Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2, Multicenter, Randomized, Double-blind, Placebo‑controlled Study with Deferred Active Treatment to Investigate the Efficacy, Safety, and Pharmacokinetics of JNJ‑73763989 + Nucleos(t)ide Analog in Participants Co‑infected with Hepatitis B and Hepatitis D Virus

This study is testing a new medicine called JNJ-73763989 for people who have both Hepatitis B and Hepatitis D, which are liver infections. We want to find out if this new medicine can help by reducing the amount of Hepatitis D virus in the body and improving liver health. Some people will get the new medicine, while others will get a dummy treatment (a 'placebo') to help us compare. After a certain time, those who received the dummy treatment will get the active medicine. We'll be carefully checking how effective and safe the new medicine is, and how the body processes it. Everyone in the study will be at least 18 years old.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Janssen - Cilag International

Enrolment target

Start

08 Feb 2024

Hepatitis B and Hepatitis D Viral Co-infection

What is this study about?

This study is designed to explore a new treatment, JNJ-73763989, for individuals living with both Hepatitis B and Hepatitis D viruses. These viruses can cause serious liver problems, and having both at the same time can make the disease more severe. Currently, treatment options for Hepatitis D are limited, so finding new and effective medicines is really important.

The main goal of this study is to see if JNJ-73763989 can significantly lower the amount of Hepatitis D virus in your body and help your liver function better. We are also carefully watching for any side effects to understand how safe the new treatment is. Understanding how the body handles the medicine is also a key part of our research. Participants will be divided into groups, with some receiving the new medicine and others receiving a 'placebo' – a treatment that looks like the study drug but contains no active medicine. This helps researchers fairly compare the effects. After a period, everyone will get the active medicine.

By taking part in studies like this, you could contribute to developing new and better treatments for Hepatitis B and Hepatitis D, potentially improving the lives of many people in the future. The information gathered from this research will help doctors understand more about combining treatments and improving care for these conditions.

Key takeaways

This study is testing a new medicine for people with both Hepatitis B and Hepatitis D.
It aims to see if the new medicine, JNJ-73763989, lowers virus levels and improves liver health.
Some participants will get the new medicine, others a dummy treatment initially.
All participants will eventually receive the active study medicine.
Regular clinic visits, blood tests, and health checks will be part of taking part.
Participation could help develop future treatments for these conditions.

Who may be eligible?

This study is looking for adults who have both Hepatitis B and Hepatitis D. You must be at least 18 years old to take part; there's no upper age limit.

When doctors say you have "co-infection," it simply means you've tested positive for both Hepatitis B and Hepatitis D at the same time. The medical team will check your specific health records to make sure you fit all the detailed requirements for the study.

It's important to know that certain past medical conditions or current medications might mean you're not able to join, even if you have both viruses. The study doctors will carefully review your health information to confirm if this study is right for you.

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 18 years old or older?
Have you been diagnosed with both Hepatitis B and Hepatitis D?
Are you able to attend regular clinic appointments?
Are you willing to potentially receive a dummy treatment for a period?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you'll be assigned to one of two groups by chance – like flipping a coin. One group will receive the new study medicine, JNJ-73763989, along with other standard treatments. The other group will initially receive a placebo (a dummy treatment) along with standard treatments. After a period of time, those who were on the placebo will switch to receive the active study medicine. The medicines might be given as tablets or injections, and you'll receive detailed instructions on how to take them.

You'll have regular visits to the clinic, where the study team will carry out various health checks. These will include blood tests to measure the amount of virus in your body, check your liver health, and look for any side effects. You'll also have physical exams and possibly other tests like liver scans. These visits help us monitor your health and how the treatment is working. The study will last for a specific period, followed by a follow-up period to make sure you're doing well and to collect final information. The overall total duration of your involvement could be over a year, but the team will explain the exact schedule.

Potential risks and benefits

Participating in research studies comes with potential benefits and risks. A potential benefit of this study is that you might receive access to a new treatment, JNJ-73763989, which could help your Hepatitis B and D infections. However, there's no guarantee it will work for everyone, and it's also possible you might initially receive the placebo. Potential risks could include side effects from the study medication or from the procedures involved, like discomfort from blood tests. We will monitor you very closely for any side effects. Remember, joining this study is completely voluntary, and you have the right to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Sweden
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Unverified
Italy
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Unverified
France

Common questions

What is Hepatitis B and D co-infection?

It means you have both the Hepatitis B virus and the Hepatitis D virus in your body at the same time. This can make liver problems more serious.

What is a 'dummy treatment' (placebo)?

It looks exactly like the study medicine but doesn't contain any active drug. It helps researchers compare the real effects of the new medicine.

Will I know if I'm getting the new medicine or the placebo?

No, this is a 'blinded' study, meaning neither you nor your study doctor will know initially. This helps ensure fair results.

How long will I be involved in the study?

The study involves regular clinic visits and treatment for a specific period, followed by a follow-up, which could be over a year in total. The team will give you a detailed timeline.

Can I leave the study if I change my mind?

Yes, you are free to withdraw from the study at any time, for any reason, and it will not affect your ongoing medical care.