

Potential risks and benefits

Taking part in a clinical trial like this may offer potential benefits, such as receiving a new investigational treatment that might help your condition, and you'll receive careful medical monitoring. However, there are also potential risks; for example, AHB-137 might cause side effects that are not yet fully known or might not be effective for everyone. You will be fully informed about all known risks before you decide to participate. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (9)

Stanford University
Verified postcode
Palo Alto, United States
University of Maryland
Verified postcode
Baltimore, United States
NYU Langone Health
Verified postcode
New York, United States
Texas Liver Institute
Verified postcode
San Antonio, United States
University of Calgary
Verified postcode
Calgary, Canada
Hôpital Beaujon
Verified postcode
Clichy, France
Clinica Mangiagalli
Verified postcode
Milan, Italy
Vall d'Hebron Hospital
Verified postcode
Barcelona, Spain
King's College Hospital
Verified postcode
London, United Kingdom

Common questions

What is AHB-137?

AHB-137 is a new medicine being tested as a possible treatment for long-term hepatitis B. It's given as an injection.

What does 'Phase 2' mean?

Phase 2 means the study is mainly checking how well the new medicine works and if it's safe for people to take, after earlier safety tests.

Will I still take my usual hepatitis B medicine?

Yes, if you join this study, you'll continue taking your current hepatitis B medicine, and AHB-137 will be given in addition to it, unless specific study conditions are met.

What is 'chronic hepatitis B'?

Chronic hepatitis B is a long-lasting liver infection caused by the hepatitis B virus.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, and it won't affect your regular medical care.

How to find out more

Maggie Davis

ausperbioclinicaltrials@ausperbio.com (650) 650-2877 Official trial record

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